Epilepsy

Clinical Outcome Data of Children Treated with Cannabis-Based Medicinal Products for Treatment Resistant Epilepsy—Analysis from the UK Medical Cannabis Registry

Simon Erridge, Carl Holvey, Ross Coomber, Jonathan Hoare, Shaheen Khan, Michael W. Platt, James J. Rucker, Mark W. Weatherall, Sushil Beri, Mikael H. Sodergren (January 2023)

Thirty-five patients were included in the analysis. Patients were prescribed during their treatment with the following: CBD isolate oils (n = 19), CBD broad-spectrum oils (n = 17), and CBD/Δ9-THC combination therapy (n = 17). Twenty-three (65.7%) patients achieved a ≥50% reduction in seizure frequency. 94.1% (n = 16) of patients treated with CBD and Δ9-THC observed a ≥50% reduction in seizure frequency compared to 31.6% (n = 6) and 17.6% (n = 3) of patients treated with CBD isolates and broad-spectrum CBD products, respectively (p< 0.001). Twenty-six (74.3%) adverse events were reported by 16 patients (45.7%). The majority of these were mild (n = 12; 34.2%) and moderate (n = 10; 28.6%).

The results of this study demonstrate a positive signal of improved seizure frequency in children treated with Cannabis-based medicinal products (CBMPs) for TRE. Moreover, the results suggest that CBMPs are well-tolerated in the short term. The limitations mean causation cannot be determined in this open-label, case series.

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Long-term Efficacy and Safety of Cannabidiol in Patients with Treatment-resistant Epilepsies: Four-year Results from the Expanded Access Program

Jerzy P. Szaflarski, Orrin Devinsky, Merrick Lopez, Yong D. Park, Pilar Pichon Zentil, Anup D. Patel, Elizabeth A. Thiele, Robert T. Wechsler, Daniel Checketts, Farhad Sahebkar (December 2022)

Patients received plant-derived highly purified CBD (Epidiolex®; 100 mg/ml oral solution), increasing from 2 to 10 mg/kg/day to tolerance or maximum 25–50 mg/kg/day dose, depending on the study site.

Of 892 patients in the safety analysis set, 322 (36%) withdrew; lack of efficacy (19%) and AEs (7%) were the most commonly reported primary reasons for withdrawal. Median (range) age was 11.8 years (range = 0–74.5), and patients were taking a median of three (range = 0–10) antiseizure medications (ASMs) at baseline; the most common ASMs were clobazam (47%), levetiracetam (34%), and valproate (28%). Median top CBD dose was 25 mg/kg/day; median exposure duration was 694 days. Median percentage reduction from baseline ranged 50%–67% for convulsive seizures and 46%–66% for total seizures. Convulsive seizure responder rates (≥50%, ≥75%, and 100% reduction) ranged 51%–59%, 33%–42%, and 11%–17% of patients across visit windows, respectively. AEs were reported in 88% of patients and serious AEs in 41%; 8% withdrew because of an AE. There were 20 deaths during the study deemed unrelated to treatment by the investigator. The most common AEs (≥20% of patients) were diarrhea (33%), seizure (24%), and somnolence (23%).

Add-on CBD was associated with sustained seizure reduction up to 192 weeks with an acceptable safety profile and can be used for long-term treatment of TREs.

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If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Outcomes from a Spanish Expanded Access Program on Cannabidiol Treatment in Pediatric and Adult Patients with Epilepsy

Vicente Villanueva, Adrián García-Ron, Patricia Smeyers, Eva Arias, Victor Soto, Juan José García-Peñas, Elena González-Alguacil, Débora Sayas, Pedro Serrano-Castro, Mercedes Garces, Kevin Hampel, Miguel Tomás, Julian Lara, María de Toledo, Ines Barceló, Angel Aledo-Serrano, Antonio Gil-Nagel, Lucas Iacampo, Mercè Falip, Rosa Ana Saiz-Diaz, Asier Gómez-Ibañez, David Sopelana, Alvaro Sanchez-Larsen, Francisco Javier López-González (October 2022)

One hundred and two patients (DS 12 %; LGS 59 %; other epilepsy syndromes 29 %) with a mean age of 15.9 years were enrolled. Patients were highly refractory to antiseizure medications (ASMs); mean number of prior failed ASMs was 7.5 (SD 3.7). The mean CBD dose was 13.0 mg/kg/day at the last visit. The proportion of patients with ≥50 % reduction in the total number of seizures from baseline was 44.9 % at 6 months and 38.9 % at 12 months. The median number of total seizures per month reduced by 47.6 % from baseline to the last visit. At 12 months, seizure severity was lower in 33/54 patients (61.1 %) and unchanged in 17/54 patients (31.5 %). Quality of life, based on the CAVE scale, increased from a mean score of 17.9 ± 4.7 (n = 54) at baseline to 21.7 ± 5.5 (n = 51) at the last patient visit (21.2 % improvement). The mean treatment retention time was 10.3 months. There were no statistically significant changes in the number of status epilepticus episodes, but lower healthcare utilization was observed.

