Cannabidiol (CBD) to 27 Patients (Aged 2 Years - 19 Years) With Drug Resistant Epilepsy
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|ClinicalTrials.gov Identifier: NCT02286986|
Recruitment Status : Completed
First Posted : November 10, 2014
Last Update Posted : January 27, 2020
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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.
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy||Drug: Cannabidiol||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||open label|
|Official Title:||A 2-part Study to Investigate the Dose-ranging Pharmacokinetics and Tolerability, Followed by the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With|
|Actual Study Start Date :||September 18, 2014|
|Actual Primary Completion Date :||June 13, 2019|
|Actual Study Completion Date :||June 13, 2019|
open label administration
- Seizure Frequency [ Time Frame: Baseline to 1 year ]Number of Seizures
- Drug Plasma Levels of Cannabidiol [ Time Frame: Baseline, 8 weeks, 6 months ]Lab test to check levels of steady cannabidiol use
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|Ages Eligible for Study:||2 Years to 25 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02286986
|United States, Utah|
|University of Utah School of Medicine|
|Salt Lake City, Utah, United States, 84113|
|Principal Investigator:||Francis Filloux, MD||University of Utah|
|Study Director:||Mathew Sweeney, MD||University of Utah|
|Study Director:||Colin VanOrman, MD||University of Utah|
|Responsible Party:||Francis Filloux, Francis M. Filloux, M.D. Division Chief, Pediatric Neurology University of Utah School of Medicine, University of Utah|
|Other Study ID Numbers:||
|First Posted:||November 10, 2014 Key Record Dates|
|Last Update Posted:||January 27, 2020|
|Last Verified:||January 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Medically Refractory Epilepsy
Central Nervous System Diseases
Nervous System Diseases