An Open-label Extension Trial to Investigate Possible Drug-drug Interactions Between Stiripentol or Valproate and Cannabidiol in Patients With Epilepsy

Jazz Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Epilepsy

Treatments: Drug: GWP42003-P

Study type: Interventional

Funder types: Industry

Identifiers

NCT02607904

GWEP1447 Open-label Extension

2015-002939-18 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 16 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Note: Participants who enroll in France or Sweden must be aged 18-55 years.

Key Inclusion Criteria:

• Participant must have a documented magnetic resonance imaging/computerized tomography of the brain that ruled out a progressive neurologic condition.

Key Exclusion Criteria:

• Participant has clinically significant unstable medical conditions other than epilepsy.
• 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.
• Participant is currently using felbamate and has been taking it for less than 12 months prior to screening visit of the blinded phase of the trial.
• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

GWP42003-P

Experimental group

Description:

Administered orally, twice daily (morning and evening), commencing with titration of 100 mg/mL GWP42003-P to 20 mg/kg/day over 10 days in a blinded manner (i.e., only participants taking placebo in the blinded phase will up-titrate; doses will remain unchanged for those taking GWP42003-P in the blinded phase). Participants remain on the maintenance dose for the remainder of the 48-week treatment period, until early withdrawal or at an early study conclusion date defined by the sponsor. 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.

Treatment:

Drug: GWP42003-P