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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02286986
Recruitment Status : Active, not recruiting
First Posted : November 10, 2014
Last Update Posted : July 19, 2018
Information provided by (Responsible Party):
Francis Filloux, University of Utah

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 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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: open label
Primary Purpose: Treatment
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
Study Start Date : September 2014
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
open label administration
Drug: Cannabidiol

Primary Outcome Measures :
  1. Seizure Frequency [ Time Frame: Baseline to 1 year ]
    Number of Seizures

Secondary Outcome Measures :
  1. Drug Plasma Levels of Cannabidiol [ Time Frame: Baseline, 8 weeks, 6 months ]
    Lab test to check levels of steady cannabidiol use

Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02286986

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United States, Utah
University of Utah School of Medicine
Salt Lake City, Utah, United States, 84113
Sponsors and Collaborators
University of Utah
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Principal Investigator: Francis Filloux, MD University of Utah
Study Director: Mathew Sweeney, MD University of Utah
Study Director: Colin VanOrman, MD University of Utah

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Responsible Party: Francis Filloux, Francis M. Filloux, M.D. Division Chief, Pediatric Neurology University of Utah School of Medicine, University of Utah Identifier: NCT02286986     History of Changes
Other Study ID Numbers: IND 70871
First Posted: November 10, 2014    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Francis Filloux, University of Utah:
Dravet syndrome
Intractable Epilepsy
Medically Refractory Epilepsy
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases