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Could this pill slow Parkinson's? new study tests UCB0599

NCT ID NCT04658186

Disease control Sponsor: UCB Biopharma SRL 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026

Summary

This study tested an experimental oral drug, UCB0599, in 496 people with early-stage Parkinson's disease. The goal was to see if the drug could safely slow down the worsening of symptoms over 18 months compared to a placebo. Participants were randomly assigned to receive either the drug or a dummy pill, and their symptoms were tracked using standard Parkinson's rating scales.

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

496 people

The number who actually took part.

Started

Dec 2020

Finished

Sep 2024

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 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: * Study participant must be 40 to 75 years of age inclusive, at the time of signing the informed consent * Study participant has Parkinson's Disease (PD), with a diagnosis made by a neurologist according to the 2015 Movement Disorder Society criteria within 2 years of Baseline Visit (including diagnosis during Screening) * The following diagnostic criteria must be met: bradykinesia AND at least ONE of the following: muscular rigidity, or resting tremor * A Screening Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT), or a historical DaT-SPECT within 3 months of the Screening Visit that has been qualified by the central reader, shows evidence of dopamine transporter deficit per study requirements and as determined by a central reader * Study participant is in the ≤2.5 modified Hoehn and Yahr stage at Screening * Study participant has never taken medications for the treatment of motor symptoms of PD and is not expected to require starting symptomatic treatment (ST) with a high likelihood in the next 6 months as far as clinical judgement allows * Study participant has never taken part in disease-modifying treatment studies directed at neurodegenerative disease (NDD) * Study participant does not take N-acetyl cysteine or other cysteine donors or glutathione precursors on a regular basis as a food supplement * Study participant is willing, competent, and able to comply with all aspects of the protocol, including follow-up schedule and biospecimen collection * Study participant has a body mass index (BMI) of 16 to 34kg/m² (inclusive) * Contraception i) A male participant must agree to use contraception during the Treatment Period and for at least 90 days after the last dose ofstudy medication and refrain from donating sperm during this period ii) A female participant is eligible to participate if she is not pregnant, not breastfeeding, andat least one of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 1 month after the last dose of study medication. The study participant must have a negative serum pregnancy test at Screening, which is to be confirmed negative by urine testing prior to the first dose of study medication at Baseline (Visit 3). If oral contraception is used, an additional barrier method will be required during the study as a study medication related-gastrointestinal upset or a drug interaction by CYP3A4 induction could interfere with efficacy Exclusion Criteria: * Study participant has a known hypersensitivity to any components (and/or its excipients) of the study medication or comparative drugs as stated in the protocol * Study participant has a brain magnetic resonance imaging (MRI) scan performed during Screening indicative of a clinically significant abnormality or a historical MRI scan during the 6 months before Screening Visit 1 of sufficient quality to show such abnormalities. In case of doubt, the significance is determined on a case-by-case basis in close collaboration with the Medical Monitor and should not include abnormalities like age-appropriate brain atrophy, minor white matter signals, or mild vasculopathy * Study participant has any contraindication for the brain MRI or Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT) imaging * Study participant has a Montreal Cognitive Assessment (MoCA) score less than 23, indicating mild cognitive impairment or other significant cognitive impairment or clinical dementia at Screening that, in the opinion of the Investigator, would interfere with study evaluation * Study participant has abnormalities in lumbar spine previously known or determined by a Screening lumbar x-ray (if conducted) that could preclude lumbar puncture, in the opinion of the Investigator. The participant must be excluded from lumbar puncture but not from study participation * Study participant has clinically significant electrocardiogram (ECG) abnormality at Screening, in the opinion of the Investigator * Study participant has past history of use of medications for the treatment of motor symptoms of PD. Short (up to 4 weeks) past use of medications for the treatment of motor symptoms is permitted following a sufficient washout period. Medications included are: levodopa (maximum 400mg per day), dopamine agonists, monoamine oxidase B (MAO-B) inhibitors, anticholinergics, or amantadine. A sufficient washout period is at least 3 months prior to the Baseline Visit

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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.

Early stage Parkinson's disease

Contacts and locations

Locations

  • Pd0053 40023

    Erlangen, Germany

  • Pd0053 40024

    Hanover, Germany

  • Pd0053 40045

    A Coruña, Spain

  • Pd0053 40046

    Córdoba, Spain

  • Pd0053 40049

    Seville, Spain

  • Pd0053 40130

    Marseille, France

  • Pd0053 40131

    Strasbourg, France

  • Pd0053 40138

    Bonn, Germany

  • Pd0053 40159

    Barcelona, Spain

  • Pd0053 40174

    Mainz, Germany

  • Pd0053 40175

    London, United Kingdom

  • Pd0053 40197

    Amiens, France

  • Pd0053 40249

    Kiel, Germany

  • Pd0053 40257

    Roma, Italy

  • Pd0053 40267

    Barcelona, Spain

  • Pd0053 40306

    Newcastle upon Tyne, United Kingdom

  • Pd0053 40352

    Pamplona, Spain

  • Pd0053 40359

    Nijmegen, Netherlands

  • Pd0053 40424

    Créteil, France

  • Pd0053 40457

    Plymouth, United Kingdom

  • Pd0053 40515

    Berlin, Germany

  • Pd0053 40524

    Nîmes, France

  • Pd0053 40525

    Paris, France

  • Pd0053 40526

    Lille, France

  • Pd0053 40527

    Bordeaux, France

  • Pd0053 40528

    Toulouse, France

  • Pd0053 40529

    Marburg, Germany

  • Pd0053 40530

    Dresden, Germany

  • Pd0053 40531

    Regensburg, Germany

  • Pd0053 40532

    Haag in Oberbayern, Germany

  • Pd0053 40533

    Padova, Italy

  • Pd0053 40534

    Roma, Italy

  • Pd0053 40535

    Oświęcim, Poland

  • Pd0053 40536

    Warsaw, Poland

  • Pd0053 40538

    Krakow, Poland

  • Pd0053 40539

    Katowice, Poland

  • Pd0053 40540

    Madrid, Spain

  • Pd0053 40541

    San Sebastián, Spain

  • Pd0053 40542

    Móstoles, Spain

  • Pd0053 40543

    London, United Kingdom

  • Pd0053 40544

    Motherwell, United Kingdom

  • Pd0053 40555

    Brescia, Italy

  • Pd0053 40635

    Nantes, France

  • Pd0053 40694

    Bydgoszcz, Poland

  • Pd0053 40696

    Krakow, Poland

  • Pd0053 40697

    Roma, Italy

  • Pd0053 40698

    London, United Kingdom

  • Pd0053 40699

    Warsaw, Poland

  • Pd0053 40700

    Lodz, Poland

  • Pd0053 40702

    Lublin, Poland

  • Pd0053 40705

    Warsaw, Poland

  • Pd0053 40710

    Essen, Germany

  • Pd0053 40711

    Erbach im Odenwald, Germany

  • Pd0053 40719

    Jelenia Góra, Poland

  • Pd0053 50074

    Kansas City, Kansas, 66160, United States

  • Pd0053 50077

    New York, New York, 10021, United States

  • Pd0053 50081

    Phoenix, Arizona, 85013, United States

  • Pd0053 50084

    Charleston, South Carolina, 29425, United States

  • Pd0053 50107

    Burlington, Vermont, 05401-1473, United States

  • Pd0053 50113

    Houston, Texas, 77030, United States

  • Pd0053 50118

    Los Angeles, California, 90033-5315, United States

  • Pd0053 50119

    New York, New York, 10032, United States

  • Pd0053 50121

    Lexington, Kentucky, 40536-0284, United States

  • Pd0053 50140

    Birmingham, Alabama, 35233, United States

  • Pd0053 50199

    Miami, Florida, 33136, United States

  • Pd0053 50243

    Boston, Massachusetts, 02114, United States

  • Pd0053 50255

    Columbus, Ohio, 43210, United States

  • Pd0053 50292

    Kirkland, Washington, 98034-3030, United States

  • Pd0053 50299

    New Brunswick, New Jersey, 08903, United States

  • Pd0053 50310

    Chicago, Illinois, 60612-3863, United States

  • Pd0053 50311

    Cleveland, Ohio, 44195, United States

  • Pd0053 50372

    Cleveland, Ohio, 44106, United States

  • Pd0053 50374

    Calgary, Canada

  • Pd0053 50385

    Fresno, California, 93710, United States

  • Pd0053 50386

    Farmington Hills, Michigan, 48334, United States

  • Pd0053 50387

    Ottawa, Canada

  • Pd0053 50389

    Toronto, Canada

  • Pd0053 50390

    Kelowna, Canada

  • Pd0053 50391

    Tucson, Arizona, 85710, United States

  • Pd0053 50392

    Danbury, Connecticut, 06810, United States

  • Pd0053 50394

    Tampa, Florida, 33613, United States

  • Pd0053 50395

    New Orleans, Louisiana, 70121, United States

  • Pd0053 50396

    Boca Raton, Florida, 33486, United States

  • Pd0053 50397

    Las Vegas, Nevada, 89104, United States

  • Pd0053 50398

    Tulsa, Oklahoma, 74136, United States

  • Pd0053 50399

    Winfield, Illinois, 60190, United States

  • Pd0053 50400

    San Antonio, Texas, 78229, United States

  • Pd0053 50401

    Chicago, Illinois, 60611, United States

  • Pd0053 50402

    Crab Orchard, West Virginia, 25827, United States

  • Pd0053 50410

    Fairfax, Virginia, 22031, United States

  • Pd0053 50416

    La Jolla, California, 92037, United States

  • Pd0053 50419

    Spokane, Washington, 99202, United States

  • Pd0053 50506

    Phoenix, Arizona, 85004-1150, United States

  • Pd0053 50510

    Portland, Oregon, 97239, United States

  • Pd0053 50519

    Fountain Valley, California, 92708, United States

  • Pd0053 50521

    New York, New York, 10029, United States

  • Pd0053 50524

    Bradenton, Florida, 34205, United States

  • Pd0053 50525

    Houston, Texas, 77030-5301, United States

  • Pd0053 50526

    Philadelphia, Pennsylvania, 19107, United States

  • Pd0053 50527

    Toledo, Ohio, 43606, United States

  • Pd0053 50529

    Baltimore, Maryland, 21201-1606, United States

  • Pd0053 50530

    Stony Brook, New York, 11794, United States

  • Pd0053 50531

    Englewood, Colorado, 80113, United States

  • Pd0053 50532

    Knoxville, Tennessee, 37920, United States

  • Pd0053 50534

    Virginia Beach, Virginia, 23456, United States

  • Pd0053 50535

    Williamsville, New York, 14221, United States

  • Pd0053 50536

    Saint Paul, Minnesota, 55130, United States

  • Pd0053 50538

    Farmington, Connecticut, 06030, United States

  • Pd0053 50539

    Little Rock, Arkansas, 72205, United States

  • Pd0053 50542

    Charlottesville, Virginia, 22908, United States

  • Pd0053 50543

    Memphis, Tennessee, 38157, United States

  • Pd0053 50544

    Augusta, Georgia, 30912-0004, United States

  • Pd0053 50546

    Worcester, Massachusetts, 01655, United States

  • Pd0053 50547

    Baltimore, Maryland, 21287, United States

  • Pd0053 50549

    Iowa City, Iowa, 52242, United States

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