Condition: Spinal Muscular Atrophy · Spine Deformity · Scoliosis · Sponsor: Alcyone Therapeutics, Inc
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.
Janelle Arrambide · 857-500-7526 · janelle.arrambide@biogen.com
Always discuss trial participation with your own doctor first.
| Barrow Neurological Institute | Phoenix, Arizona, United States | Recruiting |
| Children's Hospital Orange County | Orange, California, United States | Recruiting |
| Stanford Medical Center | Palo Alto, California, United States | Recruiting |
| Rady Children's Hospital | San Diego, California, United States | Recruiting |
| Nemours Children's Hospital, Florida | Orlando, Florida, United States | Recruiting |
| Lurie Childrens Hospital | Chicago, Illinois, United States | Recruiting |
| Boston Children's Hospital | Boston, Massachusetts, United States | Recruiting |
| Helen DeVos Children's Hospital | Grand Rapids, Michigan, United States | Recruiting |
| Columbia University Irving Medical Center/NewYork Presbyterian Hospital | New York, New York, United States | Recruiting |
| UH Rainbow Babies and Children's Hospital | Cleveland, Ohio, United States | Recruiting |
| Penn State Milton S. Hershey Medical Center | Hershey, Pennsylvania, United States | Recruiting |
| Children's Hospital Philadelphia | Philadelphia, Pennsylvania, United States | Recruiting |
+ 9 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05866419