Cannabidiol (CBD) to 27 Patients (Aged 2 Years - 19 Years) With Drug Resistant Epilepsy
Completed · Phase 1
Conditions studied: Epilepsy
In brief
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.
Key facts
- Study ID
- NCT02286986
- Run by
- University of Utah
- People needed
- 26
- Starts
- 2014-09-18
- Expected to finish
- 2019-06-13
- Last updated by the study team
- 2020-01-27
Who can join
Age: 2 and older, up to 25. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Utah School of Medicine — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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