A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Participants With Superoxide Dismutase 1 (SOD-1) Amyotrophic Lateral Sclerosis (ALS)
← catalyst calendarNCT07259980 · readout in 2,690 d
Sponsored by Biogen (industry) · BIIB — their whole pipeline →.
Phase
—
Status
Recruiting
Study type
Observational
Enrollment
125estimated
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-01-02 | actual | When the study began enrolling |
| Primary completion | 2033-12-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2033-12-30 | estimated | The whole study's end, after follow-up |
| First posted | 2025-12-02 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-09 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Amyotrophic Lateral Sclerosis
Intervention
- Drug: Tofersen — also filed as BIIB067, Qalsody
Primary outcomes
what the primary-completion date above is the date OFBaseline Demographic: Age
measured At Baseline
Baseline Demographic: Participant Sex
measured At Baseline
Baseline Demographic: Race/Ethnicity
measured At Baseline
Baseline Demographic: Weight
measured At Baseline
Baseline Demographic: Height
measured At Baseline
Baseline Demographic: Body Mass Index (BMI)
measured At Baseline
Baseline Demographic: Family History of Amyotrophic Lateral Sclerosis (ALS)
measured At Baseline
Clinical Characteristics: Age at Diagnosis and Symptom Onset
measured At Baseline
Clinical Characteristics: Revised El Escorial Classification
measured At Baseline
Clinical Characteristics: Classification of SOD1-ALS Clinical Phenotypes
measured At Baseline
Clinical Characteristics: SOD1 Mutation Type
measured At Baseline
Clinical Characteristics: Medical History
measured At Baseline
Clinical Characteristics: Concomitant Medications
measured At Baseline
Clinical Characteristics: Disease History
measured At Baseline
Clinical Characteristics: Pregnancy Status
measured At Baseline
Number of Participants With Serious Adverse Events
measured Up to 7 years
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