The goal of this study was to establish dosage and tolerability of TIL-TC150 in children with Dravet syndrome. TIL-TC150 is a drug is produced by Tilray containing 100 mg/mL CBD and 2mg/mL THC. The study evaluated quality of life, impact on seizures and EEG results.
Nineteen children received the TIL-TC150 in dosages ranging from 2 to 16 mg/kg/day of CBD and 0.04 to 0.32 mg/kg/day of THC for a period of 20 weeks with an increase in dosage each week. The patients were monitored during this time period to determine tolerability, favorable results and adverse effects.
The mean dosage for patients during the 20 week period was 13.3 mg/kg/day of CBD and 0.27 mg/kg/day of THC. The patients reported that there was a significant improvement in quality of life, reduction in EEG spike activity and a seizure reduction of 70.6%. Adverse effects reported were sleepiness, anorexia and diarrhea.
Overall, TIL-TC150 was safe and well-tolerated by patients. This treatment resulted in a reduction of seizures, decline in EEG spike activity and improved quality of life measures. This study has provided a standard for safety and dosing information for CBD containing minimal amounts of THC.
To review the original medical study, please see the link here.