Cannabidiol (CBD) to 27 Patients (Aged 2 Years - 19 Years) With Drug Resistant Epilepsy

• Status: Completed
• Trial end date: 2019-06-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Treatments: Cannabidiol

Criteria

Inclusion Criteria:Patients meeting the following criteria will be considered eligible for this study:

• Documentation of a diagnosis of drug resistant epilepsy as evidenced by failure to control siezures despite appropriate trial of four or more Anti-Epileptic Drugs at therapeutic doses. Documentation must include the diagnosis of epilepsy type or epilepsy syndrome (if possible), as well as the underlying case, when known.

• Between 1-3 baseline anti-epileptic drugs at stable doses for a minimum of 4 weeks prior to enrollment. Vagus nerve stimulator, ketogenic diet and modified Atkins diet do not count toward this limit.

• Vagus nerve stimulator must be on stable settings for a minimum of 3 months.

• Written informed consent obtained from the patient or the patient's legal representative must be obtained prior to beginning treatment.

Exclusion Criteria:Exclusion: The patient may not enter the study if ANY of the following apply:

• Treatment with any artisanal preparation containing or possible containing CBD during the month before initiation of the study drug.