A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome
Completed · Phase 3 · Has a placebo group
Conditions studied: Dravet Syndrome, Seizure Disorder
In brief
Study 1 and Study 3 are the prospective, merged analyses of 2 identical double-blind, placebo-controlled studies, ZX008-1501 and ZX008-1502, to assess the efficacy, safety, and pharmacokinetics of ZX008 when used as adjunctive therapy in pediatric and young adult subjects with Dravet syndrome. Study 1501 and Study 1502 were conducted in parallel; Study 1501 was conducted at approximately 30 study sites in North America; Study 1502 was conducted at approximately 30 study sites in Europe, Asia and Australia. Upon completion of the Baseline Period after initial Screening and Baseline charting of seizure frequency, subjects who qualified for the studies were randomized (1:1:1) in a double-blind manner to receive either 1 of 2 doses of ZX008 (0.2 mg/kg/day or 0.8 mg/kg/day; maximum dose: 30 mg/day) or placebo. Randomization was stratified by age group (\< 6 years, ≥6 to 18 years) to achieve balance across treatment arms, with the target of 25% of subjects in each age group. All subjects were titrated to their randomized dose over a 14-day Titration Period. Following titration, subjects continued treatment at their randomly assigned dose over a 12-week Maintenance Period. Subjects exiting the study underwent a 2-week taper, unless they enrolled in a follow-on study. Subjects were followed for post-study safety monitoring.
Key facts
- Study ID
- NCT02682927
- Run by
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
- People needed
- 262
- Starts
- 2016-01-15
- Expected to finish
- 2020-07-29
- Last updated by the study team
- 2023-09-28
Who can join
Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Center for Neurosciences - Tucson — Tucson, Arizona, United States
- Rady Children's Hospital San Diego — San Diego, California, United States
- University of California San Francisco — San Francisco, California, United States
- The Children's Hospital Colorado — Aurora, Colorado, United States
- NW FL Clinical Research Group, LLC — Gulf Breeze, Florida, United States
- Miami Children's Hospital Brain Institute — Miami, Florida, United States
- Neurology and Epilepsy Research Center — Orlando, Florida, United States
- Panda Neurology — Atlanta, Georgia, United States
- Children's Hospital of Chicago — Chicago, Illinois, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Boston Children's Hospital — Boston, Massachusetts, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Saint Barnabas Medical Center — Livingston, New Jersey, United States
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Cook Children's Medical Center — Fort Worth, Texas, United States
- University of Utah — Salt Lake City, Utah, United States
- Seattle Children's Hospital — Seattle, Washington, United States
- MultiCare Institute for Research & Innovation — Tacoma, Washington, United States
- Melbourne Brain Centre Austin Hospital — Melbourne, Australia
- Children's Health Queensland Hospital and Health Service at Lady Cilento Children's Hospital — South Brisbane, Australia
- The Children's Hospital Westmead Dept. of Neurology and Neurosurgery — Westmead, Australia
- Universitair Ziekenhuis Antwerpen — Antwerp, Belgium
- British Columbia Children's Hospital BCCH — Vancouver, British Columbia, Canada
- Centre Hospitalier Universitaire Sainte-Justine — Montreal, Canada
- Phoenix Children's — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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