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NCT04167540 · ClinicalTrials.gov registry record · Phase 1
GDNF Gene Therapy for Parkinson's Disease
A Phase 1 study of Parkinson's Disease, sponsored by Brain Neurotherapy Bio.
- Active
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 3
- Study locations
NCT04167540: Active Phase 1 study of Parkinson's Disease, sponsored by Brain Neurotherapy Bio.
NCT04167540 is a Phase 1 study of Parkinson's Disease that is active but no longer recruiting, run by Brain Neurotherapy Bio. The registered enrollment target is 11 participants, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04167540, a Phase 1 study of Parkinson's Disease, is active but no longer recruiting, sponsored by Brain Neurotherapy Bio.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 3
- Study locations
Study Summary
The objective of this Phase 1b investigation is to evaluate the safety and potential clinical effect of AAV2-GDNF delivered to the putamen in subjects with either a recent or a long-standing diagnosis of PD.
Primary Outcome
Evaluation of the safety and tolerability through the assessment of incidence of TEAE, identified by MedDRA preferred term and grouped by MedDRA System Organ Class, as well as clinically meaningful changes in clinical exams or laboratory assays.
Conditions Studied
Interventions
- BIOLOGICAL AAV2-GDNF
Study Locations (3)
California
- University of California Irvine - Irvine
- University of California San Francisco - San Francisco
Ohio
- The Ohio State University Medical Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2020-04-01 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
What the registry record for NCT04167540 still lists
NCT04167540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 635-participant average among 158 other Parkinson's Disease trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 1 intervention - of which AAV2-GDNF is the first listed.
NCT04167540 reports a single indexed study location in California, Ohio.
Frequently Asked Questions
What is clinical trial NCT04167540 about?
NCT04167540 is a clinical study titled "GDNF Gene Therapy for Parkinson's Disease". The objective of this Phase 1b investigation is to evaluate the safety and potential clinical effect of AAV2-GDNF delivered to the putamen in subjects with either a recent or a long-standing diagnosis of PD.
What is the current status of trial NCT04167540?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2020-04-01. Estimated completion is 2027-06.
What conditions does trial NCT04167540 study?
This clinical trial studies the following conditions: Parkinson's Disease.
What interventions are being tested in trial NCT04167540?
The interventions under investigation include: AAV2-GDNF (BIOLOGICAL).
Who is sponsoring clinical trial NCT04167540?
This trial is sponsored by Brain Neurotherapy Bio, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04167540 being conducted?
This trial has 3 study locations across California, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04167540's enrollment target sits among peer trials
11 145th of 158 higher than 14 of 158 other Parkinson's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson's Disease 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.
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