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

Study Identifier:
QT-0179
ClinicalTrials.gov Identifier:
NCT05866419
EudraCT Identifier:
N/A
Sponsor:
Alcyone Therapeutics, Inc
Recruiting

Study Details

Medical Condition
  • All Spinal Muscular Atrophies
Study Drug
    Date
    Nov 2023 - May 2026
    Patient Requirements
    Sex: Female & Male
    Age: 3+ years
    Requirements Information

    Protocol 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.

    Trial Locations

    Location
    Status
    Location
    Children's Hospital Orange County
    Orange, California, United States, 92868
    Status
    Recruiting
    Location
    Stanford Medical Center
    Palo Alto, California, United States, 94301
    Status
    Recruiting
    Location
    Rady Children's Hospital
    San Diego, California, United States, 92037
    Status
    Recruiting
    Location
    Boston Children's Hospital
    Boston, Massachusetts, United States, 02115
    Status
    Recruiting
    Location
    Helen DeVos Children's Hospital
    Grand Rapids, Michigan, United States, 49503
    Status
    Recruiting
    Location
    Columbia University Irving Medical Center
    New York, New York, United States, 10032
    Status
    Not yet recruiting

    Contact Cure SMA

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