Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3+
SponsorAlcyone Therapeutics, Inc
About this trial
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.
Eligibility criteria
Qualifiers
Subject is 3 years or older
Subject diagnosed with SMA who are candidates for Spinraza treatment as indicated in its label
Subject with respiratory issues or other comorbidities who is at an increased risk for complications due to the need for repeat anesthesia and imaging radiation exposure to safely perform LP; or
Subjects for whom the treating physician determines implantation of the ThecaFlex DRx™ System is otherwise in the subject's best interest
Disqualifiers
Subject meets any of the contraindications for use of the ThecaFlex DRx™ System as outlined in the ThecaFlex DRx™ System Instructions for Use
Presence or history of (< 6 months prior to the procedure): an implanted microinfusion pump, intrathecal catheter, or other intrathecal drug delivery devices/component, or implanted shunt for drainage of cerebrospinal fluid (CSF), or reservoir in the CSF space (note: any ThecaFlex Port and Catheter System must not be placed in the same location as a previous indwelling port and catheter)
Subject is pregnant or nursing or plans to become pregnant during the course of the clinical investigation
Severe structural impediment that may preclude safe implantation of the catheter and port
Trial design
Treatments tested in this trial
- ThecaFlex DRx System
Treatment groups
90 Participants
are divided into 1 treatment groupSponsors and collaborators
Alcyone Therapeutics, Inc
Lead sponsor
Biogen
Collaborator
Source ClinicalTrials.gov