A 18-month Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early-stage Parkinson's Disease
NCT ID: NCT04658186
Last Updated: 2025-10-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
496 participants
INTERVENTIONAL
2020-12-30
2024-09-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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UCB0599 High Dose Arm
Participants will be randomized to receive a predefined high dosage of UCB0599 during the Treatment Period.
UCB0599
Drug: UCB0599 Pharmaceutical form: Granules in capsules Route of administration: Oral use Participants will receive UCB0599 in a pre-specified sequence during the Treatment Period.
Placebo Arm
Participants will be randomized to receive a predefined dosage of Placebo during the Treatment Period.
Placebo
Drug: Placebo Pharmaceutical form: Capsules Route of administration: Oral use Participants will receive Placebo in a pre-specified sequence during the Treatment Period.
UCB0599 Low Dose Arm
Participants will be randomized to receive a predefined low dosage of UCB0599 during the Treatment Period.
UCB0599
Drug: UCB0599 Pharmaceutical form: Granules in capsules Route of administration: Oral use Participants will receive UCB0599 in a pre-specified sequence during the Treatment Period.
Interventions
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UCB0599
Drug: UCB0599 Pharmaceutical form: Granules in capsules Route of administration: Oral use Participants will receive UCB0599 in a pre-specified sequence during the Treatment Period.
Placebo
Drug: Placebo Pharmaceutical form: Capsules Route of administration: Oral use Participants will receive Placebo in a pre-specified sequence during the Treatment Period.
Eligibility Criteria
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Inclusion Criteria
* 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 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
40 Years
75 Years
ALL
No
Sponsors
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The Parkinson Study Group
NETWORK
UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273
Locations
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Pd0053 50140
Birmingham, Alabama, United States
Pd0053 50506
Phoenix, Arizona, United States
Pd0053 50081
Phoenix, Arizona, United States
Pd0053 50391
Tucson, Arizona, United States
Pd0053 50539
Little Rock, Arkansas, United States
Pd0053 50519
Fountain Valley, California, United States
Pd0053 50385
Fresno, California, United States
Pd0053 50416
La Jolla, California, United States
Pd0053 50118
Los Angeles, California, United States
Pd0053 50531
Englewood, Colorado, United States
Pd0053 50392
Danbury, Connecticut, United States
Pd0053 50538
Farmington, Connecticut, United States
Pd0053 50396
Boca Raton, Florida, United States
Pd0053 50524
Bradenton, Florida, United States
Pd0053 50199
Miami, Florida, United States
Pd0053 50394
Tampa, Florida, United States
Pd0053 50544
Augusta, Georgia, United States
Pd0053 50401
Chicago, Illinois, United States
Pd0053 50310
Chicago, Illinois, United States
Pd0053 50399
Winfield, Illinois, United States
Pd0053 50549
Iowa City, Iowa, United States
Pd0053 50074
Kansas City, Kansas, United States
Pd0053 50121
Lexington, Kentucky, United States
Pd0053 50395
New Orleans, Louisiana, United States
Pd0053 50529
Baltimore, Maryland, United States
Pd0053 50547
Baltimore, Maryland, United States
Pd0053 50243
Boston, Massachusetts, United States
Pd0053 50546
Worcester, Massachusetts, United States
Pd0053 50386
Farmington Hills, Michigan, United States
Pd0053 50536
Saint Paul, Minnesota, United States
Pd0053 50397
Las Vegas, Nevada, United States
Pd0053 50299
New Brunswick, New Jersey, United States
Pd0053 50077
