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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 November 2023 |
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Main ID: |
NCT03299842 |
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Date of registration:
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10/09/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome
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Scientific title:
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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 |
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Date of first enrolment:
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July 12, 2017 |
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Target sample size:
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5 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT03299842 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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UCB Cares |
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Address:
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Telephone:
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Email:
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Affiliation:
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001 844 599 2273 |
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Key inclusion & exclusion criteria
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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, 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.
Age minimum:
2 Years
Age maximum:
35 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Dravet Syndrome
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Intervention(s)
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Drug: ZX008 (Fenfluramine Hydrochloride)
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Primary Outcome(s)
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Overall Usability of the Empatica Embrace Seizure Detection Watch System (Embrace) in Outpatients With Dravet Syndrome
[Time Frame: Approximately 12 weeks]
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Secondary ID(s)
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ZX008-1503-SS01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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