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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02369471
Recruitment Status : Completed
First Posted : February 24, 2015
Last Update Posted : June 6, 2016
Sponsor:
Information provided by (Responsible Party):
GW Research Ltd

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

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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 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.
Study Start Date : March 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arm Intervention/treatment
Experimental: Group 1a
Subjects on inducer AEDs will administer GWP42006.
Drug: GWP42006
Other Names:
  • Cannabidivarin
  • CBDV

Active Comparator: Group 2a
Subjects on inhibitor AEDs will administer GWP42006.
Drug: GWP42006
Other Names:
  • Cannabidivarin
  • CBDV

Experimental: Group 3a
Subjects on AEDs that are neither inducers nor inhibitors will administer GWP42006.
Drug: GWP42006
Other Names:
  • Cannabidivarin
  • CBDV

Placebo Comparator: Group 1b
Matching placebo control for Group 1a.
Drug: Placebo
Placebo Comparator: Group 2b
Matching placebo control for Group 2a.
Drug: Placebo
Placebo Comparator: Group 3b
Matching placebo control for Group 3a.
Drug: Placebo



Primary Outcome Measures :
  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. [ Time Frame: Day 1 to Day 18 ]

Secondary Outcome Measures :
  1. Safety and tolerability of GWP42006 (incidence of adverse events). [ Time Frame: Day -14 to Day 43 ]
  2. The plasma concentration of concomitant AEDs. [ Time Frame: Day 1 and Day 15 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02369471


Locations
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Czech Republic
Havířov, Czech Republic
Hradec Králové, Czech Republic
Rychnov nad Kněžnou, Czech Republic
Spain
Barcelona, Spain
United Kingdom
Birmingham, United Kingdom
Dundee, United Kingdom
Glasgow, United Kingdom
Great Yarmouth, United Kingdom
Stoke-on-Trent, United Kingdom
Sponsors and Collaborators
GW Research Ltd
Investigators
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Principal Investigator: Josemir W Sander, MD PhD FRCP NIRH University College London

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Responsible Party: GW Research Ltd
ClinicalTrials.gov Identifier: NCT02369471    
Other Study ID Numbers: GWEP1330 Part A
2014-002594-11 ( EudraCT Number )
First Posted: February 24, 2015    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: June 2016
Keywords provided by GW Research Ltd:
Cannabidivarin
CBDV
GWP42006
Additional relevant MeSH terms:
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Seizures
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms