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Completed

NCT Number: NCT02607904

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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

16 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

SEIN - Epilepsy Institute in the Netherlands Foundation, Zwolle, Netherlands

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GWP42003-P

Drug

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Jazz Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 18, 2015
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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