Phase
Condition
N/ATreatment
UCB0022
Placebo
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 50506
Phoenix 5308655, Arizona 5551752 85004
United StatesSite Not Available
Pd0060 50590
Scottsdale 5313457, Arizona 5551752 85258
United StatesSite Not Available
Pd0060 50608
Little Rock, Arkansas 72205
United StatesSite Not Available
Pd0060 50608
Little Rock 4119403, Arkansas 4099753 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 50519
Fountain Valley 5350207, California 5332921 92708
United StatesSite Not Available
Pd0060 50428
Fresno 5350937, California 5332921 93710
United StatesSite Not Available
Pd0060 50601
Loma Linda 5367696, California 5332921 92354
United StatesSite Not Available
Pd0060 50589
Los Alamitos 5368304, California 5332921 90720
United StatesSite Not Available
Pd0060 50587
Los Angeles 5368361, California 5332921 90033
United StatesSite Not Available
Pd0060 50452
Pasadena 5381396, California 5332921 91106
United StatesSite Not Available
Pd0060 50598
Englewood, Colorado 80113
United StatesSite Not Available
Pd0060 50598
Englewood 5421250, Colorado 5417618 80113
United StatesSite Not Available
Pd0060 50628
New Haven, Connecticut 06519
United StatesSite Not Available
Pd0060 50628
New Haven 4839366, Connecticut 4831725 06519
United StatesSite Not Available
Pd0060 50610
Newark, Delaware 19713
United StatesSite Not Available
Pd0060 50610
Newark 4143861, Delaware 4142224 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 50600
Altamonte Springs 4145941, Florida 4155751 32714
United StatesSite Not Available
Pd0060 50616
Aventura 4146429, Florida 4155751 33180
United StatesSite Not Available
Pd0060 50596
Boca Raton 4148411, Florida 4155751 33486
United StatesSite Not Available
Pd0060 50524
Bradenton 4148708, Florida 4155751 34205
United StatesSite Not Available
Pd0060 50647
DeLand 4152890, Florida 4155751 32720
United StatesSite Not Available
Pd0060 50577
Doral 4153471, Florida 4155751 33172
United StatesSite Not Available
Pd0060 50584
Hollywood 4158928, Florida 4155751 33021
United StatesSite Not Available
Pd0060 50449
Miami 4164138, Florida 4155751 33133
United StatesSite Not Available
Pd0060 50579
Miami 4164138, Florida 4155751 33125
United StatesSite Not Available
Pd0060 50580
Miami 4164138, Florida 4155751 33176
United StatesSite Not Available
Pd0060 50582
Miami 4164138, Florida 4155751 33122
United StatesSite Not Available
Pd0060 50597
Naples 4165565, Florida 4155751 34105
United StatesSite Not Available
Pd0060 50591
Ocala 4166673, Florida 4155751 34470
United StatesSite Not Available
Pd0060 50605
Port Orange 4169156, Florida 4155751 32127
United StatesSite Not Available
Pd0060 50620
St. Petersburg 4171563, Florida 4155751 33710
United StatesSite Not Available
Pd0060 50603
Tampa 4174757, Florida 4155751 33609
United StatesSite Not Available
Pd0060 50585
Winter Park 4178560, Florida 4155751 32789
United StatesSite Not Available
Pd0060 50075
Augusta, Georgia 30912
United StatesSite Not Available
Pd0060 50578
Decatur, Georgia 30033
United StatesSite Not Available
Pd0060 50075
Augusta 4180531, Georgia 4197000 30912
United StatesSite Not Available
Pd0060 50595
Indianapolis, Indiana 46256
United StatesSite Not Available
Pd0060 50595
Indianapolis 4259418, Indiana 4921868 46256
United StatesSite Not Available
Pd0060 50319
Iowa City, Iowa 52242
United StatesSite Not Available
Pd0060 50319
Iowa City 4862034, Iowa 4862182 52242
United StatesSite Not Available
Pd0060 50074
Kansas City, Kansas 66160
United StatesSite Not Available
Pd0060 50074
Kansas City 4273837, Kansas 4273857 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 50561
Lexington 4297983, Kentucky 6254925 40536-0284
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 50085
Boston 4930956, Massachusetts 6254926 02215
United StatesSite Not Available
Pd0060 50615
Boston 4930956, Massachusetts 6254926 02118
United StatesSite Not Available
Pd0060 50627
North Dartmouth 4945601, Massachusetts 6254926 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 50110
Ann Arbor 4984247, Michigan 5001836 48109-0944
United StatesSite Not Available
Pd0060 50545
East Lansing 4991640, Michigan 5001836 48824
United StatesSite Not Available
Pd0060 50386
Farmington Hills 4992523, Michigan 5001836 48334
United StatesSite Not Available
Pd0060 50613
Grand Rapids 4994358, Michigan 5001836 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 50521
New York 5128581, New York 5128638 10029
United StatesSite Not Available
Pd0060 50614
New York 5128581, New York 5128638 10021
United StatesSite Not Available
Pd0060 50612
Raleigh, North Carolina 27607
United StatesSite Not Available
Pd0060 50612
Raleigh 4487042, North Carolina 4482348 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 50087
Centerville 4508204, Ohio 5165418 45459
United StatesSite Not Available
Pd0060 50622
Cleveland 5150529, Ohio 5165418 44195
United StatesSite Not Available
Pd0060 50076
Columbus 4509177, Ohio 5165418 43221
United StatesSite Not Available
Pd0060 50604
Dayton 4509884, Ohio 5165418 45449
United StatesSite Not Available
Pd0060 50527
Toledo 5174035, Ohio 5165418 43614
United StatesSite Not Available
Pd0060 50398
Tulsa, Oklahoma 74136
United StatesSite Not Available
Pd0060 50398
Tulsa 4553433, Oklahoma 4544379 74136
United StatesSite Not Available
Pd0060 50607
Portland, Oregon 97210
United StatesSite Not Available
Pd0060 50607
Portland 5746545, Oregon 5744337 97210
United StatesSite Not Available
Pd0060 50619
Rock Hill, South Carolina 29732
United StatesSite Not Available
Pd0060 50619
Rock Hill 4593142, South Carolina 4597040 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 50496
Round Rock 4724129, Texas 4736286 78681
United StatesSite Not Available
Pd0060 50568
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available
Pd0060 50537
Salt Lake City, Utah 84108
United StatesSite Not Available
Pd0060 50537
Salt Lake City 5780993, Utah 5549030 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 50143
Henrico 4763729, Virginia 6254928 23233
United StatesSite Not Available
Pd0060 50534
Virginia Beach 4791259, Virginia 6254928 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 50440
Bellevue 5786882, Washington 5815135 98004
United StatesSite Not Available
Pd0060 50292
Kirkland 5799841, Washington 5815135 98034
United StatesSite Not Available
Pd0060 50419
Spokane 5811696, Washington 5815135 99202
United StatesSite Not Available
Pd0060 50402
Crab Orchard, West Virginia 25827
United StatesSite Not Available
Pd0060 50402
Crab Orchard 4803150, West Virginia 4826850 25827
United StatesSite Not Available

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