NCT03299842

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. · Industry
• Sex: All
• Age: 2 Years – 35 Years
• Healthy volunteers: Not accepted

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,

Conditions

• Dravet Syndrome

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2017-07-12
• Primary completion: 2018-07-05
• Completion: 2018-07-05
• First posted: 2017-10-03
• Last updated: 2023-11-13
• Results posted: 2023-11-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study