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

NCT03299842 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-11-13

Study results available
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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

Interventions

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).

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-12
Primary Completion
2018-07-05
Completion
2018-07-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03299842 on ClinicalTrials.gov