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NCT06055985CompletedPhase 2

A Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson's Disease

A Multicenter Phase 2, Double-blind, Placebo-controlled, Randomized, Parallel-group Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of UCB0022 in Study Participants With Advanced Parkinson's Disease

Source: ClinicalTrials.gov · Last updated 6 Apr 2026

Brief summary (registry, in English)

The primary purpose of this study is to demonstrate the superiority of UCB0022 as an adjunctive treatment to stable dose of standard-of-care (SoC) (including at least levodopa therapy) over placebo with regard to motor fluctuations time spent in the OFF state (OFF time) in study participants with advanced Parkinson's Disease (PD).

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
207 (actual)
First submitted
20 Sept 2023
Start date
Nov 2023
Primary completion date
Mar 2025
Lead sponsor
UCB Biopharma SRL
NCT number
NCT06055985

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 207
  • From Nov 2023 to the primary completion date, Mar 2025
  • 61 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Study participant is diagnosed with dementia or has important cognitive dysfunction, as determined by Montreal Cognitive Assessment (MoCA) \<23 at screening
  • Study participant has a history of neurosurgical intervention for PD (including DBS, thalamotomy, and experimental cell therapy or gene therapy)
  • Participant has a severe peak dose or biphasic dyskinesia at screening, defined by Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) items 4.2 score 4 or as per investigator opinion
  • Participant has a history of major depression or psychotic disorder or any other psychiatric condition within the past 5 years, that, as per investigator opinion, could jeopardize or would compromise the study participant's ability to participate in the study
  • Study participant has a history of narrow angle glaucoma
  • Study participant has a history of melanoma
  • Study participant has current untreated hypertension
  • Study participant has a history of hypertensive crisis and/or hypertensive encephalopathy, unless the underlying cause was unequivocally identified and has been removed
  • Study participant has orthostatic hypotension requiring medication or a current history of "clinically significant" orthostatic hypotension as per the investigator's opinion (eg, recurrent orthostatic presyncope or syncope)

Lab values

  • Study participant has a history over the past 12 months or between the Screening and Baseline Visits of any clinically significant arrythmia, myocardial infarction, stroke, transient ischemic attack, moderate or severe congestive heart failure (either New York Heart Association Class III or IV or known ejection fraction \<40%)

Other

  • Study participant is diagnosed with any form of Parkinsonism other than idiopathic PD (eg, atypical or secondary Parkinsonism)

Who the study is looking for

  • Study participant must be 35 to 85 years of age (inclusive) at the time of signing the informed consent form (ICF)
  • Study participant is diagnosed with Parkinson's disease (PD) (based on the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic criteria performed at the Screening Visit) and diagnosed ≥5 years before the Screening Visit (based on historical medical- information documented by the investigator)
  • Study participant has significant daily motor fluctuations
  • Study participant is able to complete a Hauser PD symptoms diary and differentiate between the ON and OFF states
  • Study participant is responsive to levodopa and currently receiving treatment with oral daily doses of levodopa combination (levodopa/carbidopa or levodopa/benserazide) with or without oral adjunctive antiparkinsonian therapies (based on historical clinical data)
  • Study participant has disease severity Stages I-III (modified Hoehn and Yahr staging) during ON state
  • Study participant agrees to not post personal medical data or information related to the study on social media until study completion
  • Study participant has body weight ≥45 kg and body mass index within 18 to 30 kg/m\^2 (inclusive)
  • Study participant may be male or female:
    • A male study participant must agree to use contraception during the Treatment Period and for at least 2 weeks after the last dose of study treatment and refrain from donating sperm during this period
    • A female study participant must not be a woman of childbearing potential (WOCBP)

