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An Open-label Extension Trial to Investigate Possible Drug-drug Interactions Between Stiripentol or Valproate and Cannabidiol in Patients With Epilepsy

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ClinicalTrials.gov Identifier: NCT02607904
Recruitment Status : Completed
First Posted : November 18, 2015
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
GW Research Ltd

Tracking Information
First Submitted Date  ICMJE November 16, 2015
First Posted Date  ICMJE November 18, 2015
Last Update Posted Date September 25, 2019
Actual Study Start Date  ICMJE December 15, 2016
Actual Primary Completion Date May 27, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
Number of participants who experienced an adverse event. [ Time Frame: Up to 48 weeks. ]
The number of participants who experienced an adverse event during the trial is presented.
Original Primary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
Number of participants who experienced an adverse event. [ Time Frame: Up to 1 year. ]
The number of participants who experienced an adverse event during the trial is presented.
Change History Complete list of historical versions of study NCT02607904 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2019)
  • Number of participants with a clinically significant change in 12-lead electrocardiogram (ECG). [ Time Frame: Up to 48 weeks. ]
    The number of participants with a clinically significant change in ECG is presented.
  • Number of participants with a clinically significant change in serum biochemistry. [ Time Frame: Up to 48 weeks. ]
    The number of participants with a clinically significant change in serum biochemistry is presented.
  • Number of participants with a clinically significant change in hematology. [ Time Frame: Up to 48 weeks. ]
    The number of participants with a clinically significant change in hematology is presented.
  • Number of participants with a clinically significant change in urinalysis. [ Time Frame: Up to 48 weeks. ]
    The number of participants with a clinically significant change in urinalysis is presented.
  • Number of participants with a clinically significant change in vital signs. [ Time Frame: Up to 48 weeks. ]
    The number of participants with a clinically significant change in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate) is presented.
  • Number of participants with a clinically significant change in physical examination. [ Time Frame: Up to 48 weeks. ]
    The number of participants with a clinically significant change in physical examination is presented.
  • Number of participants with a treatment-emergent suicidality flag. [ Time Frame: Up to 48 weeks. ]
    Suicidality was assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS). The number of participants with a treatment-emergent flag is presented.
  • Seizure frequency by subtype. [ Time Frame: Up to 48 weeks. ]
    The frequency of each subtype of seizure at baseline and end of treatment is presented.
  • Number of participants with a treatment-emergent finding indicative of drug abuse liability. [ Time Frame: Up to 48 weeks. ]
    Abuse liability was assessed through monitoring of triggering adverse events of interest and study medication accountability discrepancies. Any findings were assigned to an appropriate classification by the investigator. The number of participants with a treatment-emergent finding indicative of drug abuse liability is presented.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2015)
  • Number of participants with a clinically significant change in 12-lead electrocardiogram (ECG). [ Time Frame: Up to 1 year. ]
    The number of participants with a clinically significant change in ECG is presented.
  • Number of participants with a clinically significant change in serum biochemistry. [ Time Frame: Up to 1 year. ]
    The number of participants with a clinically significant change in serum biochemistry is presented.
  • Number of participants with a clinically significant change in hematology. [ Time Frame: Up to 1 year. ]
    The number of participants with a clinically significant change in hematology is presented.
  • Number of participants with a clinically significant change in urinalysis. [ Time Frame: Up to 1 year. ]
    The number of participants with a clinically significant change in urinalysis is presented.
  • Number of participants with a clinically significant change in vital signs. [ Time Frame: Up to 1 year. ]
    The number of participants with a clinically significant change in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate) is presented.
  • Number of participants with a clinically significant change in physical examination. [ Time Frame: Up to 1 year. ]
    The number of participants with a clinically significant change in physical examination is presented.
  • Number of participants with a treatment-emergent suicidality flag. [ Time Frame: Up to 1 year. ]
    Suicidality was assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS). The number of participants with a treatment-emergent flag is presented.
  • Seizure frequency by subtype. [ Time Frame: Up to 1 year. ]
    The frequency of each subtype of seizure at baseline and end of treatment is presented.
  • Number of participants with a treatment-emergent finding indicative of drug abuse liability. [ Time Frame: Up to 1 year. ]
    Abuse liability was assessed through monitoring of triggering adverse events of interest and study medication accountability discrepancies. Any findings were assigned to an appropriate classification by the investigator. The number of participants with a treatment-emergent finding indicative of drug abuse liability is presented.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-label Extension Trial to Investigate Possible Drug-drug Interactions Between Stiripentol or Valproate and Cannabidiol in Patients With Epilepsy
Official Title  ICMJE A Phase 2, Double-blind, Randomized, Placebo-controlled Pharmacokinetic Trial in 2 Parallel Groups to Investigate Possible Drug-drug Interactions Between Stiripentol or Valproate and GWP42003-P in Patients With Epilepsy
Brief Summary This trial consists of 2 parts: a double-blinded phase and an open-label extension phase. The open-label extension phase only will be described in this record. All participants will receive the same dose of GWP42003-P. However, investigators may subsequently decrease or increase the participant's dose until the optimal dose is found.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE Drug: GWP42003-P
Clear, colorless to yellow solution containing cannabidiol (CBD) dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
Other Names:
  • Cannabidiol
  • CBD
  • Epidiolex
Study Arms  ICMJE Experimental: GWP42003-P

Administered orally, twice daily (morning and evening), commencing with titration of 100 mg/mL GWP42003-P to 20 mg/kg/day over 10 days in a blinded manner (i.e., only participants taking placebo in the blinded phase will up-titrate; doses will remain unchanged for those taking GWP42003-P in the blinded phase).

Participants remain on the maintenance dose for the remainder of the 48-week treatment period, until early withdrawal or at an early study conclusion date defined by the sponsor. However, investigators may subsequently decrease or increase the participant's dose (to a maximum of 30 mg/kg/day) until the optimum dose is found.

Dosing is tapered (10% each day) for participants who do not immediately continue to use GWP42003-P once market authorization is granted, or for those who withdraw early.

Intervention: Drug: GWP42003-P
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 23, 2019)
30
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2015)
40
Actual Study Completion Date  ICMJE May 27, 2019
Actual Primary Completion Date May 27, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Note: Participants who enroll in France or Sweden must be aged 18-55 years.

Key Inclusion Criteria:

  • Participant must have a documented magnetic resonance imaging/computerized tomography of the brain that ruled out a progressive neurologic condition.

Key Exclusion Criteria:

  • Participant has clinically significant unstable medical conditions other than epilepsy.
  • Participant has a history of symptoms related to a drop in blood pressure due to postural changes (e.g., dizziness, light-headedness, blurred vision, palpitations, weakness, syncope).
  • Participant has any history of suicidal behavior or any suicidal ideation of type 4 or 5 on the C-SSRS in the last month.
  • Participant is currently using felbamate and has been taking it for less than 12 months prior to screening visit of the blinded phase of the trial.
  • Participant is currently using or has in the past used recreational or medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the 3 months prior to trial entry.
  • Participant has any known or suspected history of any drug abuse or addiction.
  • Participant is unwilling to abstain from recreational or medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex) for the duration for the trial.
  • Participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the Investigational Medicinal Product (IMP), e.g., sesame oil.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands,   Spain,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02607904
Other Study ID Numbers  ICMJE GWEP1447 Open-label Extension
2015-002939-18 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party GW Research Ltd
Study Sponsor  ICMJE GW Research Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account GW Research Ltd
Verification Date September 2019

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