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New pill aims to slow Parkinson's in genetically targeted patients

NCT ID NCT06680830

Disease control Sponsor: Neuron23 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 5 times

Summary

This Phase 2 trial tests an oral drug called NEU-411 in 150 adults aged 40-80 with early Parkinson's disease who have a specific genetic marker (LRRK2-driven). The study is double-blind and placebo-controlled, meaning neither patients nor doctors know who gets the real drug. Researchers will measure changes in symptoms using a smartphone app and standard rating scales, and track side effects over about a year.

What this could mean

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

Active substance
NEU-411 (an oral drug that blocks LRRK2 protein activity)
What this could lead to
If successful, this could point toward a treatment that slows or stops early Parkinson's in people with a specific genetic profile.
What could go wrong
This is a Phase 2 trial with only 150 participants, so results may not apply to all Parkinson's patients. The drug may not work better than placebo, and side effects are still being studied.

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 150 people

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

Started

Jan 2025

Expected to finish

Jun 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

40 to 80 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: 1. Aged 40-80 years at time of screening, inclusive 2. Diagnosis of clinically established or clinically probable Parkinson's Disease (PD) 3. LRRK2-driven PD using the investigational companion diagnostic genetic test (CDx) 4. Modified Hoehn and Yahr (mH\&Y) of 1 to 2.5 Exclusion Criteria: 1. Secondary or atypical parkinsonian syndromes 2. Uncontrolled diabetes mellitus with hemoglobin A1c (HbA1c) \>8% 3. Other significant medical conditions (as determined by medical history, examination, or clinical investigations at screening) Additional inclusion and exclusion criteria for the RCP and OLE are outlined in the full study protocol.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

Parkinson disease young-onset Parkinson disease

As listed by the trial registrant

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

Early Parkinson disease (early PD) Idiopathic Parkinson disease Parkinson Parkinson disease Parkinson disease, idiopathic

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

    72 sites in 6 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Augusta University

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero Di Santa Chiara

    RECRUITING

    Pisa, 56126, Italy

  • Banner Sun Health Research Institute

    RECRUITING

    Sun City, Arizona, 85351, United States

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Central Texas Neurology Consultants

    RECRUITING

    Round Rock, Texas, 78681, United States

  • Centrum Medyczne Neuromed

    RECRUITING

    Bydgoszcz, 85-163, Poland

  • Cleveland Clinic

    RECRUITING

    Las Vegas, Nevada, 89106, United States

  • Clinical Aging Research Unit, Newcastle University

    RECRUITING

    Newcastle upon Tyne, England, NE4 5PL, United Kingdom

  • Columbia University

    RECRUITING

    New York, New York, 10032, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Esperanza Clinical

    RECRUITING

    Murrieta, California, 92562, United States

  • EvergreenHealth

    RECRUITING

    Kirkland, Washington, 98034, United States

  • Fondazione Policilinico Universitario A Gemelli IRCCS

    RECRUITING

    Rome, 00168, Italy

  • Hospital Clinic de Barcelona (Hospital Clinic i Provincial) - Barnaclinic S.A.

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario HM Puerta del Sur

    RECRUITING

    Móstoles, 28938, Spain

  • Hospital Universitario Virgen del Rocio (HUVR) - Instituto de Biomedicina de Sevilla (IBIS)

    RECRUITING

    Seville, 41013, Spain

  • IRCCS Ospedale San Raffaele (HSR) - Dipartimento Di Neurologia

    RECRUITING

    Milan, 20132, Italy

  • Icahn School of Medicine at Mount Sinai/Mount Sinai West

    RECRUITING

    New York, New York, 10019, United States

  • Inland Northwest Research

    RECRUITING

    Spokane, Washington, 99202, United States

  • Instituto de Investigacion Sanitaria Biocruces Bizkaia - Hospital Universitario Cruces

    RECRUITING

    Barakaldo, 49003, Spain

  • Insula Badania Sp. Z o.o.

