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: Unknown
• First Posted: October 3, 2017
• Last Update Posted: June 12, 2019
• Sponsor: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
• Information provided by (Responsible Party): Zogenix, Inc. ( Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. )

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.

Condition or disease	Intervention/treatment	Phase
Dravet Syndrome	Drug: ZX008 (Fenfluramine Hydrochloride)	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: ZX008-1503 Fenfluramine, open-label
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: August 23, 2017
• Estimated Primary Completion Date: January 1, 2020
• Estimated Study Completion Date: January 1, 2020

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

University of California San Francisco

San Francisco, California, United States, 94143

Sponsors and Collaborators

Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

More Information

• Responsible Party: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
• ClinicalTrials.gov Identifier: NCT03299842
• Other Study ID Numbers: ZX008-1503-SS01
• First Posted: October 3, 2017
• Last Update Posted: June 12, 2019
• Last Verified: June 2019

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

Keywords provided by Zogenix, Inc. ( Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. ):

seizure; tonic clonic; epilepsy; myoclonic; encephalopathy

Additional relevant MeSH terms:

Seizures; Epilepsies, Myoclonic; Syndrome; Disease; Pathologic Processes; Neurologic Manifestations; Nervous System Diseases; Epilepsy, Generalized; Epilepsy; Brain Diseases; Central Nervous System Diseases; Epileptic Syndromes; Fenfluramine; Selective Serotonin Reuptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs