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ACTIVE NOT RECRUITING Phase 1

GDNF Gene Therapy for Parkinson's Disease

NCT04167540 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 11 participants
Start Date 2020-04-01
Est. Completion 2027-06
Phase Phase 1

Sponsor

Brain Neurotherapy Bio

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04167540

The ClinicalTrials.gov registry entry for NCT04167540 describes a study currently listed as active not recruiting. It is categorized as Phase 1, 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 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brain Neurotherapy Bio, 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 1 condition, with Parkinson's Disease appearing as the primary indexed condition, and to 1 intervention — of which AAV2-GDNF 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: NCT04167540 reports 3 study locations spanning 2 distinct geographic areas — top geographies include California, Ohio. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04167540?

The interventions under investigation include: AAV2-GDNF (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04167540?

This trial is sponsored by Brain Neurotherapy Bio, 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 NCT04167540 being conducted?

This trial has 3 study locations across California, Ohio. 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