A Study of GWP42006 in People With Focal Seizures - Part A

Phase 2

Completed

• Conditions: Epilepsy; Focal Seizures
• Interventions: Drug: GWP42006; Drug: Placebo

• Registration Number: NCT02369471
• Lead Sponsor: Jazz Pharmaceuticals

Brief Summary

To evaluate the pharmacokinetics, safety and tolerability of GWP42006 compared with placebo, in the presence of other antiepileptic drugs (AEDs).

Detailed Description

This is a double blind, randomized, placebo controlled, two-part study. Part A only will be described in this record.

Subjects who satisfy all inclusion and none of the exclusion criteria will begin a 14-day baseline observation period followed by a 14-day treatment period. Subjects will be required to attend six study visits. A follow-up phone call will take place four weeks after last dose.

Part A will enroll three groups of 10 subjects:

* Group 1 - subjects on inducer AEDs (and not on inhibitor AEDs)

* Group 2 - subjects on inhibitor AEDs (and not on inducer AEDs)

* Group 3 - subjects on AEDs that are neither inducers nor inhibitors.

In each of the three groups subjects will be randomized to receive, in a 4:1 ratio, GWP42006 400 mg twice daily or matching placebo. Pharmacokinetic (PK) profiles for GWP42006 and metabolites will be collected on the first and last day of treatment. Samples will also be collected 24h and 72h after the last day of treatment.

Subjects will be required to record a daily diary with information about their seizures, investigational medicinal product (IMP) and concomitant AED administration.

Study Timeline

• Study First Submitted: 2015-02-13
• Study First Submitted QC: 2015-02-20
• Study First Posted: 2015-02-24
• Study Start: 2015-03
• Primary Completion: 2015-10
• Study Completion: 2015-11
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1a	GWP42006	Subjects on inducer AEDs will administer GWP42006.
Group 2a	GWP42006	Subjects on inhibitor AEDs will administer GWP42006.
Group 3a	GWP42006	Subjects on AEDs that are neither inducers nor inhibitors will administer GWP42006.
Group 1b	Placebo	Matching placebo control for Group 1a.
Group 2b	Placebo	Matching placebo control for Group 2a.
Group 3b	Placebo	Matching placebo control for Group 3a.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters of GWP42006 and metabolites: Cmax, Cmin, tmax, AUC(0-t), AUC(0-inf) and t1/2, in the presence of other AEDs.	Day 1 to Day 18

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of GWP42006 (incidence of adverse events).	Day -14 to Day 43
The plasma concentration of concomitant AEDs.	Day 1 and Day 15