A Study of Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia (FRDA) Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

232

Participants

Timeline

Start Date

April 30, 2006

Primary Completion Date

January 31, 2010

Study Completion Date

January 31, 2010

Conditions
Friedreich's Ataxia
Interventions
DRUG

idebenone

12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.

DRUG

Placebo

12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.

Trial Locations (13)

1070

Hôpital Erasme - Université Libre de Bruxelles, Brussels

6020

Universitätsklinik Innsbruck, Innsbruck

13125

HELIOS Klinikum BerlinBuch, Berlin

20246

UKE Hamburg Neuropädiatrie-Zentum für Frauen, Kinder und Jugendmedizin, Hamburg

37073

Zentrum für Neurologische Medizin, Göttingen

53105

Neurologische Universitätsklinik und Poliklinik- Universitätsklinikum Bonn, Bonn

72076

Neurologische Universitätsklinik und Poliklinik, Tübingen

75651

Hôpital de la Salpêtrière - INSERM U679, Neurologie et Thérapeutique expérimentale, Paris

79106

Klinik II, Neuropädiatrie u.Muskelerkrankungen- Universitätsklinik Freiburg, Freiburg im Breisgau

81377

Neurologische Klinik- klinikum Grosshadern, München

9700 RB

University Medical Center Groningen, Groningen

WC1N 3BG

National Hospital for Neurology & Neurosurgery, London

NE2 4HH

University of Newcastle upon Tyne -Mitochondrial Research Group, Newcastle

Sponsors
All Listed Sponsors
lead

Santhera Pharmaceuticals

INDUSTRY

NCT00905268 - A Study of Efficacy, Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia (FRDA) Patients | Biotech Hunter | Biotech Hunter