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Serotonin Receptor Agonist

ZX008 (Fenfluramine Hydrochloride) 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
Male or non-pregnant, non-lactating female, age 2 to 18 years, inclusive as of the day of the core study Screening Visit.
Satisfactory completion of the core study in the opinion of the investigator and the sponsor.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at month 1, month 2, month 3, month 4-6, month 7-9, month 10-12, month 13-15, month 16-18, month 19-21, month 22-24, month 25-27, month 28-30, month 31-33, and month 34-36
Awards & highlights

Study Summary

This trial will observe the long-term safety of ZX008 in people with Dravet syndrome.

Eligible Conditions
  • Dravet Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at month 1, month 2, month 3, month 4-6, month 7-9, month 10-12, month 13-15, month 16-18, month 19-21, month 22-24, month 25-27, month 28-30, month 31-33, and month 34-36
This trial's timeline: 3 weeks for screening, Varies for treatment, and at month 1, month 2, month 3, month 4-6, month 7-9, month 10-12, month 13-15, month 16-18, month 19-21, month 22-24, month 25-27, month 28-30, month 31-33, and month 34-36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Serious Treatment-emergent Adverse Events (TEAEs) During the OLE Treatment Period
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) During the Open-label Extension (OLE) Treatment Period
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Withdrawal From Investigational Medicinal Product (IMP) During the OLE Treatment Period
Secondary outcome measures
Change From Baseline (Core) in Convulsive Seizure Frequency Per 28 Days From Day 1 to End of Study (EOS) Visit (Month 42) in the OLE Treatment Period
Change From Baseline (Core) in Convulsive Seizure Frequency Per 28 Days From Month 2 to EOS (Month 42) in the OLE Treatment Period
Convulsive Seizure Frequency (CSF) Per 28 Days During the OLE Treatment Period (to Month 36)
+2 more

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
ZX008 (Fenfluramine Hydrochloride)
2016
Completed Phase 3
~730

Find a Location

Who is running the clinical trial?

Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.Lead Sponsor
11 Previous Clinical Trials
1,370 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273
203 Previous Clinical Trials
43,987 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the sample size for this experiment?

"This clinical trial is not enrolling patients at the moment. It was originally posted on July 5th, 2016 and last updated November 8th, 2022. If you are looking for other trials, there are currently 1452 trials actively enrolling patients with epilepsies and 6 trials for ZX008 (Fenfluramine Hydrochloride) that need participants."

Answered by AI

Who does this trial hope to enroll as participants?

"Eligible patients for this trial must have a diagnosis of epilepsy, myoclonic subtype and be between 2-35 years old. Currently, the study is looking to recruit a total of 373 individuals."

Answered by AI

Does this study have an age limit?

"Based on the age parameters set out in this study's eligibility requirements, the lower bound for participants is 2 years old while the upper limit is 35."

Answered by AI

Are we still able to enroll new participants in this experiment?

"From what is detailed on clinicaltrials.gov, this particular trial is not looking for new patients as of now. This trial was initially posted on July 5th 2016 and has had its most recent update on November 8th 2022. Even though this study isn't searching for participants, there are 1,458 other trials that currently are."

Answered by AI

What kind of side effects does ZX008 (Fenfluramine Hydrochloride) have?

"ZX008 (Fenfluramine Hydrochloride) has received a score of 3 from our analysts at Power. This is because it is a Phase 3 trial, which means that there is both evidence supporting its efficacy and multiple rounds of data collected on its safety."

Answered by AI

How many different places are testing this out?

"Children's Hospital of Philadelphia (Philadelphia, Pennsylvania), Seattle Children's Hospital (Seattle, Washington), Neurology and Epilepsy Research Center (Orlando, Florida) are the 4 primary sites for this trial. Additionally, there are 26 other hospitals participating in this clinical study."

Answered by AI

Are there any other notable cases of ZX008 (Fenfluramine Hydrochloride) being tested in a medical setting?

"ZX008 (Fenfluramine Hydrochloride) was first evaluated in 2016 at The Children's Hospital Colorado. Out of the 5 completed clinical trials, 6 are presently active- many of which are based in Philadelphia, Pennsylvania."

Answered by AI

Does this research break new ground in the medical field?

"ZX008 (Fenfluramine Hydrochloride) has been researched since 2016 by Zogenix International Limited, Inc.. The first Phase 3 clinical trial occurred in 373 patients across 56 cities and 15 countries."

Answered by AI
~43 spots leftby Mar 2025