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Study identifier: NCT07259980 Synced from ClinicalTrials.gov · July 28, 2026
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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)

Condition: Amyotrophic Lateral Sclerosis  ·  Sponsor: Biogen

PhaseN/A
Planned participants125
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

In this study, researchers will learn more about the safety of tofersen, also known as Qalsody®. This is a drug available for doctors to prescribe for participant with a certain type of amyotrophic lateral sclerosis, also known as ALS. This type is in participant who have a mutation in the superoxide dismutase 1 gene, also known as SOD-1. This is known as an "observational" study, which collects health information about study participants without changing their medical care. Participants for this study will be found using 2 different groups of study research centers that help provide clinical care for participant with ALS. These groups are in Europe and the United States and are called: * the Precision-ALS programme * the ALS/Motor Neuron Disease (MND) Natural History Consortium (NHC) The main goal of this study is to collect safety information in participants with SOD-1 ALS who were in either of the groups. The main question researchers want to answer in this study is: * What are the characteristics of the participants in this study? * How many participants had serious adverse events (SAEs), including ones that affect the brain, spinal cord, or nerves? An adverse event is a health problem that may or may not be caused by a drug during the study. An adverse event is considered serious when it results in death, is life-threatening, causes lasting problems, or requires hospital care. Researchers will also learn more about: * How many participants develop other health co…

This description comes directly from the study's public registry record.

Talk to the study team

Study US Biogen Clinical Trial Center  ·  866-633-4636  ·  clinicaltrials@biogen.com

Global Biogen Clinical Trial Center  ·  clinicaltrials@biogen.com

Always discuss trial participation with your own doctor first.

Locations (1)

Mass General Hospital -MGHBoston, Massachusetts, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07259980