Back to resultsA Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome
Primary Purpose
Dravet Syndrome
Status
Enrolling by invitation
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ZX008 (Fenfluramine Hydrochloride)
Sponsored by
About this trial
This is an interventional treatment trial for Dravet Syndrome focused on measuring seizure, tonic clonic, epilepsy, myoclonic, encephalopathy
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.
Sites / Locations
- University of California San Francisco
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ZX008
Arm 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).
Outcomes
Primary Outcome Measures
Usability of the Empatica Embrace Seizure Detection watch system (Embrace) in outpatients with Dravet syndrome
Caregiver burden as measured by the Perceived Stress Scale Questionnaire
Overall Usability of the Empatica Embrace Seizure Detection watch system (Embrace) in outpatients with Dravet syndrome
User experience as measured by the 5-point Likert Ease of Use Questionnaire
Secondary Outcome Measures
Compare objective convulsive seizure count, as captured by the Embrace, to convulsive seizure count captured manually in the Embrace electronic seizure diary
Full Information
NCT ID
NCT03299842
First Posted
September 10, 2017
Last Updated
June 11, 2019
Sponsor
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03299842
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 23, 2017 (Actual)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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,
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dravet Syndrome
Keywords
seizure, tonic clonic, epilepsy, myoclonic, encephalopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
ZX008-1503 Fenfluramine, open-label
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ZX008
Arm Type
Experimental
Arm 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).
Intervention Type
Drug
Intervention Name(s)
ZX008 (Fenfluramine Hydrochloride)
Intervention 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).
Primary Outcome Measure Information:
Title
Usability of the Empatica Embrace Seizure Detection watch system (Embrace) in outpatients with Dravet syndrome
Description
Caregiver burden as measured by the Perceived Stress Scale Questionnaire
Time Frame
12 weeks with the option to extend to 24 weeks
Title
Overall Usability of the Empatica Embrace Seizure Detection watch system (Embrace) in outpatients with Dravet syndrome
Description
User experience as measured by the 5-point Likert Ease of Use Questionnaire
Time Frame
12 weeks with the option to extend to 24 weeks
Secondary Outcome Measure Information:
Title
Compare objective convulsive seizure count, as captured by the Embrace, to convulsive seizure count captured manually in the Embrace electronic seizure diary
Time Frame
12 weeks with the option to extend to 24 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome
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