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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

Tracking Information
First Submitted Date  ICMJE February 13, 2015
First Posted Date  ICMJE February 19, 2015
Last Update Posted Date December 20, 2017
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02365610 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2015)
  • Number of subjects considered treatment responders. [ Time Frame: Day -28 to Day 57 ]
  • Change from baseline in seizure subtypes frequency. [ Time Frame: Day -28 to Day 57 ]
  • Change from baseline in composite seizure score. [ Time Frame: Day -28 to Day 57 ]
  • Change from baseline in the number of focal seizure free days. [ Time Frame: Day -28 to Day 57 ]
  • Change from baseline in the usage of rescue medication. [ Time Frame: Day -28 to Day 57 ]
  • Subject Global Impression of Change (SGIC). [ Time Frame: Day 57 ]
  • Physician Global Impression of Change (PGIC) at the end of treatment. [ Time Frame: Day 57 ]
  • The incidence of adverse events as a measure of subject safety. [ Time Frame: Day -28 to Day 96 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of GWP42006 in People With Focal Seizures - Part B
Official Title  ICMJE 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.
Brief Summary To investigate the potential antiepileptic effects of GWP42006 as add-on therapy in subjects with inadequately controlled focal seizures.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Epilepsy
  • Focal Seizures
Intervention  ICMJE
  • Drug: GWP42006
    Other Names:
    • Cannabidivarin
    • CBDV
  • Drug: Placebo Control
    Other Name: Placebo
Study Arms  ICMJE
  • Experimental: GWP42006
    GWP42006
    Intervention: Drug: GWP42006
  • Placebo Comparator: Placebo control
    Placebo
    Intervention: Drug: Placebo Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2017)
162
Original Estimated Enrollment  ICMJE
 (submitted: February 13, 2015)
100
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Hungary,   Italy,   Poland,   Spain,   United Kingdom
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02365610
Other Study ID Numbers  ICMJE GWEP1330 Part B
2014-002594-11 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GW Research Ltd
Study Sponsor  ICMJE GW Research Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Josemir W Sander, MD PhD FRCP NIRH University College London
PRS Account GW Research Ltd
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP