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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 : Enrolling by invitation
First Posted : November 18, 2015
Last Update Posted : November 1, 2017
Sponsor:
Information provided by (Responsible Party):
GW Research Ltd

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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: GWP42003-P Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 12-month treatment period. 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.

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.



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Ages Eligible for Study:   16 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: GW Research Ltd
ClinicalTrials.gov Identifier: NCT02607904     History of Changes
Other Study ID Numbers: GWEP1447 Open-label Extension
2015-002939-18 ( EudraCT Number )
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by GW Research Ltd:
Cannabidiol
GWP42003-P
Epidiolex
Stiripentol
Valproate
Additional relevant MeSH terms:
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Epidiolex
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Valproic Acid
Stiripentol
Anticonvulsants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs