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Observational Study of Tofersen (Qalsody) Safety in SOD1-ALS

This study, called an "observational" study, aims to learn more about the long-term safety of a drug called tofersen (also known as Qalsody®). Tofersen is a prescription medication for people with a specific type of amyotrophic lateral sclerosis (ALS), which is caused by a change (mutation) in the SOD1 gene. Researchers will collect health information from people with SOD1-ALS to understand the drug's safety without changing their medical care. The study will look at things like age, sex, and ethnicity, as well as any serious side effects or new health conditions. Participants will be identified through existing ALS research networks. Data collection has started with one group, and another group is yet to begin.

Study design
This is an observational study, meaning it collects health information without changing medical care. It plans to include 125 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07259980

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)

Recruiting
Not specifiedAges 18+Observational
Biogen
~125 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:Tofersen

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Baseline Demographic: Age
Measured over At Baseline
+15 more outcomes measured

Conditions

Amyotrophic Lateral Sclerosis

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NCT07259980

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mass General Hospital -MGH

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Medical Director · STUDY_DIRECTOR · Biogen

Who to contact

Study US Biogen Clinical Trial Center
[email protected]
866-633-4636
Email the study team

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Eligibility criteria

Inclusion

Participants with an ALS diagnosis and a confirmed SOD1 mutation from contributing registry networks will be considered for inclusion in the study.

Exclusion

Data collected while a person with SOD1-ALS is participating in an interventional clinical trial (with tofersen or any other investigational medicinal product) will be excluded.

What this trial measures

  • Baseline Demographic: AgeAt Baseline
  • Baseline Demographic: Participant SexAt Baseline
  • Baseline Demographic: Race/EthnicityAt Baseline
  • Baseline Demographic: WeightAt Baseline
  • Baseline Demographic: HeightAt Baseline
  • Baseline Demographic: Body Mass Index (BMI)At Baseline
  • Baseline Demographic: Family History of Amyotrophic Lateral Sclerosis (ALS)At Baseline
  • Clinical Characteristics: Age at Diagnosis and Symptom OnsetAt Baseline
  • Clinical Characteristics: Revised El Escorial ClassificationAt Baseline
  • Clinical Characteristics: Classification of SOD1-ALS Clinical PhenotypesAt Baseline
  • Clinical Characteristics: SOD1 Mutation TypeAt Baseline
  • Clinical Characteristics: Medical HistoryAt Baseline
  • Clinical Characteristics: Concomitant MedicationsAt Baseline
  • Clinical Characteristics: Disease HistoryAt Baseline
  • Clinical Characteristics: Pregnancy StatusAt Baseline
  • Number of Participants With Serious Adverse EventsUp to 7 years