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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02607904
• Other study ID #: GWEP1447 Open-label Extension
• Secondary ID: 2015-002939-18
• Status: Completed
• Phase: Phase 2
• Start date: December 15, 2016
• Est. completion date: May 27, 2019

Study information

• Verified date: December 2022
• Source: Jazz Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 27, 2019
• Est. primary completion date: May 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• GWP42003-P
Clear, colorless to yellow solution containing cannabidiol (CBD) dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.

Locations

Country	Name	City	State
Netherlands	SEIN - Epilepsy Institute in the Netherlands Foundation	Zwolle
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Ruber Internacional	Madrid
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Sweden	Sahlgrenska University Hospital	Göteborg

Sponsors (1)

Lead Sponsor	Collaborator
Jazz Pharmaceuticals

Countries where clinical trial is conducted

Netherlands,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to 48 weeks.
Secondary	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.	Up to 48 weeks.
Secondary	Number of participants with a clinically significant change in hematology.	The number of participants with a clinically significant change in hematology is presented.	Up to 48 weeks.
Secondary	Number of participants with a clinically significant change in urinalysis.	The number of participants with a clinically significant change in urinalysis is presented.	Up to 48 weeks.
Secondary	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.	Up to 48 weeks.
Secondary	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.	Up to 48 weeks.
Secondary	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.	Up to 48 weeks.
Secondary	Seizure frequency by subtype.	The frequency of each subtype of seizure at baseline and end of treatment is presented.	Up to 48 weeks.
Secondary	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.	Up to 48 weeks.