A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety in Participants Aged 15 to 60 Years With Spinal Muscular Atrophy (SMA) Who Are Either New to SMA Treatment or Were Previously Treated With Risdiplam

Recruiting Phase 3 Interventional Study
Spinal Muscular Atrophy
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
15 – 60
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
90 (estimated)
Sponsor
Biogen · Industry
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About This Trial
In this study, researchers will learn more about the effects and safety of BIIB115, also known as salanersen. Specifically, researchers will learn more about how salanersen works in individuals with SMA who are between the ages of 15 and 60 years old. In most people living with SMA, changes to or a lack of a gene called survival motor neuron 1 (SMN1) - often referred to as gene mutations or varia…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria: * Participants aged 15 to 60 years, inclusive, at the time of informed consent * Participants with genetic documentation of 5q Spinal Muscular Atrophy (SMA) (homozygous gene deletion or mutation or compound heterozygous mutation). * Participants with clinical signs and sympt…
Contacts

US Biogen Clinical Trial Center

866-633-4636

clinicaltrials@biogen.com

CONTACT

Global Biogen Clinical Trial Center

clinicaltrials@biogen.com

CONTACT