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NCT05866419 · ClinicalTrials.gov registry record · NA
Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy
A NA study of Spinal Muscular Atrophy and Scoliosis, sponsored by Alcyone Therapeutics.
- Recruiting
- Registry status
- NA
- Development phase
- 90
- Enrollment target
- 20
- Study locations
NCT05866419: Recruiting NA study of Spinal Muscular Atrophy and Scoliosis, sponsored by Alcyone Therapeutics.
NCT05866419 is a NA study of Spinal Muscular Atrophy and Scoliosis that is actively recruiting participants, run by Alcyone Therapeutics. The registered enrollment target is 90 participants, below the 105-participant average among 22 other Spinal Muscular Atrophy trials with a reported enrollment target (14% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05866419, a NA study of Spinal Muscular Atrophy and Scoliosis, is actively recruiting participants, sponsored by Alcyone Therapeutics.
- RECRUITING
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The primary outcome measures the proportion of subjects with successful implantation of the ThecaFlex DRx™ Port and Catheter System who are able to receive successful intrathecal therapy infusion(s).
Conditions Studied
Interventions
- DEVICE ThecaFlex DRx System
Study Locations (20)
Other
- Universitätsklinikum Essen - Essen
- Centro Clinico Nemo - Milan
- Specialised Hospital Ludwika Rydygiera - Krakow
- Research Institute of Polish Mother's Memorial Hospital - Lodz
- Hospital Universitario La Paz - Madrid
- Hospital Universitario y Politecnico la Fe de Valencia - Valencia
California
- Children's Hospital Orange County - Orange
- Stanford Medical Center - Palo Alto
- Rady Children's Hospital - San Diego
Pennsylvania
- Penn State Milton S. Hershey Medical Center - Hershey
- Children's Hospital Philadelphia - Philadelphia
Virginia
- University of Virginia - Charlottesville
- Childrens Hospital of the King's Daughters - Norfolk
Arizona
- Barrow Neurological Institute - Phoenix
Illinois
- Lurie Childrens Hospital - Chicago
Massachusetts
- Boston Children's Hospital - Boston
Michigan
- Helen DeVos Children's Hospital - Grand Rapids
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2023-11-27 |
| Est. Completion | 2027-03 |
| Phase | NA |
What NCT05866419 shows while recruiting
NCT05866419 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 105-participant average among 22 other Spinal Muscular Atrophy trials with a reported enrollment target (14% lower).
The record links to 3 conditions, with Spinal Muscular Atrophy appearing as the primary indexed condition, and to 1 intervention - of which ThecaFlex DRx System is the first listed.
NCT05866419 names 20 study sites across 11 states, led by Other, California, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05866419 about?
NCT05866419 is a clinical study titled "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) a...
What is the current status of trial NCT05866419?
This trial is currently recruiting. It is a NA study. The enrollment target is 90 participants. The study started on 2023-11-27. Estimated completion is 2027-03.
What conditions does trial NCT05866419 study?
This clinical trial studies the following conditions: Spinal Muscular Atrophy, Scoliosis, Spine Deformity.
What interventions are being tested in trial NCT05866419?
The interventions under investigation include: ThecaFlex DRx System (DEVICE).
Who is sponsoring clinical trial NCT05866419?
This trial is sponsored by Alcyone Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05866419 being conducted?
This trial has 20 study locations across Arizona, California, Illinois, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Spinal Muscular Atrophy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05866419's enrollment target sits among peer trials
90 10th of 22 higher than 13 of 22 other Spinal Muscular Atrophy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spinal Muscular Atrophy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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