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NCT06683365 · ClinicalTrials.gov registry record · Phase 1
Autologous suraL nervE Grafting to the Substantia nigrA in Patients With Synuclienopathies
A Phase 1 study of Parkinson's Disease and Multiple System Atrophy, sponsored by Craig van Horne, MD, PhD.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT06683365 is a Phase 1 study of Parkinson's Disease and Multiple System Atrophy that is actively recruiting participants, run by Craig van Horne, MD, PhD. The registered enrollment target is 7 participants, below the 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06683365, a Phase 1 study of Parkinson's Disease and Multiple System Atrophy, is actively recruiting participants, sponsored by Craig van Horne, MD, PhD.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I double-blind study focuses on the safety and feasibility of implanting autologous peripheral nerve tissue (PNT) into the substantia nigra area of the brain in persons who have been diagnosed with either Parkinson's disease (PD) or Multiple System Atrophy (MSA). 7 participants will be enrolled, with 4 participants receiving the graft and 3 receiving a sham surgery. Eligible participants will be early in their diagnosis with a lower burden of symptoms. Participants will be followed initially for one year after surgery.
Conditions Studied
Interventions
- PROCEDURE Sural Nerve Graft to the Substantia Nigra
- PROCEDURE Sham surgery
Study Locations (1)
Kentucky
- University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2025-02-25 |
| Est. Completion | 2030-12-02 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06683365
The ClinicalTrials.gov registry entry for NCT06683365 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 642-participant average among 156 other Parkinson's Disease trials with a reported enrollment target (99% lower). The listed sponsor is Craig van Horne, MD, PhD, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Parkinson's Disease appearing as the primary indexed condition, and to 2 interventions - of which Sural Nerve Graft to the Substantia Nigra is the first listed.
NCT06683365 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.
Frequently Asked Questions
What is clinical trial NCT06683365 about?
NCT06683365 is a clinical study titled "Autologous suraL nervE Grafting to the Substantia nigrA in Patients With Synuclienopathies". This phase I double-blind study focuses on the safety and feasibility of implanting autologous peripheral nerve tissue (PNT) into the substantia nigra area of the brain in persons who have been diagnosed with either Parkinson's disease (PD) or Multiple System Atrophy (MSA). 7 participants will be en...
What is the current status of trial NCT06683365?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2025-02-25. Estimated completion is 2030-12-02.
What conditions does trial NCT06683365 study?
This clinical trial studies the following conditions: Parkinson's Disease, Multiple System Atrophy.
What interventions are being tested in trial NCT06683365?
The interventions under investigation include: Sural Nerve Graft to the Substantia Nigra (PROCEDURE), Sham surgery (PROCEDURE).
Who is sponsoring clinical trial NCT06683365?
This trial is sponsored by Craig van Horne, MD, PhD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06683365 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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