A Phase III Double-blind Study With Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Taking Glucocorticoid Steroids

PHASE3TerminatedINTERVENTIONAL
Enrollment

255

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

December 1, 2020

Study Completion Date

December 1, 2020

Conditions
Duchenne Muscular Dystrophy (DMD)
Interventions
DRUG

Idebenone 150 mg film-coated tablets

DRUG

placebo

Trial Locations (63)

1

Children's University Hospital, Dublin

1100

Gottfried von Preyer'sches Kinderspital, Vienna

1431

Sofia Medical University, Sofia

3000

University Hospital Leuven, Leuven

4000

Centre de Référence Neuromusculaire, CHR Citadelle, Liège

4301

Center for neuromuscular disorders, Universitäts-Kinderspital beider Basel (UKBB), Basel

6500

Radboud university medical centre, Nijmegen

8950

Hospital Universitari Vall D' Hebron, Barcelona

13353

Universitätsmedizin Berlin Campus Virchow-Klinikum, Berlin

14642

University of Rochester Medical Center, Rochester

16147

Istituto Giannina Gaslini, Genova

20246

Universitätsklinikum Hamburg-Eppendorf, Klinik für Kinder- und Jugendmedizin, Hamburg

21287

Johns Hopkins University, Baltimore

23842

Fondazione IRCCS Eugenio Medea, Bosisio Parini

27100

"Dipartimento di Clinica Neurologica e Psichiatrica dell'Età Evolutiva della Fondazione IRCCS C. Mondino di Pavia", Pavia

28046

Hospital Universitario La Paz, Madrid

28207

Neurosciences Institute, Neurology - Charlotte Carolinas Healthcare System, Charlotte

30318

Rare Disease Research, Atlanta

31059

Hôpital des enfants, Toulouse

33612

Shriners Hospitals for Children-Tampa, Tampa

34295

CHRU de Montpellier - Hôpital Gui de Chauliac, Montpellier

35122

Reparto Di Neurologia dell'Osperdale Di Padova, Padua

35233

University of Alabama, Birmingham

41013

Hospital Universitario Virgen del Rocio, Seville

44093

Hôpital Hôtel Dieu, Nantes

45147

Universitätsklinikum Essen, Essen

50937

Uniklinik Köln, Cologne

52242

University of Iowa, Iowa City

55101

Gillette Children's Specialty Healthcare, Saint Paul

59037

Service de neuropédiatrie Pôle Pédiatrie CHRU de Lille - Hôpital Jeanne de Flandre, Lille

66103

University of Kansas, Fairway

76087

Cook Children's Medical Center, Fort Worth

80131

"Servizio di Cardiomiologia e Genetica Medica, AOU Università degli Studi della Campania Luigi Vanvitelli", Napoli

85016

Phoenix Children's Hospital, Phoenix

85724

Banner University of Arizona Medical Center, Tucson

90027

Childrens Hospital of Los Angeles, Los Angeles

90095

David Geffen School of Medicine at UCLA, Los Angeles

92354

Loma Linda University Healthcare, San Bernardino

95817

UC Davis Department of Physical Medicine and Rehabilitation, Sacramento

98125

Scientific Coordinator Nemo Sud Clinical Center, Messina

4920235

Institute of Neurology at Schneider Children's Medical Center of Israel, Petah Tikva

02115

Children's Hospital Boston, Boston

45229-3039

Cincinnati Children's Hospital, Cincinnati

44109-1988

MetroHealth Medical Center, Cleveland

19104-1771

Children's Hospital of Philadelphia, Philadelphia

Unknown

I-Motion - Plateforme d'essais cliniques pédiatriques Hôpital Armand Trousseau bâtiment Lemariey porte 20, Paris

Universitätsklinik Freiburg Zentrum für Kinderheilkunde und Jugendmedizin, Freiburg im Breisgau

Universitätsklinikum Heidelberg Zentrum für Kinder- und Jugendmedizin, Heidelberg

Zentrum für neuromuskuläre Erkrankungen, München

Semmelweis University 2nd Department of Paediatrics, Budapest

Centro Clinico NEMO (NEuroMuscular Omnicentre), Niguarda Hospital, Milan

LUMC, Leiden

Sahlgrenska University Hospital, Gothenburg

John Walton Muscular Dystrophy Research Centre, Newcastle

00168

U.O.C. Neuropsichiatria Infantile, Roma

08950

Hospital Sant Joan de Déu Neuropediatra, Barcelona

106 46026

Hospital La Fe de Valencia, Valencia

LS1 3EX

Leeds Teaching Hospital NHS Trust, Leeds

WC1 3BG

UCL, National Hospital for Neurology and Neurosurgery, London

WC1N 3JH

Great Ormond Street Hospital for Children, London

SY10 7AG

Robert Jones and Agnes Hunt Orthopaedic Hospital, Oswestry

OX39DU

Oxford University hospitals NHS Foundation Trust, Oxford

S10 2JF

Royal Hallamshire Hospital, Sheffield

Sponsors
All Listed Sponsors
lead

Santhera Pharmaceuticals

INDUSTRY

NCT02814019 - A Phase III Double-blind Study With Idebenone in Patients With Duchenne Muscular Dystrophy (DMD) Taking Glucocorticoid Steroids | Biotech Hunter | Biotech Hunter