- Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy — Recruiting • Non-phase study • Gastroenterology • NCT05866419.
- Implanted spinal port safely delivers nusinersen treatment to spinal muscular atrophy patients over 12 months.
Verify eligibility, endpoints and current status on the original ClinicalTrials.gov registry before acting on this summary.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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. Conditions: Spinal Muscular Atrophy, Spine Deformity, Scoliosis Interventions: ThecaFlex DRx System Lead Sponsor: Alcyone Therapeutics, Inc Planned Enrollment: 90 participants