    RECRUITING

    Warsaw, 02-699, Poland

  • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - San Raffaele Pisana

    RECRUITING

    Rome, 00166, Italy

  • London North West University Healthcare NHS Trust - Northwick Park Hospital

    NOT_YET_RECRUITING

    Harrow, HA1 3UJ, United Kingdom

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • NZOZ Wielospecjalistyczna Poradnia Lekarska Synapsis Lech Szczechowski

    RECRUITING

    Katowice, 32-600, Poland

  • Neuro-Pain Medical Center

    RECRUITING

    Fresno, California, 93710, United States

  • Neurology Consultants of Dallas PA

    RECRUITING

    Dallas, Texas, 75243, United States

  • Neurology One

    RECRUITING

    Orlando, Florida, 32825, United States

  • Ninewells Hospital and Medical School - NHS Tayside

    RECRUITING

    Dundee, Scotland, DD19SY, United Kingdom

  • Northwell Health

    RECRUITING

    Manhasset, New York, 11030, United States

    Contact Email: •••••@•••••

  • Northwestern Medical Group, Department of Neurology

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Ochsner Clinic Foundation

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • Oregon Health & Science University (OHSU)

    RECRUITING

    Portland, Oregon, 97239, United States

  • Panthera Enfield

    NOT_YET_RECRUITING

    London, EN3 4GS, United Kingdom

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

    RECRUITING

    Boca Raton, Florida, 33486, United States

  • Parkinson's Research Centers of America - Palo Alto

    RECRUITING

    Palo Alto, California, 94301, United States

  • Policlinica Gipuzkoa - Centro de Investigacion Parkinson (CIP)

    RECRUITING

    San Sebastián, Donostia, 20014, Spain

  • Pro Life Medica Sp. z o. o. ETA Lublin

    RECRUITING

    Lublin, 20-412, Poland

  • Quest Research Institute

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • Rambam Medical Center

    RECRUITING

    Haifa, 3109601, Israel

  • Shaare Zedek Medical Center

    RECRUITING

    Jerusalem, 9103102, Israel

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, 5262000, Israel

  • St George's Hospital, University of London

    RECRUITING

    London, England, SW17 0QT, United Kingdom

  • Struthers Parkinson Center

    RECRUITING

    Golden Valley, Minnesota, 55427, United States

  • Sutter Neuroscience Institute

    RECRUITING

    Sacramento, California, 95816, United States

  • Tel Aviv Medical Center

    RECRUITING

    Tel Aviv, 6423906, Israel

  • The Movement Disorder Clinic of Oklahoma

    RECRUITING

    Tulsa, Oklahoma, 74136, United States

    Contact Email: •••••@•••••

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • Thomas Jefferson University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • USF Parkinson's & Movement Disorders Clinic

    RECRUITING

    Tampa, Florida, 33613, United States

  • Universidad Autonoma de Madrid (UAM) - Hospital Universitario de La Princesa

    RECRUITING

    Madrid, 28006, Spain

  • Universita Degli Studi Della Campania "Luigi Vanvitelli" - Azienda Ospedaliera Universitaria

    RECRUITING

    Naples, 80138, Italy

  • Universita Degli Studi Di Padova - Azienda Ospedaliera Di Padova - Clinica Neurologica

    RECRUITING

    Padua, 35128, Italy

  • University College London Hospitals NHS Foundation Trust

    RECRUITING

    London, England, WC1N 3BG, United Kingdom

  • University of Arkansas

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • University of California, Irvine

    RECRUITING

    Irvine, California, 92697, United States

  • University of California, Los Angeles

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of Colorado - Anschutz Medical Campus

    RECRUITING

    Aurora, Colorado, 80045, United States

    Contact Email: •••••@•••••

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32608, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Kentucky

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Maryland

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of New Mexico

    RECRUITING

    Albuquerque, New Mexico, 87106, United States

  • University of North Carolina - Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Rochester

    RECRUITING

    Rochester, New York, 14618, United States

  • University of Utah Movement Division

    RECRUITING

    Salt Lake City, Utah, 84108, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Vanderbilt University

    RECRUITING

    Nashville, Tennessee, 37232, United States

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