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

PHASE3TerminatedINTERVENTIONAL
Enrollment

161

Participants

Timeline

Start Date

July 4, 2018

Primary Completion Date

November 25, 2020

Study Completion Date

November 25, 2020

Conditions
Duchenne Muscular Dystrophy
Interventions
DRUG

idebenone 150 mg film-coated tablets

900 mg idebenone/day

Trial Locations (39)

1100

Gottfried von Preyer'sches Kinderspital, Vienna

3000

University Hospital Leuven, Leuven

4000

CHR Citadelle, Liège

4301

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

16147

U.O. Malattie Neuromuscolari, Istituto Giannina Gaslini, Genova

20162

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

20246

University Medical Center Hamburg - Eppendorf, Department of Paediatrics, Hamburg

21287

Johns Hopkins University, Baltimore

23842

Fondazione IRCCS Eugenio Medea, Bosisio Parini

27100

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

28207

Neurosciences Institute, Neurology - Charlotte Carolinas Healthcare System, Charlotte

30318

Center for Integrative Rare Disease Research, Rare Disease Research, LLC, Atlanta

31059

Hôpital des enfants, Pédiatrie Neurologie et infectiologie Pôle enfants, Toulouse

34295

CHRU de Montpellier - Hôpital Gui de Chauliac, Département de pédiatrie - neuropédiatrie, Montpellier

35122

Reparto Di Neurologia dell'Osperdale Di Padova, Padua

35233

University of Alabama - Birmingham, Child Health Research, Birmingham

44093

Hôpital Hôtel Dieu, Service Explorations Fonctionnelles - Centre de Référence de Maladies Neuromusculaires rares, Nantes

45229

Cincinnati Children's Hospital, Cincinnati

46026

Hospital La Fe de Valencia Avinguda de Fernando Abril Martorell Servicio de Neurologia Torre D, Valencia

52242

University of Iowa, Department of Pediatrics, Iowa City

55101

Gillette Children's Specialty Healthcare, Saint Paul

59037

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

75571

I-Motion - Plateforme d'essais cliniques pédiatriques Hôpital Armand Trousseau bâtiment Lemariey porte 20, 2ème étage, Paris

80131

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

80337

Center for neuromuscular disorders, Dr. v. Haunersche Kinderklinik, Universität München, München

85724

Banner University of Arizona Medical Center, Tucson

90027

Children's Hospital of Los Angeles, Los Angeles

95817

UC Davis Department of Physical Medicine and Rehabilitation, Sacramento

98125

"Scientific Coordinator Nemo Sud Clinical CenterAOU Policlinico G. Martino", Messina

02115

Children's Hospital Boston, Harvard Medical School, Department of Neurology, Boston

44109-1988

MetroHealth Medical Center, Cleveland

19104-1771

Children's Hospital of Philadelphia, Division of Pulmonology, Philadelphia

00168

U.O.C. Neuropsichiatria Infantile, Roma

08950

Hospital Sant Joan de Deu Neuropediatra, Unidad de patologia nueromuscular, Servicio de Neurologia, Barcelona

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

NE1 4LP

Clinical Research Facility Level 6 Leazes Wing Royal Victoria Infirmary, Newcastle upon Tyne

SY10 7AG

Robert Jones and Agnes Hunt Orthopaedic Hospital, Oswestry

Sponsors
All Listed Sponsors
lead

Santhera Pharmaceuticals

INDUSTRY

NCT03603288 - Phase III Study With Idebenone in Patients With Duchenne Muscular Dystrophy (SIDEROS-E) | Biotech Hunter | Biotech Hunter