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

• ClinicalTrials.gov Identifier: NCT02365610
• Recruitment Status: Completed
• First Posted: February 19, 2015
• Last Update Posted: December 20, 2022
• Sponsor: Jazz Pharmaceuticals
• Information provided by (Responsible Party): Jazz Pharmaceuticals

Study Description

Brief Summary:

To investigate the potential antiepileptic effects of GWP42006 as add-on therapy in subjects with inadequately controlled focal seizures.

Condition or disease	Intervention/treatment	Phase
Epilepsy; Focal Seizures	Drug: GWP42006; Drug: Placebo Control	Phase 2

Detailed Description:

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

Subjects who satisfy all inclusion and none of the exclusion criteria will enter a four-week baseline period, followed by a two-week dose escalation period (400 mg twice daily for one week, then 600 mg twice daily for one week), a six-week stable treatment period (800 mg twice daily) and a 12-day taper period. Subjects will be required to attend eight study visits. A follow-up phone call will take place four weeks after last dose.

Subjects will be randomized to receive in a 1:1 ratio, GWP42006 or placebo. Subjects will be required to record a daily diary with information about their seizures, investigational medicinal product (IMP) and concomitant antiepileptic drug (AED) administration.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 162 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Double Blind, Randomized, Placebo-controlled, Two-part Study to Investigate the Pharmacokinetics, Followed by Efficacy and Safety of GWP42006 as add-on Therapy in Patients With Inadequately Controlled Focal Seizures.
• Actual Study Start Date: March 2016
• Actual Primary Completion Date: July 2017
• Actual Study Completion Date: September 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: GWP42006; GWP42006	Drug: GWP42006; Other Names: Cannabidivarin; CBDV
Placebo Comparator: Placebo control; Placebo	Drug: Placebo Control; Other Name: Placebo

Outcome Measures

Primary Outcome Measures :

1. Percentage change from baseline to the end of treatment in focal seizure frequency in subjects taking GWP42006 compared to placebo. [ Time Frame: Day -28 to Day 57 ]

Secondary Outcome Measures :

1. Number of subjects considered treatment responders. [ Time Frame: Day -28 to Day 57 ]
2. Change from baseline in seizure subtypes frequency. [ Time Frame: Day -28 to Day 57 ]
3. Change from baseline in composite seizure score. [ Time Frame: Day -28 to Day 57 ]
4. Change from baseline in the number of focal seizure free days. [ Time Frame: Day -28 to Day 57 ]
5. Change from baseline in the usage of rescue medication. [ Time Frame: Day -28 to Day 57 ]
6. Subject Global Impression of Change (SGIC). [ Time Frame: Day 57 ]
7. Physician Global Impression of Change (PGIC) at the end of treatment. [ Time Frame: Day 57 ]
8. The incidence of adverse events as a measure of subject safety. [ Time Frame: Day -28 to Day 96 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

For inclusion in Part B 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, 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.
• All medications or interventions for epilepsy (including ketogenic diet) must have been stable for one month prior to screening and the subject 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 B of the study if ANY of the following apply:

• Time of onset of focal epilepsy treatment is less than two years prior to enrolment.
• Patient has seizures that are not of focal onset.
• Patient only has focal seizures without impairment of consciousness or awareness and without an observable motor component (even if autonomic component is present).
• Episode(s) of status epilepticus during one year prior to screening.
• History of pseudo-seizures.
• Vagus Nerve Stimulation, Deep Brain Stimulation, Responsive Neurostimulator System or other epilepsy neurostimulation device have been implanted or activated less than one year prior to screening, and/or stimulation parameters have been stable for less than one month, and/or battery life of unit not anticipated to extend for duration of trial.
• Had epilepsy surgery within one year of screening.
• 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 B2 and B7.
• 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.

Contacts and Locations

Locations

Czechia

Havířov, Czechia

Hradec Králové, Czechia

Praha, Czechia

Rychnov nad Kněžnou, Czechia

Hungary

Budapest, Hungary

Esztergom, Hungary

Hodmezovasarhely, Hungary

Kecskemét, Hungary

Pecs, Hungary

Szombathely, Hungary

Italy

Bologna, Italy

Pavia, Italy

Rome, Italy

Poland

Bydgoszcz, Poland

Elbląg, Poland

Golub-Dobrzyn, Poland

Katowice, Poland

Krakow, Poland

Kraków, Poland

Warszawa, Poland

Wrocław, Poland

Spain

Barcelona, Spain

Madrid, Spain

United Kingdom

Birmingham, United Kingdom

Glasgow, United Kingdom

Great Yarmouth, United Kingdom

Stoke-on-Trent, United Kingdom

Sponsors and Collaborators

Jazz Pharmaceuticals

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Brodie MJ, Czapinski P, Pazdera L, Sander JW, Toledo M, Napoles M, Sahebkar F, Schreiber A; GWEP1330 Study Group. A Phase 2 Randomized Controlled Trial of the Efficacy and Safety of Cannabidivarin as Add-on Therapy in Participants with Inadequately Controlled Focal Seizures. Cannabis Cannabinoid Res. 2021 Dec;6(6):528-536. doi: 10.1089/can.2020.0075. Epub 2021 Feb 15.

• Responsible Party: Jazz Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02365610
• Other Study ID Numbers: GWEP1330 Part B; 2014-002594-11 ( EudraCT Number )
• First Posted: February 19, 2015
• Last Update Posted: December 20, 2022
• Last Verified: December 2022

Keywords provided by Jazz Pharmaceuticals:

Cannabidivarin; CBDV; GWP42006

Additional relevant MeSH terms:

Seizures; Nervous System Diseases; Neurologic Manifestations