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NCT02682927 · ClinicalTrials.gov registry record · Phase 3
A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome
A Phase 3 study, sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix.
- Completed
- Registry status
- Phase 3
- Development phase
- 262
- Enrollment target
NCT02682927 is a Phase 3 study that has completed, run by Zogenix International Limited, Inc., a subsidiary of Zogenix. The registered enrollment target is 262 participants.
The verdict
NCT02682927, a Phase 3 study, has completed, sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 262 participants
- Enrollment target
Study Summary
Study 1 and Study 3 are the prospective, merged analyses of 2 identical double-blind, placebo-controlled studies, ZX008-1501 and ZX008-1502, to assess the efficacy, safety, and pharmacokinetics of ZX008 when used as adjunctive therapy in pediatric and young adult subjects with Dravet syndrome. Study 1501 and Study 1502 were conducted in parallel; Study 1501 was conducted at approximately 30 study sites in North America; Study 1502 was conducted at approximately 30 study sites in Europe, Asia and Australia. Upon completion of the Baseline Period after initial Screening and Baseline charting of seizure frequency, subjects who qualified for the studies were randomized (1:1:1) in a double-blind manner to receive either 1 of 2 doses of ZX008 (0.2 mg/kg/day or 0.8 mg/kg/day; maximum dose: 30 mg/day) or placebo. Randomization was stratified by age group (\< 6 years, ≥6 to 18 years) to achieve balance across treatment arms, with the target of 25% of subjects in each age group. All subjects were titrated to their randomized dose over a 14-day Titration Period. Following titration, subjects continued treatment at their randomly assigned dose over a 12-week Maintenance Period. Subjects exiting the study underwent a 2-week taper, unless they enrolled in a follow-on study. Subjects were followed for post-study safety monitoring.
Interventions
- DRUG Matching Placebo
- DRUG ZX008 (Fenfluramine Hydrochloride)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 262 participants |
| Start Date | 2016-01-15 |
| Est. Completion | 2020-07-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02682927
The ClinicalTrials.gov registry entry for NCT02682927 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 262 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.
NCT02682927 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02682927 about?
NCT02682927 is a clinical study titled "A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome". Study 1 and Study 3 are the prospective, merged analyses of 2 identical double-blind, placebo-controlled studies, ZX008-1501 and ZX008-1502, to assess the efficacy, safety, and pharmacokinetics of ZX008 when used as adjunctive therapy in pediatric and young adult subjects with Dravet syndrome. Study...
What is the current status of trial NCT02682927?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 262 participants. The study started on 2016-01-15. Estimated completion is 2020-07-29.
What interventions are being tested in trial NCT02682927?
The interventions under investigation include: Matching Placebo (DRUG), ZX008 (Fenfluramine Hydrochloride) (DRUG).
Who is sponsoring clinical trial NCT02682927?
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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