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Gene therapy trial hopes to ease Parkinson's symptoms

NCT ID NCT04167540

Disease control Sponsor: Brain Neurotherapy Bio, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage trial tests a single dose of a gene therapy called AAV2-GDNF, delivered directly into the brain, for people with Parkinson's disease. The main goal is to check safety in 11 adults aged 35-75. Researchers will also look at whether it improves motor symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AAV2-GDNF (a gene therapy that delivers GDNF protein to brain cells)
What this could lead to
If safe and effective, this could point toward a new way to slow or improve motor symptoms in Parkinson's disease.
What could go wrong
This is a very early Phase 1 trial with only 11 people, focused on safety. It may not show clear benefit, and brain infusion carries risks like bleeding or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

11 people

The number who actually took part.

Started

Apr 2020

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Male and female adults 35-75 years of age (inclusive) * Diagnosed with Parkinson's disease * Modified Hoehn and Yahr stage I-III OFF medication * Time since receiving a clinical diagnosis of PD and disease severity consistent with one of the following: 1. EITHER: Less than 5 years since clinical diagnosis of PD and mild to moderate UPDRS III OFF score 2. OR: At least 4 years since clinical diagnosis of PD and moderate to severe UPDRS III OFF score * Responsiveness to levodopa Key Exclusion Criteria: * Atypical parkinsonism * Severe dyskinesia * Presence of dementia, psychosis, substance abuse or qualify as "severe depression" * Prior brain surgery (i.e. deep brain stimulator or DBS implantation) or other brain imaging abnormalities * Receiving an investigational drug * History of cancer or poorly controlled medical conditions that would increase surgical risk * Inability to tolerate laying flat in an MRI or allergy to gadolinium

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson's disease

Contacts and locations

Locations

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210, United States

  • University of California Irvine

    Irvine, California, 92697, United States

  • University of California San Francisco

    San Francisco, California, 94103, United States

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