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Serotonin Releaser

ZX008 0.2 to 0.8 mg/kg/day for Lennox Gastaut Syndrome

Phase 1
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 baseline to day 365
Awards & highlights
No Placebo-Only Group

Summary

This is an open label study to evaluate the safety of ZX008 (fenfluramine) in patients with Dravet syndrome (DS) or Lennox Gastaut syndrome (LGS) who are being administered cannabidiol (CBD).

Eligible Conditions
  • Lennox Gastaut Syndrome
  • Dravet Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 365
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 365 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events
Change in Heart Rate
Change in blood pressure
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ZX008 0.2 to 0.8 mg/kg/dayExperimental Treatment2 Interventions
ZX008 is supplied as an oral solution in a concentration of 2.5 mg/mL. Subjects will receive open-label ZX008 (flexible dosing 0.2 mg/kg/day to 0.8 mg/kg/day)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
2021
Completed Phase 3
~1010
ZX008 0.2 to 0.8 mg/kg/day
2018
Completed Phase 1
~10

Find a Location

Who is running the clinical trial?

Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.Lead Sponsor
11 Previous Clinical Trials
1,736 Total Patients Enrolled
2 Trials studying Lennox Gastaut Syndrome
708 Patients Enrolled for Lennox Gastaut Syndrome
~1 spots leftby Oct 2025
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