A prospective open‐label trial of a CBD/THC cannabis oil in dravet syndrome

Abstract

IntroductionBoth Δ9 Tetrahydrocannabidiol (THC) and cannabidiol (CBD) components of cannabis, have been shown to have anticonvulsant effects. Cannabis oils are used to treat seizures in drug‐resistant epilepsy (DRE). Recent trials provide data on dosing, side effects, and efficacy of CBD, yet there is a paucity of information on THC in epilepsy. Primary objective was to establish dosing and tolerability of TIL‐TC150 ‐ a cannabis plant extract produced by Tilray®, containing 100 mg/mL CBD and 2 mg/mL THC‐ in children with Dravet syndrome. Secondary objectives were to assess impact of therapy on seizures, electroencephalogram (EEG) and quality of life.MethodsTwenty 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. Patients were monitored for tolerability and adverse events, and secondary objectives.ResultsNineteen participants completed the 20‐week intervention. Mean dose achieved was 13.3 mg/kg/day of CBD (range 7–16 mg/kg/day) and 0.27 mg/kg/day of THC (range 0.14–0.32 mg/kg/day). Adverse events, common during titration included somnolence, anorexia, and diarrhea. Abnormalities of liver transaminases and platelets were observed with concomitant valproic acid therapy. There was a statistically significant improvement in quality of life, reduction in EEG spike activity, and median motor seizure reduction of 70.6%, with 50% responder rate of 63%.Conclusions TIL‐TC150 was safe and well tolerated in our subjects. TIL‐TC150 treatment resulted in a reduction in seizure counts, spike index on EEG, and improved quality of life measures. This study provides safety and dosing information for THC‐containing cannabinoid preparations.

Dravet syndrome: Treatment options and management of prolonged seizures

“…There also remains the question as to whether additional benefit may be gained with inclusion of some THC; there is much professional concern about the lack of knowledge about ongoing safety of inclusion of THC, and therefore there would be an advantage to the knowledge of whether additional benefit could be gained or whether CBD alone gives maximal benefit. There is a single report of an open label study utilizing CBD with 2% THC from Canada in 20 children with DS . The dose ranged from 2 to 16 mg/kg/d of CBD and from 0.04 to 0.32 mg/kg/d of THC.…”

Cannabis for Pediatric and Adult Epilepsy

“…The CHE also resulted in improvements in quality of life measures and spike index on electroencephalogram (EEG). Adverse events during the titration period included somnolence, anorexia and diarrhea [63].…”

Cannabidiol is beneficial in management of drug-resistant Dravet syndrome

“…References were also reviewed in articles on cannabidiol use in Dravet syndrome on UpToDate. This searc h resulted in sixty nine articles, with eleven specifically focusing on Dravet syndrome and cannabidiol therapy: three clinical trials with human subjects 2,3,4 , one clinical trial with a mouse model 5 , five commentaries [6][7][8][9][10] , one review 11 , and one case report. 12 The review ISSN: 2379-4550 http://digitalcommons.wayne.edu/crp, © 2019 The Author(s) 2…”

“…3 In addition, another clinical trial considered use of THC combined with CBD in treatment of Dravet syndrome. 2 The final clinical trial with human subjects is newly published. 4 The case report focused on successful use of cannabidiol in one patient.…”