A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome

Completed · Phase 3 · Has a placebo group

Conditions studied: Lennox Gastaut Syndrome

In brief

This is a two-part, multicenter, double-blind, parallel-group, placebo controlled study to evaluate the effect of ZX008 when used as adjunctive therapy for the treatment of uncontrolled seizures in children and adults with Lennox-Gastaut syndrome (LGS).

Key facts

Study ID

NCT03355209

Run by

Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

People needed

296

Starts

2017-11-27

Expected to finish

2024-05-23

Last updated by the study team

2025-07-03

Who can join

Age: 2 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Ep0214 144 — Los Angeles, California, United States
• Ep0214 101 — San Francisco, California, United States
• Ep0214 103 — Aurora, Colorado, United States
• Ep0214 149 — Washington D.C., District of Columbia, United States
• Ep0214 115 — Gulf Breeze, Florida, United States
• Ep0214 104 — Miami, Florida, United States
• Ep0214 141 — Orlando, Florida, United States
• Ep0214 121 — Orlando, Florida, United States
• Ep0214 117 — Atlanta, Georgia, United States
• Ep0214 110 — Chicago, Illinois, United States
• Ep0214 140 — Bethesda, Maryland, United States
• Ep0214 112 — Boston, Massachusetts, United States
• Ep0214 136 — Grand Rapids, Michigan, United States
• Ep0214 147 — Royal Oak, Michigan, United States
• Ep0214 109 — Rochester, Minnesota, United States
• Ep0214 132 — Saint Paul, Minnesota, United States
• Ep0214 105 — Hackensack, New Jersey, United States
• Ep0214 118 — Livingston, New Jersey, United States
• Ep0214 150 — Hartsdale, New York, United States
• Ep0214 142 — New York, New York, United States
• Ep0214 131 — Cleveland, Ohio, United States
• Ep0214 143 — Portland, Oregon, United States
• Ep0214 120 — Philadelphia, Pennsylvania, United States
• Ep0214 139 — York, Pennsylvania, United States
• Ep0214 107 — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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