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

NCT02369471 | Completed Phase 2 DMC

• 2 other identifiers: GWEP1330 Part A2014-002594-11
• Study Type: interventional
• Target: 32
• Locations: 3 countries
• Sites: 9

Brief Summary

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

Conditions

Epilepsy; Focal Seizures

Keywords

Cannabidivarin; CBDV; GWP42006

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (6)

Group 1a

EXPERIMENTAL

Subjects on inducer AEDs will administer GWP42006.

Drug: GWP42006

Group 2a

ACTIVE COMPARATOR

Subjects on inhibitor AEDs will administer GWP42006.

Drug: GWP42006

Group 3a

EXPERIMENTAL

Subjects on AEDs that are neither inducers nor inhibitors will administer GWP42006.

Drug: GWP42006

Group 1b

PLACEBO COMPARATOR

Matching placebo control for Group 1a.

Drug: Placebo

Group 2b

PLACEBO COMPARATOR

Matching placebo control for Group 2a.

Drug: Placebo

Group 3b

PLACEBO COMPARATOR

Matching placebo control for Group 3a.

Drug: Placebo

Interventions

GWP42006 DRUG

Also known as: Cannabidivarin, CBDV

Group 1a; Group 2a; Group 3a

Placebo DRUG

Group 1b; Group 2b; Group 3b

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

For inclusion in Part A of the study patients must fulfil ALL of the following criteria: * Male or female aged between 18 and 65 years, inclusive. * Well-documented history of focal epilepsy, with focal seizures as the primary seizure type, compatible electroencephalogram and clinical history. * Documented computerized tomography / magnetic resonance imaging that shows no progressive neurologic abnormality. * Has focal seizures despite prior treatment with at least two AEDs (whether as monotherapies or in combination). * Currently treated with one to three AEDs as follows: * Group 1 - subjects on inducer AEDs (and not on inhibitor AEDs) * Group 2 - subjects on inhibitor AEDs (and no on inducer AEDs) * Group 3 - subjects on AEDs that are neither inducers nor inhibitors. * All medications or interventions for epilepsy (including ketogenic diet and any neurostimulation devices for epilepsy) must have been stable for two weeks prior to screening and the patient is willing to maintain a stable regimen throughout the study. * Subject is willing to keep any factors expected to affect seizures stable (such as the level of alcohol consumption and smoking). The patient may not enter Part A of the study if ANY of the following apply: * Time of onset of epilepsy treatment is less than two years prior to enrolment. * Episode(s) of status epilepticus during one year prior to screening. * History of pseudo-seizures. * Subject has clinically significant unstable medical conditions other than epilepsy. * Subject has an illness in the four weeks prior to screening or randomization, other than epilepsy, which in the opinion of the investigator would affect seizure frequency. * Subject has significantly impaired hepatic function at Visit 1. * Active suicidal plan/intent in the past six months, or a history of suicide attempt in the last two years, or more than one lifetime suicide attempt. * Subject is currently using or has in the past used recreational or medicinal cannabis, or cannabinoid based medications within the three months prior to screening and is unwilling to abstain for the duration for the study. * Subject has taken St John's Wort in the last two weeks and/or is unwilling to abstain throughout the study. * Subject has consumed grapefruit or grapefruit juice three days prior to randomization and/or unwilling to abstain in the three days prior to Visits A2 and A4. * Any known or suspected hypersensitivity to cannabinoids, sesame oil or any of the excipients of the IMP(s). * Subjects who have received an IMP within the 12 weeks prior to the screening visit.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (9)

Unknown Facility

Havířov, Czechia

Location

Unknown Facility

Hradec Králové, Czechia

Location

Unknown Facility

Rychnov nad Kněžnou, Czechia

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Birmingham, United Kingdom

Location

Unknown Facility

Dundee, United Kingdom

Location

Unknown Facility

Glasgow, United Kingdom

Location

Unknown Facility

Great Yarmouth, United Kingdom

Location

Unknown Facility

Stoke-on-Trent, United Kingdom

Location

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

cannabidivarin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: February 24, 2015
• Study Start: March 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 20, 2022

Record last verified: 2022-12

Locations

ES (1); CZ (3); GB (5)