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The Long-Term Effectiveness And Safety Of Cannabidiol-Enriched Oil In Children With Drug-Resistant Epilepsy

Michal Tzadok MD, Nasrin Hamed MD, Gali Heimer MD, PhD, Efrat Zohar-Dayan MD,Shira Rabinowicz MD, Bruria Ben Zeev MD (June 2022)

This is a retrospective study of children and adolescents with refractory epilepsy caused by various etiologies who were treated with artisanal cannabis oil during January 2014 to June 2019, with at least one year follow-up.

Of 114 patients, 84 (73.3%) reported some improvement in seizure frequency at some point during treatment. Fifty-one (59%) of the 86 patients who continued treatment for at least one year showed >50% improvement in seizure frequency. Seizure etiology, seizure type, and patients' age and sex were not found to be associated with the response to cannabidiol-enriched cannabis oil. Side effects were minor, and positive effects beyond seizure reduction were noted.

Artisanal cannabidiol-enriched cannabis may be an effective and safe long-term treatment for refractory epilepsy.

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Cannabidiol Decreases Seizure Severity And Brain Temperature In Treatment-Resistant Epilepsy

Ayushe Sharma, Jerzy Szaflarski (May 2022)

CBD’s efficacy in TRE may stem from targeting neuroinflammation. Brain temperature elevations (TCRE=−102.61(ΔH20−CRE)+206.1°C) may be considered a proxy for neuroinflammation and can be non-invasively mapped using magnetic resonance spectroscopic imaging and thermometry (MRSI-t). Although MRSI-t studies have documented TCRE elevations in TRE patients’ seizure onset zones (SOZs), no study has investigated if TCRE are affected by a treatment that has anti-inflammatory effects (CBD).

Baseline TCRE elevations (>37.5°C) were localized to clinically implicated seizure generation and/or propagation sites. All participants’ seizure severity (p=0.015) and brain temperature (p<0.0001) decreased from baseline to on-CBD. There was also a non-significant decrease in POMS TMD.

MRSI-t documented TCRE decreases in patients treated with CBD for treatment-resistant epilepsy. The observed effects may be related to CBD exposure, decreased seizure frequency/severity, or both. TCRE derived from MRSI-t may be a promising imaging-based biomarker for tracking neuroinflammation in patients with neurological conditions including epilepsy. Future findings from this on-going study will provide critical insights into CBD’s effects in the human brain.

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Long-Term Use Of Cannabidiol-Enriched Medical Cannabis In A Prospective Cohort Of Children With Drug-Resistant Developmental And Epileptic Encephalopathy

Roberto Caraballo, Gabriela Reyes, Graciela Demirdjian, Marina Huaman and Robinson Gutierrez (January 2022)

Between October 2018 and March 2020, 59 patients were enrolled. Mean age at enrollment was 10.5 years (range, 2–17 years). Median treatment duration was 20 months (range, 12–32). Median age at first seizure was 8 months (range, 1 day – 10 years). At the end of follow-up, 78% of the children had a ≥ 50% decrease in seizure frequency and 47.5% had a > 75% decrease. Seven patients (11.9%) were seizure free. The number of seizures was reduced from a median of 305/month to 90/month, amounting to a mean reduction of 57% and a median reduction of 71% (p < 0.0001). Adverse effects were mostly mild or moderate. CBD was discontinued in 17 patients (28.8%) due to lack of response to treatment, increased seizure frequency, intolerance to the drug, or poor compliance.

In children with drug-resistant DEEs, long-term treatment of CBD-enriched medical cannabis as an adjuvant therapy to antiseizure therapy was found to be safe, well tolerated, and effective. Sustained reductions in seizure frequency and improvement of aspects of daily living were observed compared to our preliminary findings.

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Cannabidiol-Enriched Medical Cannabis As Add-On Therapy In Children With Treatment-Resistant West Syndrome: A Study Of Eight Patients

Roberto Carabello, Gabriela Reyes Valenzuela (October 2021)

Eight patients (six female and two male) who received CBD for treatment-resistant WS were evaluated. Ages ranged from 16 to 22 months. The etiology was unknown in five and structural in three. Initial CBD dose was 2 mg/kg/day which was uptitrated to a median dose of 12 mg/kg/day (range, 2–25). Prior to CBD initiation, patients had a mean of 63 seizures per day (range, 31–79). After a follow-up of between 6 and 13 months, a 75–99% decrease in seizure frequency was observed in two patients, a 50–74% decrease in two, a less than 50% decrease in three, and no changes in seizure frequency were seen in the remaining patient. The index of EEG abnormalities improved between 20 and 80% in seven patients concurrently with the reduction in seizures. Adverse effects were mild and transient. Somnolence was observed in one patient, nausea and vomiting in one, and behavior disturbances and irritability in another patient.

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If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Add-On Cannabidiol In Patients With Dravet Syndrome: Results Of A Long-Term Open-Label Extension Trial

Ingrid E. Scheffer, Jonathan J. Halford, Ian Miller, Rima Nabbout, Rocio Sanchez-Carpintero, Yael Shiloh-Malawsky, Matthew Wong, Marta Zolnowska, Daniel Checketts, Eduardo Dunayevich, Orrin Devinsky (August 2021)

Add-on cannabidiol (CBD) reduced seizures associated with Dravet syndrome (DS) in two randomized, double-blind, placebo-controlled trials: GWPCARE1 Part B (NCT02091375) and GWPCARE2 (NCT02224703). Patients who completed GWPCARE1 Part A (NCT02091206) or Part B, or GWPCARE2, were enrolled in a long-term open-label extension trial, GWPCARE5 (NCT02224573).

In patients from GWPCARE1 Part B and GWPCARE2, the median reduction from baseline in monthly seizure frequency assessed in 12-week periods up to Week 156 was 45%–74% for convulsive seizures and 49%–84% for total seizures. Across all visit windows, ≥83% patients/caregivers completing a Subject/Caregiver Global Impression of Change scale reported improvement in overall condition.

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If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Long-Term Safety And Efficacy Of Highly Purified Cannabidiol For Treatment Refractory Epilepsy

Tyler E. Gaston, Steve B. Bebin, Leslie P. Grayson, Gary R. Cutter, Kathleen Hernando, Jerzy P. Szaflarski, for the UAB CBD Program (April 2021)

Children displayed 52% seizure reduction at month 1, a 51% reduction at year 1, and 75% reduction at year 2. Seizure reductions in adults were 60%, 81%, and 85%, respectively (all P < 0.0001). While there were no significant differences between seizure frequency reduction between children and adults at all time points, there was a significant difference in seizure severity reduction at year 1, with adults reporting greater improvement in seizure severity (P < 0.001). The most commonly reported adverse events in the study period were diarrhea, sedation, and decreased appetite. AEP revealed significant improvement from baseline at multiple time points in adults and children, and the mean AEP scores were always lower compared to baseline over the duration of the study.

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Highly Purified Cannabidiol For Epilepsy Treatment: A Systematic Review Of Epileptic Conditions Beyond Dravet Syndrome And Lennox-Gastaut Syndrome

Simona Lattanzi, Eugen Trinka, Pasquale Striano, Chaira Rocchi, Sergio Salvemini, Mauro Silvestrini & Francesco Brigo (March 2021)

Five hundred and seventy records were identified by database and trial register searching. Fifty-seven studies were retrieved for detailed assessment, of which 42 were eventually included for the review. The participants of the studies included patients of both pediatric and adult age. Across the trials, purified CBD was administered at dosages up to 50 mg/kg/day. In a randomized double-blind controlled trial in patients with tuberous sclerosis complex, CBD was associated with a significantly greater percent reduction in seizure frequency than placebo over the treatment period. Open-label studies suggested the effectiveness of CBD in the treatment of children and adults presenting with other epilepsy syndromes than those addressed by regulatory trials, including CDKL5 deficiency disorder and Aicardi, Dup15q, and Doose syndromes, SYNGAP1 encephalopathy, and epilepsy with myoclonic absences. The most common adverse events observed during treatment with CBD included somnolence, decreased appetite, diarrhea, and increased serum aminotransferases.

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If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Long-Term Efficacy And Safety Of Cannabidiol (CBD) In Children With Treatment-Resistant Epilepsy: Results From A State-Based Expanded Access Program

Yong D. Park, Daniel F. Linder, Jamie Pope, Katherine Moretz, Michael P. Diamond, Sarah A. Long (September 2020)

An intermediate-sized, multicenter, expanded-access study was opened in 2015 through the support of the State of Georgia. This study provided children with treatment-resistant epilepsy (TRE) access to plant-derived high purified cannabidiol (CBD; Epidiolex® in the US; Epidyolex® in the EU; 100mg/ml oral solution). These children had failed to achieve seizure freedom with available treatment options and were ineligible to participate in randomized controlled trials that only included patients with Lennox-Gastaut and Dravet syndromes.

This study supports CBD as an adjunctive treatment for children with TRE. Treatment was well tolerated in doses up to 50mg/kg/day. Patients who did not achieve desired results at a dose of ≤ 25.0 mg/kg/day reported more adverse events when CBD increased to > 25.0 mg/kg/day. Decreases in major seizure frequency and an increase in seizure-free days compared with baseline were reported during treatment. This supports the efficacy and tolerability of CBD for mixed seizure etiologies.

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If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Cannabis, More Than Euphoria: Its Therapeutic Use In Drug-Resistant Epilepsy

Keri-Ann Buchanan-Peart, Geraldine I. Oribhador, Rhutuja V. Khokale, Maxine L. Nelson, Ivan Cancarevic (July 2020)

A significant number of epilepsy patients are refractory to conventional antiepileptic drugs. These patients experience considerable neurocognitive impairments that impact their quality of life and ability to function independently. This need for alternative treatment has generated increased interest in cannabis use as a therapeutic option in these patients.

