Long-term safety monitoring of tofersen (Qalsody) in people with SOD1 ALS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational effort collects safety and clinical data on people with SOD1-ALS who are captured in two contributing registry networks (Precision-ALS in Europe and the ALS/Motor Neuron Disease Natural History Consortium in the United States). The study focuses on documenting serious adverse events, including neurologic events reported in prior tofersen trials (for example myelitis, radiculitis, aseptic meningitis, raised intracranial pressure, or papilledema), as well as new comorbidities, pregnancy outcomes, and treatment discontinuation. Data already began to accrue in the NHC registry while TRICALS collection is pending. Information from participating centers such as Mass General Hospital will be pooled without changing routine clinical care, and data collected during other interventional trials are excluded.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

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

Key Exclusion Criteria:

* 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.

NOTE: Other protocol- defined Inclusion/Exclusion criteria may apply.

Where it's running

• Mass General Hospital -MGH
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Study US Biogen Clinical Trial Center
• Email: clinicaltrials@biogen.com
• Phone: 866-633-4636

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.