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NCT03355209 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome
A Phase 3 study, sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix.
- Completed
- Registry status
- Phase 3
- Development phase
- 296
- Enrollment target
NCT03355209 is a Phase 3 study that has completed, run by Zogenix International Limited, Inc., a subsidiary of Zogenix. The registered enrollment target is 296 participants.
The verdict
NCT03355209, a Phase 3 study, has completed, sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 296 participants
- Enrollment target
Study Summary
This is a two-part, multicenter, double-blind, parallel-group, placebo controlled study to evaluate the effect of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with Lennox-Gastaut syndrome (LGS).
Interventions
- DRUG Matching Placebo
- DRUG ZX008 0.2 or 0.8 mg/kg/day
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 296 participants |
| Start Date | 2017-11-27 |
| Est. Completion | 2024-05-23 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03355209
The ClinicalTrials.gov registry entry for NCT03355209 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 296 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zogenix International Limited, Inc., a subsidiary of Zogenix, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.
NCT03355209 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03355209 about?
NCT03355209 is a clinical study titled "A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome". This is a two-part, multicenter, double-blind, parallel-group, placebo controlled study to evaluate the effect of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with Lennox-Gastaut syndrome (LGS).
What is the current status of trial NCT03355209?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 296 participants. The study started on 2017-11-27. Estimated completion is 2024-05-23.
What interventions are being tested in trial NCT03355209?
The interventions under investigation include: Matching Placebo (DRUG), ZX008 0.2 or 0.8 mg/kg/day (DRUG).
Who is sponsoring clinical trial NCT03355209?
This trial is sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix, which has 6 total clinical trials registered on ClinicalTrials.gov.
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