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
Stopped early · Phase 3
Conditions studied: Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome, Seizure in Participants With Lennox-Gastaut Syndrome
In brief
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).
Key facts
- Study ID
- NCT04485104
- Run by
- Jazz Pharmaceuticals
- People needed
- 3
- Starts
- 2021-05-19
- Expected to finish
- 2025-01-28
- Last updated by the study team
- 2025-10-31
Who can join
Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Clinical Trial Site — Little Rock, Arkansas, United States
- Clinical Trial Site — Los Angeles, California, United States
- Clinical Trial Site — Chicago, Illinois, United States
- Clinical Trial Site — Boston, Massachusetts, United States
- Clinical Trial Site — Cincinnati, Ohio, United States
- Clinical Trial Site — Houston, Texas, United States
- Clinical Trial Site — Florence, Italy
- Clinical Trial Site — Genova, Italy
- Clinical Trial Site — Rome, Italy
- Clinical Trial Site — Barcelona, Spain
- Clinical Trial Site — Madrid, Spain
Full record on ClinicalTrials.gov
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