Phase
Condition
N/ATreatment
Placebo
UCB0022
Clinical Study ID
Ages 35-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Study participant must be 35 to 85 years of age (inclusive) at the time of signingthe informed consent form (ICF)
Study participant is diagnosed with Parkinson's disease (PD) (based on the UnitedKingdom Parkinson's Disease Society Brain Bank Diagnostic criteria performed at theScreening Visit) and diagnosed ≥5 years before the Screening Visit (based onhistorical 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 differentiatebetween the ON and OFF states
Study participant is responsive to levodopa and currently receiving treatment withoral daily doses of levodopa combination (levodopa/carbidopa orlevodopa/benserazide) with or without oral adjunctive antiparkinsonian therapies (based on historical clinical data)
Study participant has disease severity Stages I-III (modified Hoehn and Yahrstaging) during ON state
Study participant agrees to not post personal medical data or information related tothe 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 TreatmentPeriod and for at least 2 weeks after the last dose of study treatment andrefrain from donating sperm during this period
A female study participant must not be a woman of childbearing potential (WOCBP)
Exclusion
Exclusion Criteria:
Study participant is diagnosed with any form of Parkinsonism other than idiopathicPD (eg, atypical or secondary Parkinsonism)
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 byMovement 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 otherpsychiatric condition within the past 5 years, that, as per investigator opinion,could jeopardize or would compromise the study participant's ability to participatein 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 hypertensiveencephalopathy, unless the underlying cause was unequivocally identified and hasbeen removed
Study participant has orthostatic hypotension requiring medication or a currenthistory of "clinically significant" orthostatic hypotension as per theinvestigator's opinion (eg, recurrent orthostatic presyncope or syncope)
Study participant has a history over the past 12 months or between the Screening andBaseline 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%)
Study Design
Connect with a study center
Pd0060 50506
Phoenix, Arizona 85004
United StatesSite Not Available
Pd0060 50590
Scottsdale, Arizona 85258
United StatesSite Not Available
Pd0060 50608
Little Rock, Arkansas 72205
United StatesSite Not Available
Pd0060 50519
Fountain Valley, California 92708
United StatesSite Not Available
Pd0060 50428
Fresno, California 93710
United StatesSite Not Available
Pd0060 50601
Loma Linda, California 92354
United StatesSite Not Available
Pd0060 50589
Los Alamitos, California 90720
United StatesSite Not Available
Pd0060 50587
Los Angeles, California 90033
United StatesSite Not Available
Pd0060 50452
Pasadena, California 91106
United StatesSite Not Available
Pd0060 50598
Englewood, Colorado 80113
United StatesSite Not Available
Pd0060 50628
New Haven, Connecticut 06519
United StatesSite Not Available
Pd0060 50610
Newark, Delaware 19713
United StatesSite Not Available
Pd0060 50600
Altamonte Springs, Florida 32714
United StatesSite Not Available
Pd0060 50616
Aventura, Florida 33180
United StatesSite Not Available
Pd0060 50596
Boca Raton, Florida 33486
United StatesSite Not Available
Pd0060 50524
Bradenton, Florida 34205
United StatesSite Not Available
Pd0060 50647
DeLand, Florida 32720
United StatesSite Not Available
Pd0060 50577
Doral, Florida 33172
United StatesSite Not Available
Pd0060 50584
Hollywood, Florida 33021
United StatesSite Not Available
Pd0060 50449
Miami, Florida 33133
United StatesSite Not Available
Pd0060 50579
Miami, Florida 33125
United StatesSite Not Available
Pd0060 50580
Miami, Florida 33176
United StatesSite Not Available
Pd0060 50582
Miami, Florida 33122
United StatesSite Not Available
Pd0060 50597
Naples, Florida 34105
United StatesSite Not Available
Pd0060 50591
Ocala, Florida 34470
United StatesSite Not Available
Pd0060 50605
Port Orange, Florida 32127
United StatesSite Not Available
Pd0060 50620
Saint Petersburg, Florida 33710
United StatesSite Not Available
Pd0060 50603
Tampa, Florida 33609
United StatesSite Not Available
Pd0060 50624
Vero Beach, Florida 32960
United StatesSite Not Available
Pd0060 50585
Winter Park, Florida 32789
United StatesSite Not Available
Pd0060 50075
Augusta, Georgia 30912
United StatesSite Not Available
Pd0060 50578
Decatur, Georgia 30033
United StatesSite Not Available
Pd0060 50595
Indianapolis, Indiana 46256
United StatesSite Not Available
Pd0060 50319
Iowa City, Iowa 52242
United StatesSite Not Available
Pd0060 50074
Kansas City, Kansas 66160
United StatesSite Not Available
Pd0060 50561
Lexington, Kentucky 40536-0284
United StatesSite Not Available
Pd0060 50586
Louisville, Kentucky 40202
United StatesSite Not Available
Pd0060 50085
Boston, Massachusetts 02215
United StatesSite Not Available
Pd0060 50615
Boston, Massachusetts 02118
United StatesSite Not Available
Pd0060 50627
North Dartmouth, Massachusetts 02747
United StatesSite Not Available
Pd0060 50110
Ann Arbor, Michigan 48109-0944
United StatesSite Not Available
Pd0060 50545
East Lansing, Michigan 48824
United StatesSite Not Available
Pd0060 50386
Farmington Hills, Michigan 48334
United StatesSite Not Available
Pd0060 50602
Farmington Hills, Michigan 48334
United StatesSite Not Available
Pd0060 50613
Grand Rapids, Michigan 49503
United StatesSite Not Available
Pd0060 50611
Las Vegas, Nevada 89106
United StatesSite Not Available
Pd0060 50621
Albuquerque, New Mexico 87106
United StatesSite Not Available
Pd0060 50521
New York, New York 10029
United StatesSite Not Available
Pd0060 50614
New York, New York 10021
United StatesSite Not Available
Pd0060 50612
Raleigh, North Carolina 27607
United StatesSite Not Available
Pd0060 50087
Centerville, Ohio 45459
United StatesSite Not Available
Pd0060 50622
Cleveland, Ohio 44195
United StatesSite Not Available
Pd0060 50076
Columbus, Ohio 43221
United StatesSite Not Available
Pd0060 50604
Dayton, Ohio 45449
United StatesSite Not Available
Pd0060 50527
Toledo, Ohio 43614
United StatesSite Not Available
Pd0060 50398
Tulsa, Oklahoma 74136
United StatesSite Not Available
Pd0060 50607
Portland, Oregon 97210
United StatesSite Not Available
Pd0060 50619
Rock Hill, South Carolina 29732
United StatesSite Not Available
Pd0060 50588
Dallas, Texas 75243-1188
United StatesSite Not Available
Pd0060 50496
Round Rock, Texas 78681
United StatesSite Not Available
Pd0060 50568
San Antonio, Texas 78229
United StatesSite Not Available
Pd0060 50537
Salt Lake City, Utah 84108
United StatesSite Not Available
Pd0060 50609
Charlottesville, Virginia 22903
United StatesSite Not Available
Pd0060 50143
Henrico, Virginia 23233
United StatesSite Not Available
Pd0060 50534
Virginia Beach, Virginia 23456
United StatesSite Not Available
Pd0060 50440
Bellevue, Washington 98004
United StatesSite Not Available
Pd0060 50292
Kirkland, Washington 98034
United StatesSite Not Available
Pd0060 50419
Spokane, Washington 99202
United StatesSite Not Available
Pd0060 50402
Crab Orchard, West Virginia 25827
United StatesSite Not Available
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