ClinicalTrials.gov record
Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT04856982

Public ClinicalTrials.gov record NCT04856982. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 8, 2026, 5:03 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3 Randomized, Placebo-Controlled Trial With a Longitudinal Natural History Run-In and Open-Label Extension to Evaluate BIIB067 Initiated in Clinically Presymptomatic Adults With a Confirmed Superoxide Dismutase 1 Mutation

Study identification

NCT ID
NCT04856982
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Biogen
Industry
Enrollment
158 participants

Conditions and interventions

Interventions

  • Placebo Drug
  • Tofersen Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 16, 2021
Primary completion
Aug 6, 2027
Completion
Apr 29, 2028
Last update posted
Mar 29, 2026

2021 – 2028

United States locations

U.S. sites
12
U.S. states
10
U.S. cities
12
Facility City State ZIP Site status
HonorHealth Neurology Scottsdale Arizona 85258
University of California San Diego Medical Center La Jolla California 92093-0949
California Pacific Medical Center Research Institute San Francisco California 94107
Holy Cross Hospital Fort Lauderdale Florida 33308
University of Miami School of Medicine Miami Florida 33136
The Emory Clinic Atlanta Georgia 30322-4200
Northwestern Medicine Chicago Illinois 60611
Johns Hopkins Hospital Baltimore Maryland 21287
Massachusetts General Hospital, MA Charlestown Massachusetts 02129
Washington University School of Medicine St Louis Missouri 63110
Columbia University Medical center New York New York 10032
Austin Neuromuscular Center Austin Texas 78756

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 20 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04856982, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 29, 2026 · Synced May 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04856982 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →