Status:
COMPLETED
Cannabidiol (CBD) to 27 Patients (Aged 2 Years - 19 Years) With Drug Resistant Epilepsy
Lead Sponsor:
University of Utah
Conditions:
Epilepsy
Eligibility:
All Genders
2-25 years
Phase:
PHASE1
Brief 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 vit...
Detailed Description
This multi-center study will consist of two parts: Part A and Part B. Part A will investigate the dose-ranging pharmacokinetics and tolerability of GWP42003-P. Part B is a 1:1 randomized, placebo-con...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 18 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2019
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT02286986
Start Date
September 18 2014
End Date
June 13 2019
Last Update
January 27 2020
Active Locations (1)
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1
University of Utah School of Medicine
Salt Lake City, Utah, United States, 84113