Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING NA

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

NCT05866419 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 90 participants
Start Date 2023-11-27
Est. Completion 2027-03
Phase NA

Sponsor

Alcyone Therapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05866419

The ClinicalTrials.gov registry entry for NCT05866419 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 90 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alcyone Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05866419 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, California, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05866419?

The interventions under investigation include: ThecaFlex DRx System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05866419?

This trial is sponsored by Alcyone Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial