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This study looks at the long-term safety of the drug Tofersen (Qalsody) in Chinese participants with SOD1-associated amyotrophic lateral sclerosis (ALS). Adults aged 18 and older with a diagnosis of SOD1-ALS may take part. The study is in Phase 4 and is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Key Inclusion Criteria: * Age ≥ 18 years at the time of informed consent. * Must have diagnosis of SOD1-ALS. * If taking riluzole, participant must be on a stable dose for ≥ 30 days prior to Day 1 and expected to remain at that dose until the final study visit. * If taking edaravone, participant must have initiated edaravone ≥ 60 days (2 treatment cycles) prior to Day 1 and expected to remain at that dose until the final study visit, unless the Investigator determines that edaravone should be discontinued for medical reasons, in which case it may not be restarted during the study. * All women of childbearing potential must practice effective contraception during the study. Key Exclusion Criteria: * Hypersensitivity to the active substance or any of the excipients of tofersen injection. * Current or past administration of tofersen injection, in either a commercial or a clinical study setting. * Prior or current treatment with small interfering ribonucleic acid (RNA), stem cell therapy, or gene therapy. * Treatment with another investigational drug, biological agent, or device within 1 month or 5 half-lives of study agent, whichever is longer, prior the Baseline Visit. * Participants who are pregnant or currently breastfeeding, and those intending to become pregnant during the study. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.