Overview

This trial is active, not recruiting.

Condition epilepsy
Treatment gwp42003-p
Phase phase 2
Sponsor GW Research Ltd
Start date January 2016
End date July 2016
Trial size 20 participants
Trial identifier NCT02564952, 2014-002942-33, GWEP1428 Open-Label Extension

Summary

This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P. However, investigators may subsequently decrease or increase the participant's dose until the optimal dose is found.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Administered orally, twice daily (morning and evening; immediately after the participant's clobazam dose), commencing with titration of 100 mg/mL GWP42003-P to 20 mg/kg/day over 10 days in a blinded manner. Participants remain on the maintenance dose for the remainder of the 12-month treatment period. However, investigators may subsequently decrease or increase the participant's dose (to a maximum of 30 mg/kg/day) until the optimum dose is found. Dosing is tapered (10% each day) for participants who do not immediately continue to use GWP42003-P once market authorization is granted, or for those who withdraw early.
gwp42003-p CBD
Yellow oily solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.

Primary Outcomes

Measure
Number of participants who experienced an adverse event.
time frame: Up to 1 year.

Secondary Outcomes

Measure
Change in serum biochemistry.
time frame: Up to 1 year.
Change in hematology.
time frame: Up to 1 year.
Change in urinalysis.
time frame: Up to 1 year.
Number of participants with a treatment-emergent suicidality flag.
time frame: Up to 1 year.
Change in vital signs.
time frame: Up to 1 year.
Number of participants with a clinically significant change in 12-lead electrocardiogram (ECG).
time frame: Up to 1 year.
Number of participants with a clinically significant change in physical examination.
time frame: Up to 1 year.
Seizure frequency by subtype.
time frame: Up to 1 year.

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Key Inclusion Criteria: - Participant must have epilepsy, as determined by the investigator, and be taking clobazam (CLB). - Participant must have a documented magnetic resonance imaging/computerized tomography of the brain ruling out a progressive neurologic condition. - Participant must be taking CLB and no more than 2 other antiepileptic drugs (AEDs) during the course of the trial. Key Exclusion Criteria: - Patient has clinically significant unstable medical conditions other than epilepsy. - Participants on CLB at doses above 20 mg per day. - Participants taking CLB intermittently as rescue medication. - Participant has a history of symptoms related to a drop in blood pressure due to postural changes (e.g., dizziness, light-headedness, blurred vision, palpitations, weakness, syncope). - Participant has any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the C-SSRS in the last month or at the screening visit of the blinded phase of the trial. - Participant has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to screening or enrollment in the blinded phase of the trial, other than epilepsy. - Participant is currently using or has in the past used recreational or medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the 3 months prior to trial entry. - Participant has any known or suspected history of any drug abuse or addiction. - Participant is unwilling to abstain from recreational or medicinal cannabis, or synthetic cannabinoid based medications (including Sativex) for the duration for the trial. - Participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the Investigational Medicinal Product (IMP), e.g., sesame oil.

Additional Information

Official title A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol (GWP42003-P)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by GW Research Ltd.