Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E)

Stopped early · Phase 3

Conditions studied: Duchenne Muscular Dystrophy

In brief

The purpose of the study is to assess the long-term safety and efficacy of idebenone in patients with Duchenne muscular dystrophy (DMD) who completed the SIDEROS study.

Key facts

Study ID

NCT03603288

Run by

Santhera Pharmaceuticals

People needed

161

Starts

2018-07-04

Expected to finish

2020-11-25

Last updated by the study team

2021-12-03

Who can join

Age: 11 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Completion of the SIDEROS study at Visit 8/ Week 78
• Signed and dated Informed Consent Form for SIDEROS-E

You may not qualify if…

• Patients who discontinued SIDEROS study prematurely (i.e. did not attend all visits from V1 to V8)
• Safety, tolerability or other issues arising during the course of the SIDEROS study which in the opinion of the Investigator may put the patient at significant risk or may interfere significantly with the patient's participation in the SIDEROS-E study
• Use of any investigational drug other than the study medication

Where it is running

• University of Alabama - Birmingham, Child Health Research — Birmingham, Alabama, United States
• Banner University of Arizona Medical Center — Tucson, Arizona, United States
• Children's Hospital of Los Angeles — Los Angeles, California, United States
• UC Davis Department of Physical Medicine and Rehabilitation — Sacramento, California, United States
• Center for Integrative Rare Disease Research, Rare Disease Research, LLC — Atlanta, Georgia, United States
• University of Iowa, Department of Pediatrics — Iowa City, Iowa, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Children's Hospital Boston, Harvard Medical School, Department of Neurology — Boston, Massachusetts, United States
• Gillette Children's Specialty Healthcare — Saint Paul, Minnesota, United States
• Neurosciences Institute, Neurology - Charlotte Carolinas Healthcare System — Charlotte, North Carolina, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Children's Hospital of Philadelphia, Division of Pulmonology — Philadelphia, Pennsylvania, United States
• Gottfried von Preyer'sches Kinderspital — Vienna, Austria
• University Hospital Leuven — Leuven, Belgium
• CHR Citadelle — Liège, Belgium
• Service de neuropédiatrie Pôle Pédiatrie CHRU de Lille - Hôpital Jeanne de Flandre — Lille, France
• CHRU de Montpellier - Hôpital Gui de Chauliac, Département de pédiatrie - neuropédiatrie — Montpellier, France
• Hôpital Hôtel Dieu, Service Explorations Fonctionnelles - Centre de Référence de Maladies Neuromusculaires rares — Nantes, France
• I-Motion - Plateforme d'essais cliniques pédiatriques Hôpital Armand Trousseau bâtiment Lemariey porte 20, 2ème étage — Paris, France
• Hôpital des enfants, Pédiatrie Neurologie et infectiologie Pôle enfants — Toulouse, France
• University Medical Center Hamburg - Eppendorf, Department of Paediatrics — Hamburg, Germany
• Center for neuromuscular disorders, Dr. v. Haunersche Kinderklinik, Universität München — München, Germany
• Fondazione IRCCS Eugenio Medea — Bosisio Parini, Italy
• U.O. Malattie Neuromuscolari, Istituto Giannina Gaslini — Genova, Italy

Full record on ClinicalTrials.gov

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