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

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Brief Title

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

Official Title

An Exploratory, Pilot Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome: A Sub-study to the ZX008-1503 Open-Label Extension Trial

Brief Summary

      This is a sub-study to ZX008-1503. 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.
    

Detailed 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,
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Usability of the Empatica Embrace Seizure Detection watch system (Embrace) in outpatients with Dravet syndrome

Secondary Outcome

 Compare objective convulsive seizure count, as captured by the Embrace, to convulsive seizure count captured manually in the Embrace electronic seizure diary

Condition

Dravet Syndrome

Intervention

ZX008 (Fenfluramine Hydrochloride)

Study Arms / Comparison Groups

 ZX008
Description:  ZX008 is supplied as an oral solution in a concentration of 2.5 mg/mL. Subjects will be titrated to an effective dose beginning with 0.2 mg/kg/day (maximum: 30 mg/day).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20

Start Date

August 23, 2017

Completion Date

January 1, 2020

Primary Completion Date

January 1, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Subject is willing to wear the Embrace watch on the wrist (alternatively ankle, if
             needed for younger children). Subjects are asked to wear the watch for as many hours
             of the day as possible and for the entire night, if possible, for the duration of the
             sub-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 within
             close proximity of the paired iPod Touch running the Empatica Alert app.

        Exclusion Criteria:

          -  Subject has a known hypersensitivity to any of the Embrace device materials.

          -  Subject has a clinically significant condition, or has had clinically relevant
             symptoms or a clinically significant illness in the 4 weeks prior to Visit 1, other
             than epilepsy, that would negatively impact study participation, collection of study
             data, or pose a risk to the subject.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03299842

Organization ID

ZX008-1503-SS01


Responsible Party

Sponsor

Study Sponsor

Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.


Study Sponsor

, , 


Verification Date

June 2019