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NCT03299842 · ClinicalTrials.gov registry record · Phase 3

A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome

A Phase 3 study, sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix.

Terminated
Registry status
Phase 3
Development phase
5
Enrollment target

NCT03299842: Clinical Trial Phase 3 study, sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix.

NCT03299842 is a Phase 3 study that was terminated before completion, run by Zogenix International Limited, Inc., a subsidiary of Zogenix. The registered enrollment target is 5 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03299842, a Phase 3 study, was terminated before completion, sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix.

TERMINATED
Registry status
Phase 3
Development phase
5 participants
Enrollment target

Study Summary

This is an exploratory sub-study to ZX008-1503 \[NCT02823145\]. Subjects will be fitted with an Embrace seizure detection watch and seizures detected by the watch will be compared to those entered into an electronic seizure diary.

Primary Outcome

The assessment of user experience with Embrace watch system included Likert Ease of Use Questionnaire. The questionnaire had 3 items related to use of the Embrace watch, Mate App and Alert App. All the questions were responded on 5-point Likert scale (1-Very difficult, 2-difficult, 3-Neutral, 4-Easy and 5-Very easy). Response to each item on the questionnaire was reported. Responses across all items on the questionnaire were summed to create an overall index with total score of 0 to 15, where hi

Interventions

  • DRUG ZX008 (Fenfluramine Hydrochloride)

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2017-07-12
Est. Completion 2018-07-05
Phase Phase 3

Why NCT03299842 stopped before completion

NCT03299842 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which ZX008 (Fenfluramine Hydrochloride) is the first listed.

NCT03299842 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03299842 about?

NCT03299842 is a clinical study titled "A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome". This is an exploratory sub-study to ZX008-1503 \[NCT02823145\]. Subjects will be fitted with an Embrace seizure detection watch and seizures detected by the watch will be compared to those entered into an electronic seizure diary.

What is the current status of trial NCT03299842?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 5 participants. The study started on 2017-07-12. Estimated completion is 2018-07-05.

What interventions are being tested in trial NCT03299842?

The interventions under investigation include: ZX008 (Fenfluramine Hydrochloride) (DRUG).

Who is sponsoring clinical trial NCT03299842?

This trial is sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix, which has 6 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03299842's enrollment target sits among peer trials

5 1997th of 2000 higher than 3 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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Source: ClinicalTrials.gov NCT03299842, the US trial registry maintained by the National Library of Medicine. NCT03299842 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.