Status: Recruiting
Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy
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.
Participants needed: 90
Trial details
Age: 3+Biological sex: AllType: InterventionalSponsor: Alcyone Therapeutics, IncUpdated: Apr 16, 2026Locations: 21
Eligibility criteria
Subject is 3 years or older [+7]
Subject meets any of the contraindications for use of the ThecaFlex DRx™ System... [+19]