Epilepsy is a central nervous system disorder characterized by uncontrollable twitching of the arms or legs and/or seizures. One in 26 Americans will develop epilepsy during their lifetime, according to statistics published by The Epilepsy Foundation. Conventional treatment to mitigate symptoms of this disorder includes medications or sometimes surgery. Nonetheless, even with conventional treatment, an estimated 30 percent of people with epilepsy continue to experience seizures.
Despite anecdotal reports of cannabis alleviating epileptic symptoms, placebo-controlled clinical data establishing cannabinoids’ efficacy for this condition in adults largely remains lacking.[1] However, in recent years, clinicians have begun to focus specifically on the ability of cannabidiol to potentially mitigate symptoms associated with intractable pediatric epilepsy.
Media reports regarding the successful use of CBD by pediatric patients are widespread.[2] Parents of children with severe epilepsy have also reported successful experiences with cannabidiol-enriched cannabis in scientific surveys.[3-4]
Recently published observational data is also supportive of CBD’s anti-seizure activity in adolescent patients. For example, a retrospective chart review of children and adolescents who were given oral cannabis extracts in a Colorado epilepsy center reported some mitigation in seizure frequency in up to 57 percent of subjects.[5] Additional benefits reported included: improved behavior/alertness (33 percent), improved language (10 percent), and improved motor skills (10 percent).
In the fall of 2013, the United States Food and Drug Administration granted orphan drug status to imported, pharmaceutically standardized CBD (aka Epidiolex) extracts for use in experimental pediatric treatment. Clinical trials assessing the safety and efficacy of the treatment in children with severe forms of the disease, such as Dravet syndrome, began in 2014.[6] At present, a consortium of 10 epilepsy centers is collecting prospective data on children and young adults prescribed Epidiolex.[7] Clinical trial results publicized in April 2015 at the 67th Annual Meeting of the American Academy of Neurology reported that the administration of these extracts decreased seizure frequency by 54 percent over a 12-week period in children with treatment-resistant epilepsy.[8] Separate observational data reports that 70 percent children administered Epidiolex adjunctively with clobazam experience a greater than 50 percent decrease in seizure frequency. “CBD is a safe and effective treatment of refractory epilepsy in patients receiving CLB treatment,” authors reported.[9] Additional clinical trials of Epidiolex, along with several state-sponsored trials using CBD extracts, are ongoing. In 2014, the Epilepsy Foundation of America resolved for “changes to state laws to increase access to medical marijuana as a treatment option for epilepsy, including pediatric use as supported by a treating physician.”[10]
REFERENCES
[1] Editorial. 2012. Marijuana for epilepsy: winds of change. Epilepsy & Behavior 29: 435-436
[2] Saundra Young, CNN.com. August 7, 2013. “Marijuana stops child’s severe seizures.”
[3] Porter and Jacobson. 2013. Report of a parnet survey of cannabidiol-enriched cannabis use in pediatric treatment-resistant epilepsy. Epilepsy & Behavior 29: 574-577.
[4] Hussain et al. 2015. Perceived efficacy of cannabidiol-enriched cannabis extracts for treatment of pediatric epilepsy: A potential role for infantile spasms and Lennox-Gastaut syndrome. Epilepsy & Behavior 47: 138-141.
[5] Press et al. 2015. Parental reporting of response to oral cannabis extracts for treatment of refractory epilepsy.Epilepsy & Behavior 45: 49-52.
[6] Susan Livio, New Jersey Star-Ledger. December 6, 2013. FDA-approved medical marijuana clinical trial gets underway next month for kids with epilepsy.
[7] Friendman and Devinsky. 2015. Cannabinoids in the treatment of epilepsy. New England Journal of Medicine373: 1048-1058.
[8] American Academy of Neurology press release, “Medical marijuana liquid extract may bring hope for children with severe epilepsy,” April 13, 2015.
[9] Geffrey et al. 2015. Drug–drug interaction between clobazam and cannabidiol in children with refractory epilepsy. Epilepsia 56: 1246-1251.
[10] Epilepsy Foundation of America press release, “Epilepsy Foundation calls for increased medical marijuana access and research,” February 20, 2014.
A 98 percent purified CBD extract product, Epidiolex.
GW Pharmaceuticals recently announced a pivotal study The Phase III study found that Epidiolex reduces seizures by 39 percent compared to 13 percent with a placebo. Only one more step remains, a Phase IV study scheduled for release this year. 2016
The research treated children, with an average age of 10 years old, who suffered from a severe form of epilepsy, with researchers looking at 120 participants for a period of 14 weeks. Participants took an average dose of 5-mg per day and increased dosage until they achieved desired results. The company is also looking into treatments for Lennox-Gestaut Syndrome and Tuberous Sclerosis. GW Pharmaceutical’s other product, Sativex, is approved in 20 countries;