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ZX008 for Dravet Syndrome

Phase 3
Waitlist Available
Research Sponsored by Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks with the option to extend to 24 weeks
Awards & highlights

Study 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.

Eligible Conditions
  • Dravet Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks with the option to extend to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks with the option to extend to 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Usability of the Empatica Embrace Seizure Detection Watch System (Embrace) in Outpatients With Dravet Syndrome
Secondary outcome measures
Compare objective convulsive seizure count, as captured by the Embrace, to convulsive seizure count captured manually in the Embrace electronic seizure diary

Side effects data

From 2020 Phase 3 trial • 262 Patients • NCT02682927
38%
Decreased appetite
21%
Somnolence
19%
Pyrexia
17%
Blood glucose decreased
17%
Echocardiogram abnormal
15%
Diarrhoea
13%
Tremor
10%
Fatigue
8%
Upper respiratory tract infection
8%
Platelet count decreased
8%
Weight decreased
8%
Rash
6%
Cough
6%
Vomiting
6%
Lethargy
6%
Asthenia
6%
Hypoglycaemia
4%
Drooling
4%
Viral infection
4%
Rhinitis
4%
Blood pressure increased
4%
Ataxia
4%
Balance disorder
4%
Abnormal behaviour
2%
Irritability
2%
Urinary tract infection
2%
Varicella
2%
Toxicity to various agents
2%
Hepatic enzyme increased
2%
Nasopharyngitis
2%
Blood pressure diastolic increased
2%
Constipation
2%
Gait disturbance
2%
Influenza
2%
Sinusitis
2%
Fall
2%
Hypotonia
2%
Seizure
2%
Urinary incontinence
2%
Rhinorrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Study 3: ZX008 0.8 mg/kg/Day
Study 1: Placebo
Study 1: ZX008 0.2 mg/kg/Day
Study 1: ZX008 0.8 mg/kg/Day
Study 3: Placebo
Study 3: ZX008 0.2 mg/kg/Day

Trial Design

1Treatment groups
Experimental Treatment
Group I: ZX008Experimental Treatment1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fenfluramine
FDA approved

Find a Location

Who is running the clinical trial?

Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.Lead Sponsor
11 Previous Clinical Trials
1,740 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273
205 Previous Clinical Trials
44,958 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome
2017. "A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03299842.
~1 spots leftby Apr 2025
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