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

NCT02607904 | Completed Phase 2

• 2 other identifiers: GWEP1447 Open-label Extension2015-002939-18
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 5

Brief 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.

Conditions

Epilepsy

Keywords

Cannabidiol; GWP42003-P; Epidiolex; Stiripentol; Valproate

Outcome Measures

Primary Outcomes (1)

• Number of participants who experienced an adverse event.

  The number of participants who experienced an adverse event during the trial is presented.

  Up to 48 weeks.

Secondary Outcomes (9)

• Number of participants with a clinically significant change in 12-lead electrocardiogram (ECG).

  Up to 48 weeks.

• Number of participants with a clinically significant change in serum biochemistry.

  Up to 48 weeks.

• Number of participants with a clinically significant change in hematology.

  Up to 48 weeks.

• Number of participants with a clinically significant change in urinalysis.

  Up to 48 weeks.

• Number of participants with a clinically significant change in vital signs.

  Up to 48 weeks.

Study Arms (1)

GWP42003-P

EXPERIMENTAL

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.

Drug: GWP42003-P

Interventions

GWP42003-P DRUG

Clear, colorless to yellow solution containing cannabidiol (CBD) dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.

Also known as: Cannabidiol, CBD, Epidiolex

GWP42003-P

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (5)

SEIN - Epilepsy Institute in the Netherlands Foundation

Zwolle, Netherlands

Location

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Location

Hospital Ruber Internacional

Madrid, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, Spain

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 18, 2015
• Study Start: December 15, 2016
• Primary Completion: May 27, 2019
• Study Completion: May 27, 2019
• Last Updated: December 20, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); SE (1); NL (1)