Cannabidiol (CBD) to 27 Patients (Aged 2 Years - 19 Years) With Drug Resistant Epilepsy
Status:
Completed
Trial end date:
2019-06-13
Target enrollment:
Participant gender:
Summary
Part A: To evaluate the safety and tolerability of multiple ascending doses of GWP42003-P
compared with placebo with respect to:
- Incidence, type and severity of adverse events (AEs)
- Effect on vital signs, including weight
- Effect on 12-lead electrocardiogram (ECG) findings
- Effect on laboratory parameters Part B: To make an assessment of the anti-epileptic
efficacy of GWP42003-P compared with placebo with respect to the incidence in convulsive
seizures
- To determine the plasma concentration time curves for GWP42003-P and its major human
metabolite, following escalating multiple doses of GWP42003-P.
- To investigate the effect of GWP42003-P on the pharmacokinetics of concomitant
anti-epileptic drugs (AEDs).
- To evaluate cognitive function, sleep quality and daytime sleepiness, in patients taking
GWP42003-P in combination with AEDs.