Epilepsy
Conditions
Keywords
Cannabidiol, GWP42003-P, Epidiolex, Stiripentol, Valproate
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.
Interventions
DRUGGWP42003-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.
Sponsors
Jazz Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 55 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who experienced an adverse event. | Up to 48 weeks. | The number of participants who experienced an adverse event during the trial is presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with a clinically significant change in serum biochemistry. | 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. | 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. | 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. | 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 12-lead electrocardiogram (ECG). | Up to 48 weeks. | The number of participants with a clinically significant change in ECG is presented. |
| Number of participants with a treatment-emergent suicidality flag. | 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. | 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. | 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. |
| Number of participants with a clinically significant change in physical examination. | Up to 48 weeks. | The number of participants with a clinically significant change in physical examination is presented. |
Countries
Netherlands, Spain, Sweden
Outcome results
None listed