Drug resistant epilepsy (DRE) prevalence consists of 30% of people who have epilepsy, which has led to increased interest and research on the efficacy and safety of cannabis use as an adjunct in these patients. In 2014, Maa and Figi reported a case of a young girl with DS. After using a titrated dose of high concentration CBD: THC strain of cannabis (called Charlotte’s Web) coupled with her antiepileptic medication, it was reported that by her third month, she had a >90% reduction in generalized tonic-clonic (GTC) seizures. After 20 months of using this drug, she reported having only 2-3 nocturnal GTC seizures per month, having had in excess of 300 seizures per month prior to its use.

Cannabis mediates the ECS, which affects neuronal excitability. This makes it a superior choice for the adjunctive treatments of DRE patients. Studies have shown that cannabis use, primarily its CBD component, resulted in at least 50% seizure reduction in these patients. Additional positive effects included improvements in mood, alertness, sleep, language skills, which led to improved quality of life.

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Cognitive Function And Adaptive Skills After One-Year Trial Of Cannabidiol (CBD) In A Pediatric Sample With Treatment-Resistant Epilepsy

Matthew D. Thompson, Roy C. Martin, Leslie P. Grayson,  Gary Cutter, Jerzy P. Szaflarski, E. Martina Bebin (July 2020)

Participants between the age of 3 and 19 years with TRE were enrolled in an open-label study of a pharmaceutical formulation of CBD (Epidiolex®; GW Research Ltd.) as an add-on treatment.

Findings suggest that CBD, as an add-on drug for TRE in a pediatric sample, does not appear to cause adverse effects involving cognition or adaptive function over one year of treatment.

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Safety and Pharmacokinetics Of Medical Cannabis Preperations In A Monocentric Series of Young Patients With Drug Resistant Epilepsy

Marcella Gherzi, Giula Milano, Carmen Fucile, Maria Grazia Calevo, Maria Margherita Mancardi, Lino Nobili, Pietro Astuni, Valeria Marini, Sebastiano Barco, Giuliana Cangemi, Luca Manfredini, Francesca Mattioli, Elisa De Grandis (June 2020)

The present study, although with some limitations, shows a good safety profile of medical cannabis in children and young patients with drug-resistant epilepsy and encourages the possibility of further studies with oral cannabis-based drugs. The correlations between THC-CBD plasma concentrations and their administered dosages underline the need of a therapeutic drug monitoring for cannabinoids therapy.

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Plant Derived Versus Synthetic Cannabidiol: Wishes And Commitment Of Epilepsy Patients

Randi von Wrede, Susanna Moskau-Hartmann, Nicola Amarell, Rainer Surges, Christian Erich Elger, Christoph Helmstaeder  (June 2020)

A special component of cannabis, cannabidiol (CBD), is currently in the focus of epilepsy treatment and research. In this context, we investigated patients’ expectations and preferences pertaining to plant-derived versus synthetic formulation of cannabidiol, as well as their willingness to get this treatment.

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If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Cannabidiol Oral Solution: Challenges As A Treatment for Seizure Syndromes

Justin Sherman, Daniel Riche And Caroline Warren (January 2020)

Cannabidiol oral solution (Epidiolex) is an effective adjunctive agent for treatment-resistant seizures associated with Lennox-Gastaut syndrome and Dravet syndrome. Doses of Epidiolex should be reduced for patients with significantly compromised liver function, and transaminase levels should be monitored. Epidiolex is considered schedule V because oil or other derivatives or extracts made from cannabis seeds with a THC concentration of less than 0.3% are no longer as stringently controlled under the Controlled Substances Act.

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If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Efficacy Of Cannabidiol In Subjects With Refractory Epilepsy Relative To Concomitant Use of Clobazam

Taylor Savage, Jo Sourbron, Patricia Bruno and Lauren Skirvin (January 2020)

We analyzed data from 47 subjects between the ages of 2.5-51 years. There was no significant difference between the concomitant CLB (n = 32) and no concomitant CLB (n = 15) groups in terms of demographics (age (p = 0.4344), race (p = 1.0000), sex (p = 0.7507)) or most epilepsy characteristics (underlying condition (all p > 0.05), mean baseline seizure frequency (p = 0.6483)). There was only one significant difference between groups regarding seizure types (more subjects with epileptic spasms in concomitant CLB group (p = 0.0413)). Concomitant AED usage was not significantly different in the two groups (all p > 0.05). Mean reduction in weekly seizure frequency was greater at the best point of seizure control within the first year than at two months of treatment with CBD, regardless of concomitant CLB usage (all p > 0.05). There was no significant difference in reduction of mean weekly seizure frequency between those who took concomitant CLB and those who did not at either time point (all p > 0.05)

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If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Potential role of cannabidiol for seizure control in a patient with recurrent glioma

Kristin Hsu, Emma Whitman and Ganessan Kitchadasse (December 2019)

Glioma-related epilepsy significantly impact on patients’ quality of life, and can often be difficult to treat. Seizures cause significant morbidity for example neurocognitive deterioration, which may result from seizures themselves or due to adverse effects from antiepileptic drugs. Management of tumour with surgery, radiotherapy and chemotherapy may contribute to seizure control, but tumour related epilepsy is often refractory despite adequate treatment with standard anti-epileptic medications. Given the increasing interest in medicinal cannabis (or cannabidiol or CBD) as an anti-epileptic drug, CBD may help with seizure control in glioma patients with treatment-refractory seizures. Here we present a case of a young lady with recurrent glioma who had refractory seizures despite multiple anti-epileptic agents, who had significant benefit with CBD.

