Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy
Public ClinicalTrials.gov record NCT05866419. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Safety and Performance of the ThecaFlex DRx™ System Port and Catheter for Chronic Intrathecal Access, Cerebrospinal Fluid (CSF) Aspiration, and DElivery of Nusinersen in Spinal Muscular Atrophy (SMA) Patients Resistant to Lumbar PunctuRE Trial (PIERRE)
Study identification
- NCT ID
- NCT05866419
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Lead sponsor
- Alcyone Therapeutics, Inc
- Industry
- Enrollment
- 90 participants
Conditions and interventions
Conditions
Interventions
- ThecaFlex DRx System Device
Device
Eligibility (public fields only)
- Age range
- 3 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 26, 2023
- Primary completion
- Mar 31, 2028
- Completion
- Jun 30, 2030
- Last update posted
- Apr 15, 2026
2023 – 2030
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | Recruiting |
| Children's Hospital Orange County | Orange | California | 92868 | Recruiting |
| Stanford Medical Center | Palo Alto | California | 94301 | Recruiting |
| Rady Children's Hospital | San Diego | California | 92037 | Recruiting |
| Nemours Children's Hospital, Florida | Orlando | Florida | 32827 | Recruiting |
| Lurie Childrens Hospital | Chicago | Illinois | 60611 | Recruiting |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | Recruiting |
| Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | Recruiting |
| Columbia University Irving Medical Center/NewYork Presbyterian Hospital | New York | New York | 10032 | Recruiting |
| UH Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | Recruiting |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | Recruiting |
| Children's Hospital Philadelphia | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Texas Children's Hospital | Houston | Texas | 77030 | Recruiting |
| University of Virginia | Charlottesville | Virginia | 22903 | Recruiting |
| Childrens Hospital of the King's Daughters | Norfolk | Virginia | 23510 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05866419, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 15, 2026 · Synced May 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05866419 live on ClinicalTrials.gov.