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Clinical trial

An Open-label, Single-arm Study to Assess the Safety, Pharmacokinetics, and Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Participants With Tuberous Sclerosis Complex (Age 1 Month to < 2 Years of Age), Dravet Syndrome (1 Year to < 2 Years of Age), or Lennox-Gastaut Syndrome (1 Year to < 2 Years of Age) Who Experience Inadequately-controlled Seizures

NCT04485104 is registered in ClinicalTrials.gov with Jazz Pharmaceuticals as lead sponsor.

NCT NCT04485104
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Registry record

As filed in ClinicalTrials.gov.

Title
An Open-label, Single-arm Study to Assess the Safety, Pharmacokinetics, and Efficacy of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Participants With Tuberous Sclerosis Complex (Age 1 Month to < 2 Years of Age), Dravet Syndrome (1 Year to < 2 Years of Age), or Lennox-Gastaut Syndrome (1 Year to < 2 Years of Age) Who Experience Inadequately-controlled Seizures
Lead sponsor
Jazz Pharmaceuticals
Phase
Phase 3
Overall status
Terminated
Start date
May 19, 2021
Completion date
January 28, 2025
Enrollment
3 (actual)
Sites
11

Conditions

As the registry lists them; a condition with its own page is linked.

seizure in participants with dravet syndrome, seizure in participants with lennox-gastaut syndrome, seizure in participants with tuberous sclerosis complex