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NCT04680065 · ClinicalTrials.gov registry record · Phase 1
GDNF Gene Therapy for Multiple System Atrophy
A Phase 1 study of Multiple System Atrophy, sponsored by Brain Neurotherapy Bio.
- Active
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
- 7
- Study locations
NCT04680065 is a Phase 1 study of Multiple System Atrophy that is active but no longer recruiting, run by Brain Neurotherapy Bio. The registered enrollment target is 9 participants, below the 268-participant average among 30 other Multiple System Atrophy trials with a reported enrollment target (97% lower). The trial reports 7 study locations across 7 states.
The verdict
NCT04680065, a Phase 1 study of Multiple System Atrophy, is active but no longer recruiting, sponsored by Brain Neurotherapy Bio.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
- 7
- Study locations
Study Summary
The objective of this randomized, double-blinded, placebo-controlled Phase 1 investigation is to evaluate the safety and potential clinical effect of AAV2-GDNF delivered to the putamen in subjects with either a possible or probable diagnosis of Multiple System Atrophy.
Conditions Studied
Interventions
- BIOLOGICAL AAV2-GDNF gene therapy
- PROCEDURE Sham (Placebo) Surgery
Study Locations (7)
California
- University of California Irvine - Irvine
Florida
- Parkinson's Disease and Movement Disorders Center of Boca Raton - Boca Raton
Massachusetts
- Massachusetts General Hospital - Boston
Michigan
- Quest Research Institute - Farmington Hills
New York
- NYU Langone Health - New York
Ohio
- The Ohio State University Medical Center - Columbus
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2023-10-03 |
| Est. Completion | 2028-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04680065
The ClinicalTrials.gov registry entry for NCT04680065 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 268-participant average among 30 other Multiple System Atrophy trials with a reported enrollment target (97% lower). The listed sponsor is Brain Neurotherapy Bio, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Multiple System Atrophy appearing as the primary indexed condition, and to 2 interventions - of which AAV2-GDNF gene therapy is the first listed.
NCT04680065 reports 7 study locations spanning 7 distinct geographic areas - top geographies include California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04680065 about?
NCT04680065 is a clinical study titled "GDNF Gene Therapy for Multiple System Atrophy". The objective of this randomized, double-blinded, placebo-controlled Phase 1 investigation is to evaluate the safety and potential clinical effect of AAV2-GDNF delivered to the putamen in subjects with either a possible or probable diagnosis of Multiple System Atrophy.
What is the current status of trial NCT04680065?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2023-10-03. Estimated completion is 2028-08.
What conditions does trial NCT04680065 study?
This clinical trial studies the following conditions: Multiple System Atrophy.
What interventions are being tested in trial NCT04680065?
The interventions under investigation include: AAV2-GDNF gene therapy (BIOLOGICAL), Sham (Placebo) Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT04680065?
This trial is sponsored by Brain Neurotherapy Bio, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04680065 being conducted?
This trial has 7 study locations across California, Florida, Massachusetts, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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