A Study to Learn About the Effect of Higher Doses of Nusinersen (BIIB058) Given as Injections to Participants With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Risdiplam (ASCEND)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

January 21, 2022

Primary Completion Date

June 14, 2027

Study Completion Date

June 14, 2027

Conditions
Spinal Muscular Atrophy
Interventions
DRUG

Nusinersen

Administered as specified in the treatment arm

Trial Locations (44)

165

Ospedale Pediatrico Bambino Gesù, Rome

168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma

1085

Semmelweis Egyetem, Budapest

3000

UZ Leuven, Leuven

8950

Hospital Sant Joan de Deu, Esplugues de Llobregat

9000

UZ Gent, Ghent

10032

Columbia University, New York

10126

Ospedale S G Battista Molinette, Torino

13353

Charité - Campus Virchow-Klinikum, Berlin

19104

University of Pennsylvania, Philadelphia

20037

Georgetown University, Washington D.C.

20133

Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan

20162

Fondazione Serena Onlus - Centro Clinico Nemo, Milan

23507

Children's Hospital of The King's Daughters, Norfolk

27157

Wake Forest University - School of Medicine - Central, Winston-Salem

30329

Rare Disease Research, LLC, Atlanta

35392

Universitaetsklinikum Giessen und Marburg GmbH, Giessen

43210

The Ohio State, Columbus

45122

Universitaetsklinikum Essen, Essen

45147

Universitaetsklinikum Essen, Essen

46026

Hospital Universitari i Politecnic La Fe, Valencia

48867

Memorial Healthcare, Owosso

52242

University of Iowa Stead Family Children's Hospital, Iowa City

53792

University of Wisconsin, Madison

69120

Universitaetsklinikum Heidelberg, Heidelberg

72202

Arkansas Children's Hospital, Little Rock

76208

Neurology Rare Disease Center, Denton

77030

The University of Texas Health Science Center at Houston, Houston

81675

Klinikum rechts der Isar der TU Muenchen, Munich

85013

Barrow Neurological Institute, Phoenix

89081

Universitaetsklinikum Ulm, Ulm

92354

Loma Linda University Children's Hospital, Loma Linda

94304

Stanford Neuroscience Health Center, Palo Alto

98195

University of Washington Medical Center, Seattle

5403900

Hospital das Clinicas - FMUSP, São Paulo

60611-2605

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

02115-5724

Boston Children's Hospital, Boston

90035-903

Hospital de Clínicas de Porto Alegre, Porto Alegre

236-0004

Yokohama City University Hospital, Yokohama

560-8552

NHO Osaka Toneyama Medical Center, Toyonaka-shi

31-826

Szpital Specjalistyczny im. L.Rydygiera w Krakowie, Krakow

93-338

Instytut Centrum Zdrowia Matki Polki, Lodz

02-091

Samodzielny Publiczny Centralny Szpital Kliniczny, Warsaw

50-556

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu, Wroclaw

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biogen

INDUSTRY