Clinical trial NCT02607904: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Epilepsy
Keywords: Cannabidiol
GWP42003-P
Epidiolex
Stiripentol
Valproate
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of participants who experienced an adverse event.
timeFrame: Up to 48 weeks.
Secondary outcomes:
measure: Number of participants with a clinically significant change in 12-lead electrocardiogram (ECG).
timeFrame: Up to 48 weeks.
measure: Number of participants with a clinically significant change in serum biochemistry.
timeFrame: Up to 48 weeks.
measure: Number of participants with a clinically significant change in hematology.
timeFrame: Up to 48 weeks.
measure: Number of participants with a clinically significant change in urinalysis.
timeFrame: Up to 48 weeks.
measure: Number of participants with a clinically significant change in vital signs.
timeFrame: Up to 48 weeks.
measure: Number of participants with a clinically significant change in physical examination.
timeFrame: Up to 48 weeks.
measure: Number of participants with a treatment-emergent suicidality flag.
timeFrame: Up to 48 weeks.
measure: Seizure frequency by subtype.
timeFrame: Up to 48 weeks.
measure: Number of participants with a treatment-emergent finding indicative of drug abuse liability.
timeFrame: Up to 48 weeks.
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: SEIN - Epilepsy Institute in the Netherlands Foundation
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Ruber Internacional
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Göteborg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
References: