Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys With DMD (RACER53)

PHASE3CompletedINTERVENTIONAL
Enrollment

77

Participants

Timeline

Start Date

April 14, 2020

Primary Completion Date

October 19, 2023

Study Completion Date

October 19, 2023

Conditions
Duchenne Muscular Dystrophy
Interventions
DRUG

Viltolarsen

IV infusion

DRUG

Placebo

IV infusion

Trial Locations (40)

60611

Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago

95817

University of California Davis Medical Center, Sacramento

Unknown

Queensland Children's Hospital, Brisbane

Perth Children's Hospital, Nedlands

The Childrens Hospital at Westmead, Westmead

The Hospital for Sick Children (SickKids), Toronto

Alberta Children's Hospital, Calgary

CHU de Quebec Research Centre, Québec

Hospital de Niños Roberto del Rio, Santiago

Pontificia Universidad Católica de Chile, Santiago

Chinese PLA General Hospital, Beijing

The Third Medical Center of PLA General Hospital, Beijing

Hunan Children's Hospital, Changsha

Children's Hospital of Fudan University, Shanghai

Shenzhen Children's Hospital, Shenzhen

Agia Sofia Children's Hospital, Athens

Hippokration General Hospital of Thessaloniki, Thessaloniki

Hong Kong Children's Hospital, Kowloon Bay

Fondazione Policlinico Universitario A. Gemelli - Universita Cattolica del Sacro Cuore, Rome

Hospital Angeles Chihuahua, Chihuahua City

Instituto Nacional de Pediatria, Mexico City

Radboud Universitair Medisch Centrum, Nijmegen

Leids Universitair Medisch Centrum, Leiden

New Zealand Clinical Research Ltd, Auckland

Rikshospitalet, Oslo

Russian National Research Medical University n.a. N.I.Pirogov, structural branch - Research Clinical Institute of Pediatrics n.a. Academician Yu. E. Veltishchev, Moscow

"Saint Petersburg State Paediatric Medical University based at Consultative and Diagnostic Centre", Saint Petersburg

Tomsk National Research Medical Center of Russian Academy of Sciences, Tomsk

Pusan National University Yangsan Hospital, Pusan

Seoul National University Hospital, Seoul

Hospital Sant Joan de Deu, Barcelona

Hospital Universitario La Paz, Madrid

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

National Taiwan University Hospital, Taipei

Yeditepe University Kosuyolu Hospital, Istanbul

"State Institution Ukrainian Medical rehabilitation Center for Children with organic disorders of the nervous system of the Ministry of Health of Ukraine", Kyiv

Birmingham Heartlands Hospital, Birmingham

Royal Hospital for Children - Glasgow, Glasgow

University College London Institute of Child Health, London

Royal Manchester Children's Hospital, Manchester

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Nippon Shinyaku Co., Ltd.

INDUSTRY

lead

NS Pharma, Inc.

INDUSTRY

NCT04060199 - Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys With DMD (RACER53) | Biotech Hunter | Biotech Hunter