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

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ClinicalTrials.gov Identifier: NCT02365610
Recruitment Status : Completed
First Posted : February 19, 2015
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
GW Research Ltd

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.


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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arm Intervention/treatment
Experimental: GWP42006
GWP42006
Drug: GWP42006
Other Names:
  • Cannabidivarin
  • CBDV

Placebo Comparator: Placebo control
Placebo
Drug: Placebo Control
Other Name: Placebo




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 ]


Information from the National Library of Medicine

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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 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.

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): NCT02365610


Locations
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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
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: NCT02365610     History of Changes
Other Study ID Numbers: GWEP1330 Part B
2014-002594-11 ( EudraCT Number )
First Posted: February 19, 2015    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
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