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Study identifier: NCT05866419 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy

Condition: Spinal Muscular Atrophy · Spine Deformity · Scoliosis  ·  Sponsor: Alcyone Therapeutics, Inc

PhaseNA
Planned participants90
Who can joinAll sexes, 3 Years to no upper limit
Healthy volunteersNo

About this study

The primary objective of the clinical investigation is to demonstrate successful clinical use of the ThecaFlex DRx™ System in delivering nusinersen in subjects with spinal muscular atrophy (SMA). All enrolled subjects will undergo implantation of the investigational device (ThecaFlex DRx™ System) and will be followed for 12 months after receiving the implant. The 12-month data will be used to assess the primary endpoint support a Pre-Market Approval (PMA) application.

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

Talk to the study team

Janelle Arrambide  ·  857-500-7526  ·  janelle.arrambide@biogen.com

Always discuss trial participation with your own doctor first.

Locations (21)

Barrow Neurological InstitutePhoenix, Arizona, United StatesRecruiting
Children's Hospital Orange CountyOrange, California, United StatesRecruiting
Stanford Medical CenterPalo Alto, California, United StatesRecruiting
Rady Children's HospitalSan Diego, California, United StatesRecruiting
Nemours Children's Hospital, FloridaOrlando, Florida, United StatesRecruiting
Lurie Childrens HospitalChicago, Illinois, United StatesRecruiting
Boston Children's HospitalBoston, Massachusetts, United StatesRecruiting
Helen DeVos Children's HospitalGrand Rapids, Michigan, United StatesRecruiting
Columbia University Irving Medical Center/NewYork Presbyterian HospitalNew York, New York, United StatesRecruiting
UH Rainbow Babies and Children's HospitalCleveland, Ohio, United StatesRecruiting
Penn State Milton S. Hershey Medical CenterHershey, Pennsylvania, United StatesRecruiting
Children's Hospital PhiladelphiaPhiladelphia, Pennsylvania, United StatesRecruiting

+ 9 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT05866419