drugset / Trial / NCT04485104
Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures
Phase 3
Terminated
3 enrolled
Jazz Pharmaceuticals
Jazz Pharmaceuticals Research UK Limited · collab
NaSingle-groupOpen-labelTreatment
Summary
This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of adjunctive GWP42003-P in participants \< 2 years of age with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS), or Dravet syndrome (DS).
Timeline
- Start
- 2021-05-19
- Primary completion
- 2025-01-28
- Completion
- 2025-01-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cannabidiol | Other / unclassified | 10 mg/kg | Oral |
| Subject | Cannabidiol | Other / unclassified | 12.5 mg/kg | Oral |