Epilepsy Clinical Trial
Official title:
A Double Blind, Placebo-controlled, Two-part Study to Investigate the Dose-ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome
Verified date | September 2022 |
Source | Jazz Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the safety and pharmacokinetics (PK) of multiple doses of GWP42003-P compared with placebo in children with Dravet syndrome.
Status | Completed |
Enrollment | 34 |
Est. completion date | March 9, 2015 |
Est. primary completion date | March 9, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 10 Years |
Eligibility | Key Inclusion Criteria: - Participants were male or female aged between 4 and 10 years (inclusive). - Participants had a documented history of Dravet Syndrome that was not completely controlled by AEDs. - Participants took one or more AEDs at a dose which had been stable for at least 4 weeks. - Participants had experienced fewer than 4 convulsive seizures (tonic-clonic, tonic, clonic, atonic seizures) during the 28-day baseline period. - All medications or interventions for epilepsy (including ketogenic diet and vagus nerve stimulation [VNS]) were stable for four weeks prior to screening and participants were willing to maintain a stable regimen throughout the study. The ketogenic diet and VNS treatments were not counted as an AED. Key Exclusion Criteria: - Participants had clinically significant unstable medical conditions other than epilepsy. - Participants had clinically relevant abnormalities in the 12-lead electrocardiogram measured at screening or randomization. - Participants were currently using or had in the past used recreational or medicinal cannabis, or synthetic CBD based medications (including Sativex®) within the 3 months prior to study entry and were unwilling to abstain for the duration for the study. - Participants had any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP. - Participants who had been part of a clinical trial involving another investigational product in the previous 6 months. - There were plans for the participants to travel outside their country of residence during the study. - Participants were previously randomized into this study. In particular, participants participating in Part A of the study cannot enter Part B. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Jazz Pharmaceuticals |
United States, United Kingdom,
Devinsky O, Patel AD, Thiele EA, Wong MH, Appleton R, Harden CL, Greenwood S, Morrison G, Sommerville K; GWPCARE1 Part A Study Group. Randomized, dose-ranging safety trial of cannabidiol in Dravet syndrome. Neurology. 2018 Apr 3;90(14):e1204-e1211. doi: 10.1212/WNL.0000000000005254. Epub 2018 Mar 14. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number Of Participants Who Experienced Severe Treatment-Emergent Adverse Events (TEAEs) | A TEAE was defined as an adverse event (AE) with an onset date on or after the first dose of IMP. If an AE had a partial onset date and it was unclear from the partial date (or the stop date) whether the AE started prior to or following the first dose of IMP then the AE was considered a TEAE. The number of participants who experienced one or more severe TEAEs after dosing on Day 1 through the Safety Follow-up Visit (Day 60) is presented.
A summary of serious and all other non-serious AEs regardless of causality is located in the Adverse Events module. |
Baseline (Day 1) through Safety follow-up visit (Day 60) | |
Secondary | Area Under The Concentration-Time Curve Calculated To The Last Observable Concentration At Time T (AUC0-t) For CBD And Its Metabolites At Days 1 And 22 | AUC0-t for CBD and its major metabolites, 6-hydroxy-CBD (6-OH-CBD), 7-hydroxy-CBD (7-OH-CBD), and 7-carboxy-CBD (7-COOH-CBD) were calculated using blood samples collected before and after IMP dosing on Days 1 and 22. One sample was collected predose, 2 to 3 hours postdose, and 4 to 6 hours postdose for CBD and its metabolites. Results are presented for participants who received GWP42003-P at 5, 10, or 20 mg/kg/day during the study and for participants with a numeric result for the given evaluation. | Predose and 2-6 hours postdose on Days 1 and 22 | |
Secondary | Mean Percentage Change From Baseline To End Of Treatment In Plasma Clobazam (CLB) And N-Desmethylclobazam (N-CLB) Concentrations | Plasma concentrations of CLB and N-CLB were measured on Days 1 and 22. Participants were instructed to take their daily dose of CLB 2 hours prior to the anticipated pre-IMP blood specimen collection on both days. Blood samples were collected prior to administration of IMP. Results are presented for a subgroup of participants who took CLB during the study and had PK samples analyzed at both PK sampling visits (Days 1 and 22). | Predose on Days 1 and 22 |
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