Phase III Study of Idebenone in Duchenne Muscular Dystrophy (DMD)

PHASE3CompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

July 31, 2009

Primary Completion Date

January 31, 2014

Study Completion Date

April 30, 2014

Conditions
Muscular Dystrophy, DuchenneAmbulatory Care
Interventions
DRUG

Placebo

Placebo (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals

DRUG

Idebenone

Idebenone (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals

Trial Locations (23)

1011

CHUV Lausanne Neuropediatrie, Lausanne

1100

Dr. Günther Bernert, Prim. Univ. Doz., Vienna

17176

Prof. Thomas Sejersen, MD, PhD, Stockholm

23842

"Fondazione IRCCS Eugenio Medea", Bosisio Parini, Lecco

28041

Hospital Universitario 12 de Octubre, Madrid

28207

Carolinas Medical Center, Neurosciences and Spine Institute, Charlotte

32610

University of Florida, Gainesville

37232

Monroe Carell, Jr. Children's Hospital at Vanderbilt, Nashville

46009

Hospital Universitario y Politécnico La Fe, Valencia

59037

Hôpital Roger Salengro, CHRU Lille, Lille

75651

Prof. Thomas Voit , MD, PhD, Paris

77030

Methodist Neurological Institute, Houston

79106

Universitätsklinik Freiburg Zentrum für Kinderheilkunde und Jugendmedizin, Freiburg im Breisgau

80045

Children's Hospital Colorado, Aurora

80138

Azienda Ospedaliera Universitaria della Seconda Università degli Studi di Napoli, Napoli

95817

University of California Davis Medical Center, Sacramento

98105

Seattle Children's Hospital, Seattle

19104-1771

The Children's Hospital of Philadelphia, Philadelphia

75390-9105

University of Texas Southwestern Medical Center, Dallas

B - 3000

University Hospitals Leuven- Children Hospital, Leuven

D-45122

Universitätsklinikum Essen, Zentrum für Kinderheikunde, Essen

20162,

Azienda Ospedaliera Niguarda Ca' Granda Centro Clinico Nemo, Milan

2300 RC

Ass. Prof. Jan Verschuuren , MD, PhD, Leiden

Sponsors
All Listed Sponsors
lead

Santhera Pharmaceuticals

INDUSTRY

NCT01027884 - Phase III Study of Idebenone in Duchenne Muscular Dystrophy (DMD) | Biotech Hunter | Biotech Hunter