Open AccessA prospective open‐label trial of a CBD / THC cannabis oil in dravet syndrome
Author(s) -
McCoy Bláthnaid,
Wang Laura,
Zak Maria,
AlMehmadi Sameer,
Kabir Nadia,
Alhadid Kenda,
McDonald Kyla,
Zhang Grace,
Sharma Rohit,
Whitney Robyn,
Sinopoli Katia,
Snead O. Carter
Publication year - 2018
Publication title -
annals of clinical and translational neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.824
H-Index - 42
ISSN - 2328-9503
DOI - 10.1002/acn3.621
Subject(s) - cannabidiol , tolerability , medicine , dravet syndrome , adverse effect , dosing , anesthesia , elevated transaminases , somnolence , lennox–gastaut syndrome , cannabis , epilepsy , pharmacology , psychiatry
Both Δ 9 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 ‐ TC 150 ‐ 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. Methods Twenty children received add‐on therapy with TIL ‐ TC 150. 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. Results Nineteen 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 ‐ TC 150 was safe and well tolerated in our subjects. TIL ‐ TC 150 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.