A Study of BIIB067 (Tofersen) Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

May 17, 2021

Primary Completion Date

August 7, 2027

Study Completion Date

August 7, 2027

Conditions
Amyotrophic Lateral Sclerosis Associated With a SOD1 Gene Mutation
Interventions
DRUG

Tofersen

Administered as specified in the treatment arm

DRUG

Placebo

Administered as specified in the treatment arm

Trial Locations (29)

2109

Macquarie University, Sydney

3000

UZ Leuven, Leuven

4763

Hanyang University Seoul Hospital, Seoul

10032

Columbia University Medical Center, New York

10124

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino

21287

Johns Hopkins Hospital, Baltimore

30625

Medizinische Hochschule Hannover, Hanover

33136

University of Miami School of Medicine, Miami

33308

Holy Cross Hospital Phil Smith Neuroscience Institute, Fort Lauderdale

46026

Hospital Universitari i Politecnic La Fe, Valencia

60611

Northwestern Medicine, Chicago

63110

Washington University School of Medicine, St Louis

75651

Groupe Hospitalier Pitie-Salpetriere, Paris

78756

Austin Neuromuscular Center, Austin

85251

HonorHealth Neurology, Scottsdale

89081

Universitaetsklinikum Ulm, Ulm

90185

University Hospital of Umea, Umeå

94107

California Pacific Medical Center Research Institute, San Francisco

92093-0949

University of California San Diego Medical Center, La Jolla

30322-4200

The Emory Clinic, Atlanta

02129

Massachusetts General Hospital, Charlestown

04037-002

Hospital Sao Paulo, São Paulo

T2N 4Z6

University of Calgary, Calgary

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

H4A 3T2

Genge Partners Inc., Montreal

890-8520

Kagoshima University Hospital, Kagoshima

113-8655

University of Tokyo Hospital, Bunkyō City

01-684

NeuroProtect Sp. z o.o., Warsaw

S10 2RX

University of Sheffield, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biogen

INDUSTRY