Trials / Completed
CompletedNCT03936777
A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome
An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy for Seizures in Patients With Rare Seizure Disorders Such as Epileptic Encephalopathies Including Dravet Syndrome and Lennox-Gastaut Syndrome
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 412 (actual)
- Sponsor
- Zogenix, Inc. · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
Summary
This is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy
Detailed description
This is an international, multicenter, open-label, long-term safety study of ZX008 in patients with epileptic encephalopathy, including Dravet syndrome or Lennox-Gastaut syndrome. Subjects eligible for participation are those with Dravet syndrome who are currently enrolled in Study ZX008-1503, or those with Lennox-Gastaut syndrome who have successfully completed Study ZX008-1601-Part 2, and are candidates for continued treatment with ZX008 for an extended period of time, or those with Dravet syndrome, Lennox-Gastaut syndrome, or another epileptic encephalopathy who have completed participation in another Zogenix-sponsored study and have been invited to participate in this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ZX008 (Fenfluramine Hydrochloride) | Fenfluramine hydrochloride provided in a concentration of 2.5 mg/mL. |
Timeline
- Start date
- 2019-04-22
- Primary completion
- 2025-05-08
- Completion
- 2025-05-08
- First posted
- 2019-05-03
- Last updated
- 2025-11-17
- Results posted
- 2025-11-17
Locations
71 sites across 14 countries: United States, Australia, Belgium, Canada, Denmark, France, Germany, Italy, Mexico, Netherlands, Poland, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03936777. Inclusion in this directory is not an endorsement.