drugset / Trial / NCT05288283
Efficacy and Safety of GWP42003-P Oral Solution in Children With Epilepsy With Myoclonic-atonic Seizures
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary aim of Part A of the study to assess the efficacy and tolerability of GWP42003-P compared to placebo as an adjunctive treatment for children with Epilepsy with myoclonic-atonic seizures (EMAS) -associated seizures. Part B of this study will be conducted to evaluate the long-term safety and tolerability of GWP42003-P in participants with EMAS.
Timeline
- Start
- 2022-10-31
- Primary completion
- 2023-09-28
- Completion
- 2023-09-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cannabidiol | Other / unclassified | 5 mg/kg | Oral |
| Subject | Cannabidiol | Other / unclassified | 7.5 mg/kg | Oral |
| Subject | Cannabidiol | Other / unclassified | 10 mg/kg | Oral |