INTERVENTIONALCOMPLETEDNCT02607891

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

This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The blinded phase only will be described in this record. Participants will be randomized in a 4:1 ratio to receive GWP42003-P or matching placebo. The hypothesis is that levels of stiripentol (STP) or valproate (VPA) may be altered (increased or decreased) as a result of using GWP42003-P.

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2022-12-20

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE2
Enrollment: 35 (ACTUAL)
Start date: 2016-11-09
Sponsor: Jazz Pharmaceuticals
Design: RANDOMIZED · PARALLEL · TREATMENT
Locations: 5
Results record: Not present in registry snapshot

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Interventions

What was registered

DRUG

GWP42003-P

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

Cannabidiol · CBD · Epidiolex

DRUG

Placebo

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

Eligibility

Population and criteria

Sex: ALL
Minimum age: 16 Years
Maximum age: 55 Years
Healthy volunteers: Not accepted

Eligibility criteria

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

Inclusion criteria

Participant must be taking STP (for the STP arm) or VPA (for the VPA arm) and no more than 2 other antiepileptic drugs (AEDs) during the blinded period of the trial.
In the VPA arm only, the participant must not be receiving STP (VPA allowed in STP arm).
AED doses, including STP or VPA, must be stable for 4 weeks prior to screening and regimen must remain stable throughout the duration of the blinded period of the trial.
Participant must have a documented magnetic resonance imaging/computerized tomography of the brain that ruled out a progressive neurologic condition.
Participant must have experienced at least 1 countable uncontrolled seizure of any type (i.e., tonic-clonic, tonic, clonic, atonic, partial onset or focal: focal seizures with retained consciousness and a motor component, focal seizures with impaired consciousness, focal seizures evolving to bilateral secondary generalization) within 2 months prior to randomization.
Intervention with vagus nerve stimulation and/or ketogenic diet must be stable for 4 weeks prior to baseline and the participant must be willing to maintain a stable regimen during the blinded period of the trial.
Participant must abstain from alcohol during the blinded period of the trial.

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 a QT interval, corrected for heart rate with Bazett's formula (QTcB), greater than:
450 msec for males.
470 msec for females.
480 msec if right bundle branch block is present.
Participant has any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the C-SSRS in the last month or at screening.
Participant has had clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to screening or enrollment, other than epilepsy.

primary outcomes

primary measures

Maximum plasma concentration (Cmax) of STP, VPA, cannabidiol (CBD).

Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.

The Cmax of STP, VPA and CBD is presented.

Time to the maximum plasma concentration (Tmax) of STP, VPA and CBD.

Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.

The Tmax of STP, VPA and CBD is presented.

Area under the curve (AUC) from zero to final time of positive detection (0-t) of STP, VPA and CBD.

Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.

The AUC(0-t) of STP, VPA and CBD is presented.

Area under the plasma concentration time curve over a dosing interval, where tau is the dosing interval [AUCtau].

Time frame: 0, 0.25, 0.5, 1, 1.5, 2, 4, 6, and 12 hours post-dose.

The AUC(tau) of STP, VPA, and CBD is presented.

secondary outcomes

secondary measures