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If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Cannabis-Based Products For Pediatric Epilepsy: An Updated Systematic Review

Jesse Elliott, Deirdre DeJean, Tammy Clifford, Doug Coyle, Beth Potter, Becky Skidmore, Christine Alexander, Alexander Repetski, Vijay Shukla, Bláthnaid McCoy and George Wells (December 2019)

We updated our earlier systematic review, by searching for studies published up to May 2019. We included randomized controlled trials (RCTs) and non-randomized studies (NRS) involving cannabis-based products administered to children with epilepsy. Outcomes were seizure freedom, seizure frequency, quality of life, sleep, status epilepticus, death, gastrointestinal adverse events, and emergency room visits.

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If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

The Use Of Medical Grade Cannabis In Italy For Drug-Resistant Epilepsy: A Case Series

Chiara Pane and Francesco Sacca (December 2019)

In Italy, medical grade cannabis (MGC) can be prescribed for different medical conditions, including drug-resistant epilepsy (DRE), once standard and approved therapies have failed, or caused non-tolerable side effects. Here, we present a retrospective case series report of five patients with DRE who started therapy with MGC. Authorized ISO 9001:2008 pharmacies prepared MGC according to Italian laws. Olive oil extracts (OOEs) were prepared following standard extraction protocols, and cannabinoids were measured on each OOE to check for successful extraction.After treatment with MGC, all patients reported a reduction in seizure frequency and severity, and some reported improved mood, sleep quality, and general well-being without relevant side effects. Despite the small sample size and open-label nature of the data, we show that MGC may be successfully used to treat DRE. This is especially true when considering that no valid therapeutic option exists for these patients and that MGC was extremely well tolerated.

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If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Efficacy And Adverse Event Profile Of Cannabidiol And Medicinal Cannabis For Treatment-Resistant Epilepsy: Systematic Review And Meta-Analysis

Renandro de Carvalho Reis, Kelson James Almeida, Luciano da Silva Lopes, Cíntia Maria de Melo Mendes, Edson Bor-Seng-Shu (November 2019)

This paper aimed to systematically examine the efficacy and adverse event (AE) profile of cannabidiol and medicinal cannabis by analyzing qualitative and meta-analytic data. We used the terms (“Cannabidiol” OR “Cannabis”) AND “Epilepsy” AND (“Treatment” OR “Therapeutics”) as keywords to retrieve studies indexed on PubMed, ScienceDirect, and CENTRAL databases. The inclusion criteria were as follows: clinical studies with a longitudinal observational design and intervention using cannabinoid derivatives, especially cannabidiol and medicinal cannabis, whereby some results involved the frequency of epileptic seizures. We used Cochrane Collaboration's Review Manager software (RevMan 5.1.6) for the meta-analysis and dichotomized the articles to a confidence interval of 95%. From 236 articles, we selected 16 for descriptive analysis; we selected only 4 for the meta-analysis. According to the results, a statistically meaningful effect of cannabidiol compared with placebo was observed (p < 0.00001). When comparing treatment with cannabidiol or medicinal cannabis, significance was not found for the AE profile (p = 0.74). As AEs for cannabidiol were more common under short-term than under long-term treatment (p < 0.00001), this approach was favorable in the long term. Furthermore, cannabidiol is more effective than placebo, regardless of the etiology of epileptic syndromes and dosage. Overall, the AE profile did not differ across treatments with cannabidiol or medicinal cannabis, though it did differ favorably for long-term than for short-term treatment.

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If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Cannabidiol Attenuates Seizures And EEG Abnormalities In Angelman Syndrome Model Mice

Bin Gu, Manhua Zhu, Madison R. Glass, Marie Rougié, Viktoriya D. Nikolova, Sheryl S. Moy, Paul R. Carney and Benjamin D. Philpot (September 2019)

Angelman syndrome (AS) is a neurodevelopmental disorder characterized by intellectual disability, lack of speech, ataxia, EEG abnormalities, and epilepsy. Seizures in AS individuals are common, debilitating, and often drug-resistant. Therefore, there is an unmet need for better treatment options. Cannabidiol (CBD), a major phytocannabinoid constituent of cannabis, has antiseizure activity and behavioral benefits in preclinical and clinical studies for some disorders associated with epilepsy, suggesting that the same could be true for AS. Here we show that acute CBD (100 mg/kg) attenuated hyperthermia- and acoustically-induced seizures in a mouse model of AS. However, neither acute CBD nor a two-weeklong course of CBD administered immediately after a kindling protocol could halt the pro-epileptogenic plasticity observed in AS model mice. CBD had a dose-dependent sedative effect, but did not have an impact on motor performance. CBD abrogated the enhanced intracortical local field potential power, including delta and theta rhythms observed in AS model mice, indicating that CBD administration could also help normalize the EEG deficits observed in individuals with AS. Our results provide critical preclinical evidence supporting CBD treatment of seizures and alleviation of EEG abnormalities in AS, and will thus help guide the rational development of CBD as an AS treatment.

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Cannabis and Epilepsy

Alexander Doyle and Jay Harvey (August 2019)

Objective: In recent years, the use of cannabidiol in the treatment of refractory epilepsy has been increasingly investigated and has been gaining public support as a novel way to treat these disorders. Marijuana has been used for medical purposes for thousands of years, and a lot of research has been conducted over the last several decades into the chemistry and pharmacology of marijuana and its many compounds, including cannabidiol. Methods: Using PubMed, we performed a review of the literature regarding the history of cannabinoid use in treating epilepsy. Results and conclusions: There are historical and recent scientific developments that support the use of cannabidiol in rare severe epilepsy syndromes.

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If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

The Safety, Tolerability, And Effectiveness Of PTL-101, An Oral Cannabidiol Formulation, In Pediatric Intractable Epilepsy: A Phase II, Open-Label, Single-Center Study

Alexis Mitelpunkt, Uri Kramer and Moran Hausman Kedem (August 2019)

Several works have reported on the antiepileptic impact of cannabis-based preparations in patients with treatment-resistant epilepsy (TRE). However, current formulations suffer from low bioavailability and side effects. PTL-101, an oral formulation containing highly purified cannabidiol (CBD) embedded in seamless gelatin matrix beadlets was designed to enhance bioavailability and maintain a constant gastrointestinal transit time.

Important Notice

If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Cannabidiol Improves Survivability, Seizures And Associated Behavioural Comorbidities In A Range Of Animal Models Of Epilepsy

Patra, P. H. (July 2019)

Epilepsy is a chronic neurological disease characterised by recurrent seizures, premature mortality and several associated comorbidities such as motor disorder, anxiety, depression, social deficits and cognitive impairment. Here, the effect of cannabidiol (CBD) in three different preclinical models of epilepsy was investigated. First, the effect of 9-weeks oral CBD administration (200 mg/kg/day) on seizures, motor function, gait and cognition in a reduced intensity status epilepticus induced spontaneous recurrent seizures (RISE-SRS) rat model of temporal lobe epilepsy (TLE) was evaluated. Subsequently, the effect of long-term CBD administration (100 mg/kg, twice daily s.c. injections from postnatal day 8 (P8) to 25/death) on survivability and a number of welfare parameters such as natural activity, reflex/response to touch, total neonatal welfare, orbital tightening and body condition in the Scn1a-/- mouse model was investigated.

Important Notice

If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Cannabidiol Reduces Seizures Following CNS Infection With Theiler's Murine Encephalomyelitis Virus

Dipan C. Patel, Glenna Wallis, Robert S. Fujinami, Karen S. Wilcox and Misty D. Smith (July 2019)

C57BL/6J mice infected with Theiler's murine encephalomyelitis virus (TMEV) develop acute behavioral seizures in the first week of infection and later develop chronic epilepsy. The TMEV model provides a useful platform to test novel antiseizure therapeutics. The present study was designed to test the efficacy of cannabidiol (CBD) in reducing acute seizures induced by viral infection.

Important Notice

If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Dosage Related Efficacy And Tolerability Of Cannabidiol In Children With Treatment-Resistant Epileptic Encephalopathy: Preliminary Results Of The CARE-E Study

Richard J. Huntsman, Richard Tang-Wai, Jane Alcorn, Stephanie Vuong, Bryan Acton, Scott Corley, Robert B. Laprairie, Andrew W. Lyon, Simona Meier, Darrell D. Mousseau, Doris Newmeyer, Erin Prosser-Loose, Blair Seifert, Jose F. Tellez-Zenteno, Linda Huh, Edward Leung and Philippe Major (June 2019)

There is uncertainty regarding the appropriate dose of Cannabidiol (CBD) for childhood epilepsy. We present the preliminary data of seven participants from the Cannabidiol in Children with Refractory Epileptic Encephalopathy (CARE-E) study. Methods: The study is an open-label, prospective, dose-escalation trial.. The preliminary data suggest an initial CBD target dose of 5-6 mg/kg/day when a 1:20 THC:CBD CHE is used. Possible nonlinear pharmacokinetics of CBD and CBC needs investigation. The reduction in seizure frequency seen suggests improved seizure control when a whole plant CHE is used. Plasma THC levels suggest a low risk of THC intoxication when a 1:20 THC:CBD CHE is used in doses up to 12 mg/kg CBD/kg/day.

