Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-002939-18 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GWP42003-P | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who experienced an adverse event. | The number of participants who experienced an adverse event during the trial is presented. | Up to 48 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with a clinically significant change in 12-lead electrocardiogram (ECG). | The number of participants with a clinically significant change in ECG is presented. | Up to 48 weeks. |
| Number of participants with a clinically significant change in serum biochemistry. |
Not provided
Note: Participants who enroll in France or Sweden must be aged 18-55 years.
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SEIN - Epilepsy Institute in the Netherlands Foundation | Zwolle | Netherlands | ||||
| Hospital Universitari Vall d'Hebron |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
The number of participants with a clinically significant change in serum biochemistry is presented. |
| Up to 48 weeks. |
| Number of participants with a clinically significant change in hematology. | The number of participants with a clinically significant change in hematology is presented. | Up to 48 weeks. |
| Number of participants with a clinically significant change in urinalysis. | The number of participants with a clinically significant change in urinalysis is presented. | Up to 48 weeks. |
| Number of participants with a clinically significant change in vital signs. | The number of participants with a clinically significant change in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate) is presented. | Up to 48 weeks. |
| Number of participants with a clinically significant change in physical examination. | The number of participants with a clinically significant change in physical examination is presented. | Up to 48 weeks. |
| Number of participants with a treatment-emergent suicidality flag. | Suicidality was assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS). The number of participants with a treatment-emergent flag is presented. | Up to 48 weeks. |
| Seizure frequency by subtype. | The frequency of each subtype of seizure at baseline and end of treatment is presented. | Up to 48 weeks. |
| Number of participants with a treatment-emergent finding indicative of drug abuse liability. | 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. | Up to 48 weeks. |
| Barcelona |
| Spain |
| Hospital Ruber Internacional | Madrid | Spain |
| Hospital Universitario Virgen del Rocio | Seville | Spain |
| Sahlgrenska University Hospital | Gothenburg | Sweden |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
Not provided
Not provided