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

Last updated: November 10, 2023
Sponsor: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Overall Status: Terminated

Phase

3

Condition

Rett Syndrome

Autism

Seizure Disorders (Pediatric)

Treatment

ZX008 (Fenfluramine Hydrochloride)

Clinical Study ID

NCT03299842
ZX008-1503-SS01
  • Ages 2-35
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meeting all of the main study ZX008-1503 [NCT02823145] inclusion criteria
  • Subject is willing to wear the Embrace watch on the wrist (alternatively ankle, ifneeded for younger children). Subjects are asked to wear the watch for as many hoursof the day as possible and for the entire night, if possible, for the duration of thesub-study.
  • Subject's parent/caregiver is willing to use the Alert App.
  • Subject/subject's caregiver is willing to ensure that the Embrace watch remains withinclose proximity of the paired iPod Touch running the Empatica Alert app.

Exclusion

Exclusion Criteria:

  • Subject has a known hypersensitivity to any of the Embrace device materials.
  • Subject has a clinically significant condition, or has had clinically relevantsymptoms or a clinically significant illness in the 4 weeks prior to Visit 1, otherthan epilepsy, that would negatively impact study participation, collection of studydata, or pose a risk to the subject.

Study Design

Total Participants: 5
Treatment Group(s): 1
Primary Treatment: ZX008 (Fenfluramine Hydrochloride)
Phase: 3
Study Start date:
July 12, 2017
Estimated Completion Date:
July 05, 2018

Study Description

This sub study will include up to 20 participants who meet the entry criteria for the main Study ZX008-1503 and who are willing to wear the Embrace watch and use the Embrace Alert app for 12 consecutive weeks. Those invited to participate will undergo all procedures included in the main study during their participation in this sub-study,

Connect with a study center

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • The Children's Hospital Colorado

    Aurora, Colorado 80045
    United States

    Site Not Available

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