A 2-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children ≥ 2 Years Old and Young Adults With Dravet Syndrome
Completed · Phase 3 · Has a placebo group
Conditions studied: Dravet Syndrome
In brief
The primary purpose of this study is to evaluate the safety, tolerability, and efficacy of ZX008 (fenfluramine hydrochloride) when added to adjunctive antiepileptic stiripentol treatment in children and young adults with Dravet syndrome.
Key facts
- Study ID
- NCT02926898
- Run by
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
- People needed
- 87
- Starts
- 2017-01-27
- Expected to finish
- 2018-06-05
- Last updated by the study team
- 2022-11-02
Who can join
Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of California San Francisco — San Francisco, California, United States
- Children'S Hospital Colorado — Aurora, Colorado, United States
- Ann & Robert H. Lurie Children'S Hospital of Chicago — Chicago, Illinois, United States
- Children'S Hospital of Michigan — Detroit, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Bc Children'S Hospital Division of Neurology — Vancouver, British Columbia, Canada
- Chu Sainte-Justine Hospital Neurology Clinic — Montreal, Quebec, Canada
- Chu Amiens Picardie Service de Neurologie Pédiatrique — Amiens, France
- Chu de Bordeaux Hôpital Des Enfants — Bordeaux, France
- HÔPITAL FEMME-MÈRE-ENFANT Hôpital Service de Neurologie Pédiatrique — Bron, France
- Chru de Lille Hôpital Roger Salengro — Lille, France
- Hôpital de La Timone, Service de Neuro-Métabolisme Pédiatrique — Marseille, France
- Hôpital Necker-Enfants Malades — Paris, France
- Hôpital Robert-Debré — Paris, France
- Chu de Toulouse - Hôpital Des Enfants — Toulouse, France
- Hôpital D'Enfants Chur de Nancy — Vandœuvre-lès-Nancy, France
- Krankenhaus Mara, Epilepsie-Zentrum Bethel — Bielefeld, Germany
- Universitätsklinikum Schleswig-Holstein, Klinik Für Neuropädiatrie — Kiel, Germany
- Kleinwachau Sächsisches Epilepsiezentrum Radeberg — Radeberg, Germany
- Epilepsiecentrum Kempenhaeghe — Heeze, Netherlands
- Stichting Epilepsie Instellingen Nederland — Zwolle, Netherlands
- Hospital Sant Joan de Déu Barcelona — Barcelona, Spain
- Hospital Ruber Internacional-Servicio de Neurología — Madrid, Spain
- Cliníca Universidad de Navarra Nidad de Neuropediatría — Pamplona, Spain
- Royal Hospital For Children, Queen Elizabeth University, Institute of Neurosciences Hospital — Glasgow, Scotland, United Kingdom
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.