New York, New York, United States
Pd0053 50521
New York, New York, United States
Pd0053 50119
New York, New York, United States
Pd0053 50530
Stony Brook, New York, United States
Pd0053 50535
Williamsville, New York, United States
Pd0053 50372
Cleveland, Ohio, United States
Pd0053 50311
Cleveland, Ohio, United States
Pd0053 50255
Columbus, Ohio, United States
Pd0053 50527
Toledo, Ohio, United States
Pd0053 50398
Tulsa, Oklahoma, United States
Pd0053 50510
Portland, Oregon, United States
Pd0053 50526
Philadelphia, Pennsylvania, United States
Pd0053 50084
Charleston, South Carolina, United States
Pd0053 50532
Knoxville, Tennessee, United States
Pd0053 50543
Memphis, Tennessee, United States
Pd0053 50525
Houston, Texas, United States
Pd0053 50113
Houston, Texas, United States
Pd0053 50400
San Antonio, Texas, United States
Pd0053 50107
Burlington, Vermont, United States
Pd0053 50542
Charlottesville, Virginia, United States
Pd0053 50410
Fairfax, Virginia, United States
Pd0053 50534
Virginia Beach, Virginia, United States
Pd0053 50292
Kirkland, Washington, United States
Pd0053 50419
Spokane, Washington, United States
Pd0053 50402
Crab Orchard, West Virginia, United States
Pd0053 50374
Calgary, , Canada
Pd0053 50390
Kelowna, , Canada
Pd0053 50387
Ottawa, , Canada
Pd0053 50389
Toronto, , Canada
Pd0053 40197
Amiens, , France
Pd0053 40527
Bordeaux, , France
Pd0053 40424
Créteil, , France
Pd0053 40526
Lille, , France
Pd0053 40130
Marseille, , France
Pd0053 40635
Nantes, , France
Pd0053 40524
Nîmes, , France
Pd0053 40525
Paris, , France
Pd0053 40131
Strasbourg, , France
Pd0053 40528
Toulouse, , France
Pd0053 40515
Berlin, , Germany
Pd0053 40138
Bonn, , Germany
Pd0053 40530
Dresden, , Germany
Pd0053 40711
Erbach im Odenwald, , Germany
Pd0053 40023
Erlangen, , Germany
Pd0053 40710
Essen, , Germany
Pd0053 40532
Haag in Oberbayern, , Germany
Pd0053 40024
Hanover, , Germany
Pd0053 40249
Kiel, , Germany
Pd0053 40174
Mainz, , Germany
Pd0053 40529
Marburg, , Germany
Pd0053 40531
Regensburg, , Germany
Pd0053 40555
Brescia, , Italy
Pd0053 40533
Padua, , Italy
Pd0053 40257
Roma, , Italy
Pd0053 40534
Roma, , Italy
Pd0053 40697
Roma, , Italy
Pd0053 40359
Nijmegen, , Netherlands
Pd0053 40694
Bydgoszcz, , Poland
Pd0053 40719
Jelenia Góra, , Poland
Pd0053 40539
Katowice, , Poland
Pd0053 40538
Krakow, , Poland
Pd0053 40696
Krakow, , Poland
Pd0053 40700
Lodz, , Poland
Pd0053 40702
Lublin, , Poland
Pd0053 40535
Oświęcim, , Poland
Pd0053 40536
Warsaw, , Poland
Pd0053 40699
Warsaw, , Poland
Pd0053 40705
Warsaw, , Poland
Pd0053 40045
A Coruña, , Spain
Pd0053 40159
Barcelona, , Spain
Pd0053 40267
Barcelona, , Spain
Pd0053 40046
Córdoba, , Spain
Pd0053 40540
Madrid, , Spain
Pd0053 40542
Móstoles, , Spain
Pd0053 40352
Pamplona, , Spain
Pd0053 40541
San Sebastián, , Spain
Pd0053 40049
Seville, , Spain
Pd0053 40175
London, , United Kingdom
Pd0053 40543
London, , United Kingdom
Pd0053 40698
London, , United Kingdom
Pd0053 40544
Motherwell, , United Kingdom
Pd0053 40306
Newcastle upon Tyne, , United Kingdom
Pd0053 40457
Plymouth, , United Kingdom
Countries
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References
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Price DL, Khan A, Angers R, Cardenas A, Prato MK, Bani M, Bonhaus DW, Citron M, Biere AL. In vivo effects of the alpha-synuclein misfolding inhibitor minzasolmin supports clinical development in Parkinson's disease. NPJ Parkinsons Dis. 2023 Jul 17;9(1):114. doi: 10.1038/s41531-023-00552-7.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-003265-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PD0053
Identifier Type: -
Identifier Source: org_study_id
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