Age in the registry: 35 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (61)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Pd0060 50600
Coordinator of this site? Confirm its status
Altamonte SpringsUnited StatesUnknown status
Pd0060 50110
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Ann ArborUnited StatesUnknown status
Pd0060 50075
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AugustaUnited StatesUnknown status
Pd0060 50616
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AventuraUnited StatesUnknown status
Pd0060 50440
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BellevueUnited StatesUnknown status
Pd0060 50596
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Boca RatonUnited StatesUnknown status
Pd0060 50085
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
Pd0060 50615
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BostonUnited StatesUnknown status
Pd0060 50524
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BradentonUnited StatesUnknown status
Pd0060 50087
Coordinator of this site? Confirm its status
CentervilleUnited StatesUnknown status
Pd0060 50622
Coordinator of this site? Confirm its status
ClevelandUnited StatesUnknown status
Pd0060 50076
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ColumbusUnited StatesUnknown status
Pd0060 50402
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Crab OrchardUnited StatesUnknown status
Pd0060 50604
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DaytonUnited StatesUnknown status
Pd0060 50647
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DeLandUnited StatesUnknown status
Pd0060 50577
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DoralUnited StatesUnknown status
Pd0060 50545
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East LansingUnited StatesUnknown status
Pd0060 50598
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EnglewoodUnited StatesUnknown status
Pd0060 50386
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Farmington HillsUnited StatesUnknown status
Pd0060 50519
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Fountain ValleyUnited StatesUnknown status
Pd0060 50428
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FresnoUnited StatesUnknown status
Pd0060 50613
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Grand RapidsUnited StatesUnknown status
Pd0060 50143
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HenricoUnited StatesUnknown status
Pd0060 50584
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HollywoodUnited StatesUnknown status
Pd0060 50595
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IndianapolisUnited StatesUnknown status
Pd0060 50319
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Iowa CityUnited StatesUnknown status
Pd0060 50074
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Kansas CityUnited StatesUnknown status
Pd0060 50292
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KirklandUnited StatesUnknown status
Pd0060 50561
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LexingtonUnited StatesUnknown status
Pd0060 50608
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Little RockUnited StatesUnknown status
Pd0060 50601
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Loma LindaUnited StatesUnknown status
Pd0060 50589
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Los AlamitosUnited StatesUnknown status
Pd0060 50587
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Los AngelesUnited StatesUnknown status
Pd0060 50580
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MiamiUnited StatesUnknown status
Pd0060 50582
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
Pd0060 50579
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MiamiUnited StatesUnknown status
Pd0060 50449
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MiamiUnited StatesUnknown status
Pd0060 50597
Coordinator of this site? Confirm its status
NaplesUnited StatesUnknown status
Pd0060 50610
Coordinator of this site? Confirm its status
NewarkUnited StatesUnknown status
Pd0060 50628
Coordinator of this site? Confirm its status
New HavenUnited StatesUnknown status
Pd0060 50614
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New YorkUnited StatesUnknown status
Pd0060 50521
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New YorkUnited StatesUnknown status
Pd0060 50627
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North DartmouthUnited StatesUnknown status
Pd0060 50591
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OcalaUnited StatesUnknown status
Pd0060 50452
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PasadenaUnited StatesUnknown status
Pd0060 50506
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PhoenixUnited StatesUnknown status
Pd0060 50607
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PortlandUnited StatesUnknown status
Pd0060 50605
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Port OrangeUnited StatesUnknown status
Pd0060 50612
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RaleighUnited StatesUnknown status
Pd0060 50619
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Rock HillUnited StatesUnknown status
Pd0060 50496
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Round RockUnited StatesUnknown status
Pd0060 50537
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Salt Lake CityUnited StatesUnknown status
Pd0060 50568
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San AntonioUnited StatesUnknown status
Pd0060 50590
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ScottsdaleUnited StatesUnknown status
Pd0060 50419
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SpokaneUnited StatesUnknown status
Pd0060 50620
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St. PetersburgUnited StatesUnknown status
Pd0060 50603
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TampaUnited StatesUnknown status
Pd0060 50527
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ToledoUnited StatesUnknown status
Pd0060 50398
Coordinator of this site? Confirm its status
TulsaUnited StatesUnknown status
Pd0060 50534
Coordinator of this site? Confirm its status
Virginia BeachUnited StatesUnknown status
Pd0060 50585
Coordinator of this site? Confirm its status
Winter ParkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.