Status:
TERMINATED
A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome
Lead Sponsor:
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Conditions:
Dravet Syndrome
Eligibility:
All Genders
2-35 years
Phase:
PHASE3
Brief 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 int...
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 consecuti...
Eligibility Criteria
Inclusion
- Meeting all of the main study ZX008-1503 \[NCT02823145\] 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
- 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.
Key Trial Info
Start Date :
July 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2018
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03299842
Start Date
July 12 2017
End Date
July 5 2018
Last Update
November 13 2023
Active Locations (2)
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1
University of California San Francisco
San Francisco, California, United States, 94143
2
The Children's Hospital Colorado
Aurora, Colorado, United States, 80045