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Gene therapy trial hopes to ease Parkinson's symptoms

NCT ID NCT06285643

Disease control Sponsor: AskBio Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times

Summary

This Phase 2 study tests whether a single dose of AAV2-GDNF gene therapy, delivered directly into the brain, can improve motor function in adults with moderate Parkinson's disease. About 127 participants will receive either the gene therapy or a sham surgery. The main goal is to see if the treatment increases 'good on time' without troublesome side effects over 18 months.

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 gene therapy
What this could lead to
If successful, this could lead to a new gene therapy that helps control Parkinson's symptoms and reduces the need for daily medications.
What could go wrong
This is an early Phase 2 trial with only 127 participants, so results may not apply to everyone. The sham surgery control group helps test safety, but there are risks from the surgical procedure and the gene therapy itself.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 127 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Aug 2028

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

45 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.

Inclusion Criteria: Age 1. Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent Type of Subject and Disease Characteristics 2. Diagnosed with Parkinson's disease in the past 4-10 years (inclusive) as defined by the following: 1. Presence of bradykinesia PLUS any of the following: * Rigidity * Rest tremor * Postural instability 2. Presence of motor fluctuations as measured by the PD Motor Diary 3. Stable anti-parkinsonian medication regimen for \>/= 4 weeks prior to screening 4. Must demonstrate responsiveness to levodopa therapy Exclusion Criteria: * Known history or current evidence of medical, genetic, or neurological conditions that may provide an alternative to idiopathic PD diagnosis * Presence or history of significant vascular and/or cardiovascular disease * Presence of significant cognitive impairment, poorly controlled depression/anxiety * Presence or history of psychosis or impulse control disorder * History of malignancy other than treated cutaneous squamous or basal cell carcinomas * Presence of clinically relevant conditions that could compromise surgical suitability and/or subject safety * Contraindication to magnetic resonance imaging and/or use gadolinium-based contrast agents * Prior history of brain surgery including, but no limited: DBS, pallidotomy focused ultrasound thalamotomy, or other experimental neurosurgical procedure * Chronic immunosuppressive therapy

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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 disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    35 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CenExel Rocky Mountain Clinical Research (Neurology)

    RECRUITING

    Englewood, Colorado, 80113, United States

  • Charité - Universitätsmedizin Berlin (Surgical)

    ACTIVE_NOT_RECRUITING

    Berlin, Germany

  • Cleveland Clinic Lou Ruvo (Neurology)

    RECRUITING

    Las Vegas, Nevada, 89106, United States

  • Columbia University

    RECRUITING

    New York, New York, 10032, United States

  • Copernicus Podmiot Leczniczy, Szpital św. Wojciecha (Neurology)

    RECRUITING

    Gdansk, Poland

  • Duke Neurosurgery (Surgical)

    ACTIVE_NOT_RECRUITING

    Durham, North Carolina, 27705, United States

  • Duke University (Neurology)

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory University (Surgical)

    ACTIVE_NOT_RECRUITING

    Atlanta, Georgia, 30322, United States

  • EvergreenHealth Research Department (Neurology)

    RECRUITING

    Kirkland, Washington, 98034, United States

  • Georgetown University (Neurology)

    RECRUITING

    Washington D.C., District of Columbia, 20057, United States

  • Houston Methodist (Neurology)

    RECRUITING

    Houston, Texas, 77030, United States

  • Houston Methodist (Surgical)

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77030, United States

  • Loma Linda University (Neurology)

    RECRUITING

    Loma Linda, California, 92354, United States

  • Loma Linda University (Surgical)

    ACTIVE_NOT_RECRUITING

    Loma Linda, California, 92354, United States

  • Massachusetts General Hospital (Neurology)

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Massachusetts General Hospital (Surgical)

    ACTIVE_NOT_RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    NOT_YET_RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mazowiecki Szpital Bródnowski (Neurology)

    RECRUITING

    Warsaw, Poland

  • Mazowiecki Szpital Bródnowski (Surgical)

    ACTIVE_NOT_RECRUITING

    Warsaw, Poland

  • Michigan State University (Neurology)

    RECRUITING

    East Lansing, Michigan, 48824, United States

  • North Bristol NHS Trust - Southmead Hospital (Neurology)

    RECRUITING

    Bristol, United Kingdom

  • Ohio State University (Surgical)

    ACTIVE_NOT_RECRUITING

    Columbus, Ohio, 43210, United States

  • Orlando Health Neuroscience Institute

    RECRUITING

    Orlando, Florida, 32806, United States

  • Parkinson's Disease Treatment Center of Southwest Florida (Neurology)

    RECRUITING

    Port Charlotte, Florida, 33980, United States

  • Parkinson's Disease and Movement Disorders Center of Boca Raton (Neurology)

    RECRUITING

    Boca Raton, Florida, 33486, United States

  • Philipps-Universität Marburg (Neurology)

    RECRUITING

    Marburg, Germany

  • Quest Research Institute (Neurology)

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • Rush University Medical Center (Neurology)

    RECRUITING

    Chicago, Illinois, 60612, United States

  • Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego CMKP (Neurology)

    RECRUITING

    Warsaw, Poland

  • Specjalistyczna Praktyka Lekarska Prof. Grzegorz Opala (Neurology)

    RECRUITING

    Katowice, Poland

  • Texas Movement Disorder Specialists

    NOT_YET_RECRUITING

    Georgetown, Texas, 78628, United States

  • UCI Alpha Clinic (Neurology)

    RECRUITING

    Irvine, California, 92697, United States

    Contact Email: •••••@•••••

  • University Hospital of Wales (Surgical)

    ACTIVE_NOT_RECRUITING

    Cardiff, United Kingdom

  • University of California San Francisco (Neurology)

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Florida

    NOT_YET_RECRUITING

    Gainesville, Florida, 32608, United States

  • University of Kansas Medical Center (Neurology)

    RECRUITING

    Kansas City, Kansas, 66103, United States

  • University of Miami

    NOT_YET_RECRUITING

    Miami, Florida, 33125, United States

  • University of North Carolina (Neurology)

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • University of Pennsylvania (Neurology)

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of San Francisco (Surgical)

    ACTIVE_NOT_RECRUITING

    San Francisco, California, 94143, United States

  • University of Utah

    NOT_YET_RECRUITING

    Salt Lake City, Utah, 84132, United States

  • University of Wisconsin (Neurology)

    RECRUITING

    Madison, Wisconsin, 53705, United States

  • Universitätsklinikum Tübingen (Neurology)

    RECRUITING

    Tübingen, Germany

  • Universitätsklinikum Tübingen (Surgical)

    ACTIVE_NOT_RECRUITING

    Tübingen, Germany

  • Universitätsklinikum Würzburg (Neurology)

    RECRUITING

    Würzburg, Germany

  • Vanderbilt University (Neurology)

    RECRUITING

    Nashville, Tennessee, 37232, United States

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