An Efficacy, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BIIB067 (Tofersen) in Adults With Inherited Amyotrophic Lateral Sclerosis (ALS)

PHASE3CompletedINTERVENTIONAL
Enrollment

176

Participants

Timeline

Start Date

January 20, 2016

Primary Completion Date

July 16, 2021

Study Completion Date

July 16, 2021

Conditions
Amyotrophic Lateral Sclerosis
Interventions
DRUG

Tofersen

Administered as specified in the treatment arm.

DRUG

Placebo

Administered as specified in the treatment arm.

Trial Locations (40)

2145

Westmead Hospital, Westmead

2400

Bispebjerg Hospital, Copenhagen

3000

UZ Leuven, Leuven

10032

Columbia University Medical Center, New York

10126

"ALS Center - Dept. of Neuroscience Rita Levi Montalcini, University of Turin", Torino

19104

University of Pennsylvania, Philadelphia

21287

Johns Hopkins University, Baltimore

30322

Emory University Hospital, Atlanta

32224

Mayo Clinic in Florida, Jacksonville

32806

Bioclinica Research, Orlando

33136

University of Miami School of Medicine, Miami

37920

New Orleans Center for Clinical Research/Volunteer Research Group, an AMR Company, Knoxville

44106

The Cleveland Clinic Foundation, Cleveland

48202

Henry Ford Hospital, Detroit

50612

Research Site, Yangsan

55905

Mayo Clinic - Rochester, Rochester

60611

Northwestern University Feinberg School of Medicine, Chicago

63110

Washington University School of Medicine, St Louis

68506

Neurology Associates, P.C., Lincoln

75651

Hopital Pitie Salpetriere, Paris

77030

Methodist Neurological Institute, Houston

85013

Barrow Neurological Institute, Phoenix

89081

University of Ulm, Ulm

92093

University of California San Diego Medical Center, La Jolla

94115

California Pacific Medical Center, San Francisco

97213

Providence ALS Center, Portland

02114

Massachusetts General Hospital, Boston

T2N 1N4

University of Calgary - Health Sciences Centre, Calgary

T6G 2G3

Research Site, Edmonton

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

H3A 2B4

Montreal Neurological Institute, Montreal

Unknown

The University of Tokyo Hospital, Bunkyō City

Research Site, Fukuoka

Research Site, Kagoshima

Research Site, Shinjuku-ku

Research Site, Suita-Shi

01684

Research Site, Warsaw

04763

Research Site, Seoul

SE5 9RS

Research Site, London

S10 2HQ

Research Site, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Ionis Pharmaceuticals, Inc.

INDUSTRY

lead

Biogen

INDUSTRY