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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
Be younger than 65 years old
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

Summary

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

Eligible Conditions
  • Dravet Syndrome

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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
35%
Decreased appetite
23%
Echocardiogram abnormal
18%
Diarrhoea
18%
Lethargy
18%
Nasopharyngitis
10%
Constipation
10%
Fatigue
8%
Vomiting
8%
Hypotonia
8%
Abnormal behaviour
8%
Blood prolactin increased
8%
Blood pressure diastolic increased
8%
Somnolence
8%
Ataxia
5%
Seizure
5%
Drooling
5%
Blood pressure increased
5%
Rash
5%
Pyrexia
5%
Status epilepticus
3%
Sinusitis
3%
Irritability
3%
Weight decreased
3%
Tremor
3%
Cough
3%
Rhinitis
3%
Croup infectious
3%
Ear infection
3%
Salivary hypersecretion
3%
Heart rate increased
3%
Balance disorder
3%
Urinary incontinence
3%
Rhinorrhoea
3%
Platelet count decreased
3%
Hypoglycaemia
3%
Adverse drug reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Study 1: ZX008 0.8 mg/kg/Day
Study 3: ZX008 0.2 mg/kg/Day
Study 3: ZX008 0.8 mg/kg/Day
Study 3: Placebo
Study 1: ZX008 0.2 mg/kg/Day
Study 1: Placebo

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
213 Previous Clinical Trials
45,076 Total Patients Enrolled
~41 spots leftby Sep 2025
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