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

• ClinicalTrials.gov Identifier: NCT03299842
• Recruitment Status: Terminated
• First Posted: October 3, 2017
• Results First Posted: November 13, 2023
• Last Update Posted: November 13, 2023
• Sponsor: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
• Information provided by (Responsible Party): UCB Pharma ( Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. )

Tracking Information

• First Submitted Date: September 10, 2017
• First Posted Date: October 3, 2017
• Results First Submitted Date: September 18, 2023
• Results First Posted Date: November 13, 2023
• Last Update Posted Date: November 13, 2023
• Actual Study Start Date: July 12, 2017
• Actual Primary Completion Date: July 5, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 18, 2023)

Overall Usability of the Empatica Embrace Seizure Detection Watch System (Embrace) in Outpatients With Dravet Syndrome [ Time Frame: Approximately 12 weeks ]

The assessment of user experience with Embrace watch system included Likert Ease of Use Questionnaire. The questionnaire had 3 items related to use of the Embrace watch, Mate App and Alert App. All the questions were responded on 5-point Likert scale (1-Very difficult, 2-difficult, 3-Neutral, 4-Easy and 5-Very easy). Response to each item on the questionnaire was reported. Responses across all items on the questionnaire were summed to create an overall index with total score of 0 to 15, where higher scores represents the better usability of the device.

Original Primary Outcome Measures (submitted: October 1, 2017)

• Usability of the Empatica Embrace Seizure Detection watch system (Embrace) in outpatients with Dravet syndrome [ Time Frame: 12 weeks with the option to extend to 24 weeks ]
  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 [ Time Frame: 12 weeks with the option to extend to 24 weeks ]
  User experience as measured by the 5-point Likert Ease of Use Questionnaire

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (submitted: October 1, 2017): 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 ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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 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.
• 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 Type: Interventional
• Study Phase: Phase 3

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

ZX008-1503 Fenfluramine, open-label

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Dravet Syndrome

Intervention

Drug: ZX008 (Fenfluramine Hydrochloride)

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).

Study Arms

Experimental: ZX008

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: Drug: ZX008 (Fenfluramine Hydrochloride)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: September 18, 2023): 5
• Original Estimated Enrollment (submitted: October 1, 2017): 20
• Actual Study Completion Date: July 5, 2018
• Actual Primary Completion Date: July 5, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Years to 35 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03299842
• Other Study ID Numbers: ZX008-1503-SS01
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: UCB Pharma ( Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. )
• Original Responsible Party: Same as current
• Current Study Sponsor: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: UCB Cares; 001 844 599 2273

• PRS Account: UCB Pharma
• Verification Date: November 2023