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Clinical Trial

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

NCT: NCT05866419 · RECRUITING

NCT IDNCT05866419
StatusRECRUITING
Start Date2023-11-27
SponsorAlcyone Therapeutics, Inc (INDUSTRY)
First posted
Last updated

Brief Summary

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.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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