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

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

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.

Study Overview

• Status: Terminated
• Conditions: Dravet Syndrome
• Intervention / Treatment: Drug: ZX008 (Fenfluramine Hydrochloride)

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
• Enrollment (Actual): 5
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco
  • Colorado
    • Aurora, Colorado, United States, 80045
      • The Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Usability of the Empatica Embrace Seizure Detection Watch System (Embrace) in Outpatients With Dravet Syndrome	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.	Approximately 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Compare objective convulsive seizure count, as captured by the Embrace, to convulsive seizure count captured manually in the Embrace electronic seizure diary	12 weeks with the option to extend to 24 weeks

Collaborators and Investigators

• Sponsor: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
• Investigators: Study Director: UCB Cares, 001 844 599 2273

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2017
• Primary Completion (Actual): July 5, 2018
• Study Completion (Actual): July 5, 2018

Study Registration Dates

• First Submitted: September 10, 2017
• First Submitted That Met QC Criteria: October 1, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: epilepsy; seizure; myoclonic; encephalopathy; tonic clonic
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy, Generalized; Epileptic Syndromes; Neurologic Manifestations; Disease; Epilepsy; Epilepsies, Myoclonic; Syndrome; Seizures; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Selective Serotonin Reuptake Inhibitors; Fenfluramine
• Other Study ID Numbers: ZX008-1503-SS01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No