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

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GWP42003-P
Sponsored by
Jazz Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Cannabidiol, GWP42003-P, Epidiolex, Stiripentol, Valproate

Eligibility Criteria

16 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • SEIN - Epilepsy Institute in the Netherlands Foundation
  • Hospital Universitari Vall d'Hebron
  • Hospital Ruber Internacional
  • Hospital Universitario Virgen del Rocio
  • Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GWP42003-P

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of participants with a clinically significant change in 12-lead electrocardiogram (ECG).
The number of participants with a clinically significant change in ECG is presented.
Number of participants with a clinically significant change in serum biochemistry.
The number of participants with a clinically significant change in serum biochemistry is presented.
Number of participants with a clinically significant change in hematology.
The number of participants with a clinically significant change in hematology is presented.
Number of participants with a clinically significant change in urinalysis.
The number of participants with a clinically significant change in urinalysis is presented.
Number of participants with a clinically significant change in vital signs.
The number of participants with a clinically significant change in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate) is presented.
Number of participants with a clinically significant change in physical examination.
The number of participants with a clinically significant change in physical examination is presented.
Number of participants with a treatment-emergent suicidality flag.
Suicidality was assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS). The number of participants with a treatment-emergent flag is presented.
Seizure frequency by subtype.
The frequency of each subtype of seizure at baseline and end of treatment is presented.
Number of participants with a treatment-emergent finding indicative of drug abuse liability.
Abuse liability was assessed through monitoring of triggering adverse events of interest and study medication accountability discrepancies. Any findings were assigned to an appropriate classification by the investigator. The number of participants with a treatment-emergent finding indicative of drug abuse liability is presented.

Full Information

First Posted
November 16, 2015
Last Updated
December 19, 2022
Sponsor
Jazz Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02607904
Brief Title
An Open-label Extension Trial to Investigate Possible Drug-drug Interactions Between Stiripentol or Valproate and Cannabidiol in Patients With Epilepsy
Official Title
A Phase 2, Double-blind, Randomized, Placebo-controlled Pharmacokinetic Trial in 2 Parallel Groups to Investigate Possible Drug-drug Interactions Between Stiripentol or Valproate and GWP42003-P in Patients With Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 15, 2016 (Actual)
Primary Completion Date
May 27, 2019 (Actual)
Study Completion Date
May 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jazz Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Cannabidiol, GWP42003-P, Epidiolex, Stiripentol, Valproate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GWP42003-P
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
GWP42003-P
Other Intervention Name(s)
Cannabidiol, CBD, Epidiolex
Intervention Description
Clear, colorless to yellow solution containing cannabidiol (CBD) dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Primary Outcome Measure Information:
Title
Number of participants who experienced an adverse event.
Description
The number of participants who experienced an adverse event during the trial is presented.
Time Frame
Up to 48 weeks.
Secondary Outcome Measure Information:
Title
Number of participants with a clinically significant change in 12-lead electrocardiogram (ECG).
Description
The number of participants with a clinically significant change in ECG is presented.
Time Frame
Up to 48 weeks.
Title
Number of participants with a clinically significant change in serum biochemistry.
Description
The number of participants with a clinically significant change in serum biochemistry is presented.
Time Frame
Up to 48 weeks.
Title
Number of participants with a clinically significant change in hematology.
Description
The number of participants with a clinically significant change in hematology is presented.
Time Frame
Up to 48 weeks.
Title
Number of participants with a clinically significant change in urinalysis.
Description
The number of participants with a clinically significant change in urinalysis is presented.
Time Frame
Up to 48 weeks.
Title
Number of participants with a clinically significant change in vital signs.
Description
The number of participants with a clinically significant change in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate) is presented.
Time Frame
Up to 48 weeks.
Title
Number of participants with a clinically significant change in physical examination.
Description
The number of participants with a clinically significant change in physical examination is presented.
Time Frame
Up to 48 weeks.
Title
Number of participants with a treatment-emergent suicidality flag.
Description
Suicidality was assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS). The number of participants with a treatment-emergent flag is presented.
Time Frame
Up to 48 weeks.
Title
Seizure frequency by subtype.
Description
The frequency of each subtype of seizure at baseline and end of treatment is presented.
Time Frame
Up to 48 weeks.
Title
Number of participants with a treatment-emergent finding indicative of drug abuse liability.
Description
Abuse liability was assessed through monitoring of triggering adverse events of interest and study medication accountability discrepancies. Any findings were assigned to an appropriate classification by the investigator. The number of participants with a treatment-emergent finding indicative of drug abuse liability is presented.
Time Frame
Up to 48 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
SEIN - Epilepsy Institute in the Netherlands Foundation
City
Zwolle
Country
Netherlands
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
Country
Spain
Facility Name
Hospital Ruber Internacional
City
Madrid
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
Country
Spain
Facility Name
Sahlgrenska University Hospital
City
Göteborg
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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