Biogen: Muscular Atrophy, Spinal trials

The registry lists 27 Muscular Atrophy, Spinal studies with Biogen as lead sponsor. 5 are open to participants now and 8 have results posted.

Phase 1 6Phase 2 4Phase 3 9Phase 4 1No phase 8(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• 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 RisdiplamRecruitingNCT07444476Phase 3
• A Study to Learn About the Safety and Effects of Salanersen (BIIB115) When Given to Babies With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Onasemnogene AbeparvovecRecruitingNCT07444450Phase 3
• A Study to Learn About Salanersen's (BIIB115) Effects on Movement and Its Safety When Given Before Symptoms Appear in Babies With Genetically Diagnosed Spinal Muscular Atrophy (SMA)RecruitingNCT07221669Phase 3
• A Study to Find Out How Nusinersen is Processed in the Body When Given Through the ThecaFlex DRx™ System in Adult and Pediatric Participants With Spinal Muscular Atrophy (PIERRE-PK)RecruitingNCT06555419Phase 1
• A Study to Learn How Nusinersen (Spinraza) Affects Participants With Spinal Muscular Atrophy (SMA) Who Took it Before or During Pregnancy And About The Health of Their BabiesRecruitingNCT05789758
• Study of Nusinersen (BIIB058) in Participants With Spinal Muscular AtrophyCompletedNCT04089566Phase 3Results posted
• A Study for Participants With Spinal Muscular Atrophy (SMA) Who Previously Participated in Nusinersen (ISIS 396443) Investigational StudiesCompletedNCT02594124Phase 3Results posted
• A Study to Assess the Safety and Tolerability of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA).TerminatedNCT02462759Phase 2Results posted
• A Study of Multiple Doses of Nusinersen (ISIS 396443) Delivered to Infants With Genetically Diagnosed and Presymptomatic Spinal Muscular AtrophyCompletedNCT02386553Phase 2Results posted
• A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Participants With Later-onset Spinal Muscular Atrophy (SMA)CompletedNCT02292537Phase 3Results posted
• A Study to Assess the Efficacy and Safety of Nusinersen (ISIS 396443) in Infants With Spinal Muscular AtrophyTerminatedNCT02193074Phase 3Results posted
• A Study to Assess the Efficacy, Safety and Pharmacokinetics of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy (SMA)CompletedNCT01839656Phase 2Results posted
• An Open-label Safety, Tolerability and Dose-Range Finding Study of Multiple Doses of Nusinersen (ISIS 396443) in Participants With Spinal Muscular AtrophyCompletedNCT01703988Phase 1/2Results posted
• Adult Spinal Muscular Atrophy (SMA) China RegistryActive, not recruitingNCT05618379
• A Study to Learn About the Safety of BIIB115 Injections and How BIIB115 is Processed in the Bodies of Healthy Adult Male Volunteers and of Pediatric Participants With Spinal Muscular Atrophy Who Previously Took Onasemnogene AbeparvovecActive, not recruitingNCT05575011Phase 1
• Virtual Reality for the Mitigation of Anxiety During Intrathecal Administration in Participants With Spinal Muscular AtrophyCompletedNCT05354414Not applicable
• A Study to Assess the Clinical Validity of Konectom™ in Adults Living With Neuromuscular DisordersCompletedNCT05109637Not applicable
• A Study to Learn About the Effect of Higher Doses of Nusinersen (BIIB058) Given as Injections to Participants With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Risdiplam (ASCEND)Active, not recruitingNCT05067790Phase 3
• Pediatric Spinal Muscular Atrophy (SMA) China RegistryActive, not recruitingNCT05042921
• A Study to Learn About the Long-Term Safety of Higher Doses of Nusinersen (BIIB058) Given as Injections to Participants With Spinal Muscular Atrophy (SMA) Who Took Part in an Earlier Nusinersen Trial (ONWARD)CompletedNCT04729907Phase 3
• A Study to Learn About the Effect of Nusinersen (BIIB058) Given as Injections to Children With Spinal Muscular Atrophy (SMA) Who Were Previously Treated With Onasemnogene Abeparvovec (RESPOND)CompletedNCT04488133Phase 4
• Non-Interventional, Postmarketing Surveillance Study of Nusinersen Sodium InjectionCompletedNCT04419233
• A Study of the Safety of Nusinersen (Spinraza®) and Its Effects on Motor Function in Koreans Living With SMA Treated During Their Usual Medical CareActive, not recruitingNCT04317794
• Expanded Access Program (EAP) for Nusinersen in Participants With Infantile-onset (Consistent With Type 1) Spinal Muscular Atrophy (SMA)No longer availableNCT02865109
• An Open-label Safety and Tolerability Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA) Who Previously Participated in ISIS 396443-CS2 (NCT01703988) or ISIS 396443-CS10 (NCT01780246)CompletedNCT02052791Phase 1
• An Open-label Safety and Tolerability Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy Who Previously Participated in ISIS 396443-CS1 (NCT01494701)CompletedNCT01780246Phase 1
• An Open-label Safety, Tolerability, and Dose-range Finding Study of Nusinersen (ISIS 396443) in Participants With Spinal Muscular Atrophy (SMA)CompletedNCT01494701Phase 1