NCT02365610

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_2

Geographic Reach
6 countries

26 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
1 year until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

1.3 years

First QC Date

February 13, 2015

Last Update Submit

December 19, 2022

Conditions

EpilepsyFocal Seizures

Keywords

CannabidivarinCBDVGWP42006

Outcome Measures

Primary Outcomes (1)

  • Percentage change from baseline to the end of treatment in focal seizure frequency in subjects taking GWP42006 compared to placebo.

    Day -28 to Day 57

Secondary Outcomes (8)

  • Number of subjects considered treatment responders.

    Day -28 to Day 57

  • Change from baseline in seizure subtypes frequency.

    Day -28 to Day 57

  • Change from baseline in composite seizure score.

    Day -28 to Day 57

  • Change from baseline in the number of focal seizure free days.

    Day -28 to Day 57

  • Change from baseline in the usage of rescue medication.

    Day -28 to Day 57

  • +3 more secondary outcomes

Study Arms (2)

GWP42006

EXPERIMENTAL

GWP42006

Drug: GWP42006

Placebo control

PLACEBO COMPARATOR

Placebo

Drug: Placebo Control

Interventions

GWP42006DRUG
Also known as: Cannabidivarin, CBDV
GWP42006
Placebo ControlDRUG
Also known as: Placebo
Placebo control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

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

Sponsors & Collaborators

Study Sites (26)

Unknown Facility

Havířov, Czechia

Location

Unknown Facility

Hradec Králové, Czechia

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Rychnov nad Kněžnou, Czechia

Location

Unknown Facility

Budapest, Hungary

Location

Unknown Facility

Esztergom, Hungary

Location

Unknown Facility

Hódmezővásárhely, Hungary

Location

Unknown Facility

Kecskemét, Hungary

Location

Unknown Facility

Pécs, Hungary

Location

Unknown Facility

Szombathely, Hungary

Location

Unknown Facility

Bologna, Italy

Location

Unknown Facility

Pavia, Italy

Location

Unknown Facility

Rome, Italy

Location

Unknown Facility

Bydgoszcz, Poland

Location

Unknown Facility

Elblag, Poland

Location

Unknown Facility

Golub-Dobrzyń, Poland

Location

Unknown Facility

Katowice, Poland

Location

Unknown Facility

Krakow, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Wroclaw, Poland

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Birmingham, United Kingdom

Location

Unknown Facility

Glasgow, United Kingdom

Location

Unknown Facility

Great Yarmouth, United Kingdom

Location

Unknown Facility

Stoke-on-Trent, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 33998885DERIVED

MeSH Terms

Conditions

EpilepsySeizures

Interventions

cannabidivarin

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological 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 19, 2015

Study Start

March 1, 2016

Primary Completion

July 1, 2017

Study Completion

September 1, 2017

Last Updated

December 20, 2022

Record last verified: 2022-12

Locations

CZ(4)ES(2)IT(3)HU(6)GB(4)PL(7)