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NCT02926898 · ClinicalTrials.gov registry record · Phase 3
A 2-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children ≥ 2 Years Old 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
- 87
- Enrollment target
NCT02926898: Completed Phase 3 study, sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix.
NCT02926898 is a Phase 3 study that has completed, run by Zogenix International Limited, Inc., a subsidiary of Zogenix. The registered enrollment target is 87 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02926898, a Phase 3 study, has completed, sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 87 participants
- Enrollment target
Study Summary
The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of ZX008 (fenfluramine hydrochloride) when added to adjunctive antiepileptic stiripentol treatment in children and young adults with Dravet syndrome.
Primary Outcome
Monthly (28 day) convulsive seizure frequency (CSF) was based on electronic diary data obtained for each participant. Convulsive seizures included hemiclonic, focal with clear observable motor signs, generalized tonic clonic, secondarily generalized tonic clonic, tonic, clonic, and drop seizures (tonic/atonic). The number of convulsive seizures reported during the entire time interval was divided by the number of nonmissing diary days and the result was then multiplied by 28 to get a 28-day CSF.
Interventions
- DRUG Matching Placebo
- DRUG ZX008 (Fenfluramine Hydrochloride)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2017-01-27 |
| Est. Completion | 2018-06-05 |
| Phase | Phase 3 |
What the finished NCT02926898 record still lists
NCT02926898 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Matching Placebo is the first listed.
NCT02926898 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02926898 about?
NCT02926898 is a clinical study titled "A 2-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children ≥ 2 Years Old and Young Adults With Dravet Syndrome". The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of ZX008 (fenfluramine hydrochloride) when added to adjunctive antiepileptic stiripentol treatment in children and young adults with Dravet syndrome.
What is the current status of trial NCT02926898?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 87 participants. The study started on 2017-01-27. Estimated completion is 2018-06-05.
What interventions are being tested in trial NCT02926898?
The interventions under investigation include: Matching Placebo (DRUG), ZX008 (Fenfluramine Hydrochloride) (DRUG).
Who is sponsoring clinical trial NCT02926898?
This trial is sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02926898's enrollment target sits among peer trials
87 1742nd of 2000 higher than 256 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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