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

NCT03299842 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: ZX008-1503-SS01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Dravet Syndrome

Keywords

seizure; tonic clonic; epilepsy; myoclonic; encephalopathy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

ZX008

EXPERIMENTAL

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)

Interventions

ZX008 (Fenfluramine Hydrochloride) DRUG

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).

ZX008

Eligibility Criteria

• Age: 2 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.: lead

Study Sites (2)

University of California San Francisco

San Francisco, California, 94143, United States

Location

The Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Epilepsies, Myoclonic; Seizures; Epilepsy; Brain Diseases

Interventions

Fenfluramine

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals

Limitations and Caveats

No data will be reported, as the exploratory sub-study was investigating a rare disease in pediatrics with a high risk of participant identification due to low enrolment (participant privacy/confidentiality issue). Safety Data for eligible participants in the sub-study was collected in the main study ZX008-1503 (NCT02823145) as pre-specified in the protocol. The data will be disclosed with the main study results posting.

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  001 844 599 2273

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: ZX008-1503 Fenfluramine, open-label

Study Record Dates

• First Submitted: September 10, 2017
• First Posted: October 3, 2017
• Study Start: July 12, 2017
• Primary Completion: July 5, 2018
• Study Completion: July 5, 2018
• Last Updated: November 13, 2023
• Results First Posted: November 13, 2023

Record last verified: 2023-11

Locations

US (2)