Important Notice

If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Cognitive Functioning Following Long-Term Cannabidiol Use In Adults With Treatment-Resistant Epilepsy

Roy Martin, Tyler E. Gaston, Matthew Thompson, Steve B. Ampah, Gary Cutter, E. Martina Bebin, Jerzy P. Szaflarskia (June 2019)

Cognitive dysfunction is a common comorbidity in adults with treatment-resistant epilepsy (TRE). Recently, cannabidiol (CBD) has demonstrated efficacy in epilepsy treatment. However, our understanding of CBD's cognitive effects in epilepsy is limited. We examined long-term cognitive effects of CBD in adults with TRE as part of an ongoing prospective, open-label safety study. Twenty-seven adults with TRE (mean age: 34[standard deviation (SD) + 14], female 52%) enrolled in the UAB CBD program completed standardized cognitive testing (NIH Toolbox Cognition Battery (NIHTB-CB)) at pre-CBD administration baseline and at one-year follow-up. Participants were receiving stable CBD dose at the time of one-year testing

Important Notice

If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Purified Cannabidiol For Treatment Of Refractory Epilepsies In Pediatric Patients With Developmental And Epileptic Encephalopathy

Nicola Pietrafusa, Alessandro Ferretti, Marina Trivisano, Luca de Palma, Costanza Calabrese, Giusy Carfì Pavia, Ilaria Tondo, Simona Cappelletti, Federico Vigevano and Nicola Specchi (June 2019)

A pharmaceutical grade formulation of cannabidiol (CBD) has been approved for the treatment of Dravet syndrome and Lennox-Gastaut syndrome; however, this formulation is not yet available to patients outside the USA. In addition, CBD is thought to have broad anti-seizure properties that may be beneficial for other types of intractable epilepsy.

Important Notice

If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Cannabinoid Conundrum: A Study Of Anti-Epileptic Efficacy and Drug Policy

Kennedy Dickson (May 2019)

In an effort to conduct this research, and to explore the anti-epileptic efficacy of CBD, this study utilized a zebrafish model of Dravet Syndrome. About 80% of Dravet Syndrome patients carry a mutation in the voltage-gated sodium channel Nav1.1 (scn1a). scn1a mutant zebrafish underwent both acute and subchronic exposures to various concentrations of CBD. CBD was found to significantly decrease seizure activity within the acute exposure. To provide context and relevancy to this research, the complicated legal status of marijuana is discussed, and potential reform options are provided as advocacy for policy change.

Important Notice

If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Cannabis For Refractory Epilepsy In Children: A Review Focusing On CDKL5 Deficiency Disorder

Dale, Tristan; Downs, Jenny; Olson, Heather; Bergin, Anne Marie; Smith, Stephanie; Leonard, Helen

This study provides a comprehensive overview of the potential role for cannabis in the treatment of CDD. Key areas discussed include the history, mechanism of action, efficacy and safety of cannabis based preparations as well as the burden related to CDD. The evidence supports the use of cannabinoids, especially cannabidiol, in similar forms of refractory epilepsy including Dravet and Lennox–Gastaut syndromes.

Important Notice

If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Cannabis Therapeutics And The Future of Neurology

Ethan B. Russo  (October 2018)

After elucidation of phytocannabinoid structures in the 1960s, their pharmacology was slowly revealed (reviewed by Cascio and Pertwee, 2014; Pertwee and Cascio, 2014; Russo and Marcu, 2017; Figure 1). Various components were tested for anticonvulsant activities with findings of ED50in mice of 80 mg/kg for tetrahydrocannabinol (THC), 120 mg/kg for cannabidiol (CBD) and 200 mg/kg for tetrahydrocannabinolic acid A (THCA-A), the carboxylic acid precursor to THC found in raw cannabis flowers (Karler and Turkanis, 1979). Although dose-response was tested, it is unclear that very low doses were assessed and given the biphasic tendencies of cannabinoids, it is possible that positive lower dose effects may have remained unnoticed. CBD was considered an excellent candidate for development based on its lack of untoward psychoactive sequelae.

Important Notice

If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Cannabidiol Improves Frequency And Severity Of Seizures And Reduces Adverse Events In An Open-Label Add-On Prospective Study

Jerzy P. Szaflarski, Elizabeth Martina Bebin, Gary Cutter, Jennifer DeWolfe, Leon S.Dure, Tyler E. Gaston, Pongkiat Kankirawatana, Yuliang Liu, Rani Singh, David G. Standaert, Ashley E. Thomas, Lawrence W. Ver Hoef  (August 2018)

The objective of this study was to characterize the changes in adverse events, seizure severity, and frequency in response to a pharmaceutical formulation of highly purified cannabidiol (CBD; Epidiolex®) in a large, prospective, single-center, open-label study. Of the 139 study participants in this ongoing study, at the time of analysis, 132 had 12-week, 88 had 24-week, and 61 had 48-week data. Study retention was 77% at one year. There were no significant differences between participants who contributed all 4 data points and those who contributed 2 or 3 data points in baseline demographic and AEP/SF/CSSS measures.

Important Notice

If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

A Prospective Open‐Label Trial Of A CBD/THC Cannabis Oil In Dravet Syndrome

Bláthnaid McCoy, Laura Wang, Maria Zak, Sameer Al‐Mehmadi, Nadia Kabir, Kenda Alhadid, Kyla McDonald, Grace Zhang, Rohit Sharma, Robyn Whitney, Katia Sinopoli and O. Carter Snead III  (August 2018)

Despite the expansion of available antiepileptic drugs (AED), dietary, and surgical therapies in the last 20 years, up to 30% of children with epilepsy continue to have seizures, termed drug‐resistant epilepsy. Twenty children received add‐on therapy with TIL‐TC150. The dose ranged from 2 to 16 mg/kg/day of CBD and 0.04 to 0.32 mg/kg/day of THC. Twenty children received add‐on therapy with TIL‐TC150. The dose ranged from 2 to 16 mg/kg/day of CBD and 0.04 to 0.32 mg/kg/day of THC.

Important Notice

If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Investigating The Mechanisms Of Action Of Phytocannabinoids And A Novel Cognitive Enhancer To Target The Comorbidity Of Temporal Lobe Epilepsy

Khan, Archie Arunima  (July 2018)

Temporal lobe epilepsy (TLE) is the most common type of epilepsy and exists with memory loss as a comorbidity. The conventional therapy available to treat these disorders achieves only modest therapeutic efficacy at best. This study investigates two potential treatments: phytocannabinoids to alleviate seizures, and a novel cognitive enhancer to restore/halt memory deficits.

Important Notice

If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Cannabidiol In Pediatric Epilepsy

Dallas Armstrong and Eric Marsh  (January 2018)

Cannabidiol has been well-tolerated in pediatric patients and may be an effective treatment for medically intractable epilepsy. Future studies that control for concomitant administration of clobazam and/or valproic acid are necessary.

Important Notice

If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Cannabinoids For Epilepsy: What Do We Know And Where Do We Go?

Martin J. Brodie and Elinor Ben-Menachem  (Dember 2017)

Over the past decade there has been an increasing interest in using cannabinoids to treat a range of epilepsy syndromes following reports of some remarkable responses in individual patients. The situation is complicated by the fact that these agents do not appear to work via their attachment to endogenous cannabinoid receptors. Their pharmacokinetics are complex, and bioavailability is variable, resulting in difficulty in developing a suitable formulation for oral delivery. Drug interactions also represent another complication in their everyday use.

Important Notice

If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Cannabinoids In Pediatrics

Christopher T. Campbell, PharmD; Marjorie Shaw Phillips, MS; and Kalen Manasco, PharmD  (June 2017)

Many providers have started encountering patients experimenting with cannabis products for a wide range of conditions. While the debate continues regarding these agents for both medicinal and recreational use in the general population, special consideration needs to be made for pediatric use. This review will deliver the history of marijuana use and legislation in the United States in addition to the currently available medical literature to equip pediatric health care providers with resources to provide patients and their parents the best recommendation for safe and appropriate use of cannabis-containing compounds.

Important Notice

If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Cannabinoids For Epilepsy — Real Data, At Last

Samuel F. Berkovic  (May 2017)

Medicinal cannabis is a hot-button issue in the treatment of epilepsy. The issue of its use is frequently raised in medical consultations, in the lay press, in social media, and at scientific meetings where the lack of hard data is disheartening. Anecdotal media reports of spectacular results, coupled with the allure of using a “natural” compound and long-held beliefs surrounding its recreational use, plus the fact that medicinal cannabis remains illegal in many jurisdictions, have conspired to make it extremely difficult for physicians to provide advice in this area.

Important Notice

If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Cannabinoids Therapeutic Use: What Is Our Current Understanding Following The Introduction Of THC,THC:CBD Oromucosal Spray And Others?

Mauro Maccarrone, Rafael Maldonado, Miguel Casas, Thomas Henze and Diego Centonze  (February 2017)

From the different therapeutic possibilities, THC/CBD oromucosal spray has been in clinical use for approximately five years in numerous countries world-wide for the management of multiple sclerosis (MS)-related moderate to severe resistant spasticity. Clinical trials have confirmed its efficacy and tolerability. Other diseases in which different cannabinoids are currently being investigated include various pain states, Alzheimer’s disease, Parkinson’s disease, Huntington’s disease and epilepsy. The continued characterization of individual cannabinoids in different diseases remains important.

Important Notice

If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

The Utility Of Cannabidiol In The Treatment of Refractory Epilepsy

DS Reddy  (August 2016)

Cannabis‐derived cannabinoids such as cannabidiol (CBD) have anticonvulsant properties. Recently, there has been an emerging interest in the use of CBD‐enriched products for treatment of drug‐resistant epilepsy. Some pilot trials of CBD have proved beneficial for refractory epilepsy, but its efficacy is yet to be confirmed by standard placebo‐controlled trials. However, the mechanisms underlying the seizure protection efficacy claims of CBD remain unclear. This review briefly describes the clinical utility of CBD in the treatment of refractory epilepsy.

Important Notice

If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

Cannabinoids In The Treatment Of Epilepsy

Daniel Friedman, M.D. and Orrin Devinsky, M.D.  (September 2015)

The pharmacologic and biochemical features of cannabinoids make them candidates for antiseizure medications. At this time, anecdotes have outstripped controlled clinical trials as sources of support for their clinical value.

Important Notice

If you proceed to article you will be leaving the CB1 Capital Management website to access a website hosted by a party unrelated to CB1 Capital Management. CB1 Capital Management assumes no responsibility for the accuracy of any of these studies nor does CB1 assume any obligation to update any of these studies based on subsequent research.

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