An Extension Study to Evaluate the Long-Term Efficacy, Safety and Tolerability of Minzasolmin (UCB0599) in Study Participants With Parkinson's Disease
- Conditions
- Parkinson's Disease
- Interventions
- Drug: Minzasolmin (UCB0599)
- Registration Number
- NCT05543252
- Lead Sponsor
- UCB Biopharma SRL
- Brief Summary
The purpose of the study is to estimate the pharmacodynamic effects of minzasolmin (UCB0599) on brain pathophysiology in Early-start versus Delayed-start participants originally diagnosed with new onset Parkinson's disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 374
Not provided
- Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study
- A female study participant who tests positive for pregnancy, plans to get pregnant during the participation in the study, or who is breastfeeding
- Study participant had previously participated in PD0055
- Study participant meets any withdrawal criteria in PD0053 (NCT04658186)
- Study participants wearing any kind of implantable active device, including cardiac pacemakers, pumps, and implantable cardioverters, will be excluded from using Digital Health Technology, but may participate in the main study
- Study participant does not agree to refrain from donating blood or blood products or other body fluids
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Minzasolmin (UCB0599) Low Dose Arm Minzasolmin (UCB0599) Participants will receive a predefined low dosage of minzasolmin (UCB0599) during the Treatment Period. Minzasolmin (UCB0599) High Dose Arm Minzasolmin (UCB0599) Participants will receive a predefined high dosage of minzasolmin (UCB0599) during the Treatment Period.
- Primary Outcome Measures
Name Time Method Baseline adjusted Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT) whole striatum SBR at PD0055 Month 18 From Baseline up to Month 18 The change from baseline (screening) in mean striatum specific binding ratios (SBR) will be assessed by Dopamine Transporter Imaging with Single Photon Emission Computed Tomography using 123I-Ioflupane as radiopharmaceutical.
Baseline will refer to PD0053 (NCT04658186) Screening Visit date.
- Secondary Outcome Measures
Name Time Method Incidence of TEAEs leading to withdrawal from study From Baseline to the Safety Follow-up Visit (Month 31) Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Cumulative Levodopa Equivalent Daily Dose; (LEDD) at PD0055 Month 18 From Baseline up to Month 18 The Cumulative Levodopa Equivalent Daily Dose (LEDD) will be calculated for each participant at each visit and at the end of study. This is the sum of all the LEDDs taken up to that visit. Any changes in medication (type, dose, or dosing regimen) should be accounted for when calculating cumulative doses.
Incidence of treatment-emergent adverse event (TEAEs) From Baseline to the Safety Follow-up Visit (Month 31) Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Incidence of serious adverse events (SAEs) From Baseline to the Safety Follow-up Visit (Month 31) Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Serious criteria of death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect . Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Trial Locations
- Locations (96)
Pd0055 40540
🇪🇸Madrid, Spain
Pd0055 40542
🇪🇸Móstoles, Spain
Pd0055 40352
🇪🇸Pamplona, Spain
Pd0055 40541
🇪🇸San Sebastián, Spain
Pd0055 40049
🇪🇸Sevilla, Spain
Pd0055 40175
🇬🇧London, United Kingdom
Pd0055 40543
🇬🇧London, United Kingdom
Pd0055 40698
🇬🇧London, United Kingdom
Pd0055 40544
🇬🇧Motherwell, United Kingdom
Pd0055 40306
🇬🇧Newcastle Upon Tyne, United Kingdom
Pd0055 40457
🇬🇧Plymouth, United Kingdom
Pd0055 50538
🇺🇸Farmington, Connecticut, United States
Pd0055 50396
🇺🇸Boca Raton, Florida, United States
Pd0055 50524
🇺🇸Bradenton, Florida, United States
Pd0055 50394
🇺🇸Tampa, Florida, United States
Pd0055 50544
🇺🇸Augusta, Georgia, United States
Pd0055 50401
🇺🇸Chicago, Illinois, United States
Pd0055 50310
🇺🇸Chicago, Illinois, United States
Pd0055 50399
🇺🇸Winfield, Illinois, United States
Pd0055 50549
🇺🇸Iowa City, Iowa, United States
Pd0055 50074
🇺🇸Kansas City, Kansas, United States
Pd0055 50121
🇺🇸Lexington, Kentucky, United States
Pd0055 50395
🇺🇸New Orleans, Louisiana, United States
Pd0055 50547
🇺🇸Baltimore, Maryland, United States
Pd0055 50243
🇺🇸Boston, Massachusetts, United States
Pd0055 50546
🇺🇸Worcester, Massachusetts, United States
Pd0055 50386
🇺🇸Farmington Hills, Michigan, United States
Pd0055 50536
🇺🇸Saint Paul, Minnesota, United States
Pd0055 50397
🇺🇸Las Vegas, Nevada, United States
Pd0055 50530
🇺🇸Stony Brook, New York, United States
Pd0055 50535
🇺🇸Williamsville, New York, United States
Pd0055 50372
🇺🇸Cleveland, Ohio, United States
Pd0055 50311
🇺🇸Cleveland, Ohio, United States
Pd0055 50255
🇺🇸Columbus, Ohio, United States
Pd0055 50398
🇺🇸Tulsa, Oklahoma, United States
Pd0055 50084
🇺🇸Charleston, Oregon, United States
Pd0055 50526
🇺🇸Philadelphia, Pennsylvania, United States
Pd0055 50543
🇺🇸Memphis, Tennessee, United States
Pd0055 50113
🇺🇸Houston, Texas, United States
Pd0055 50525
🇺🇸Houston, Texas, United States
Pd0055 50400
🇺🇸San Antonio, Texas, United States
Pd0055 50107
🇺🇸Burlington, Vermont, United States
Pd0055 50410
🇺🇸Fairfax, Virginia, United States
Pd0055 50534
🇺🇸Virginia Beach, Virginia, United States
Pd0055 50292
🇺🇸Kirkland, Washington, United States
Pd0055 50402
🇺🇸Crab Orchard, West Virginia, United States
Pd0055 50374
🇨🇦Calgary, Canada
Pd0055 50387
🇨🇦Ottawa, Canada
Pd0055 50389
🇨🇦Toronto, Canada
Pd0055 40527
🇫🇷Bordeaux, France
Pd0055 40424
🇫🇷Créteil, France
Pd0055 40526
🇫🇷Lille, France
Pd0055 40130
🇫🇷Marseille, France
Pd0055 40635
🇫🇷Nantes, France
Pd0055 40524
🇫🇷Nimes, France
Pd0055 40525
🇫🇷Paris, France
Pd0055 40131
🇫🇷Strasbourg, France
Pd0055 40528
🇫🇷Toulouse, France
Pd0055 40515
🇩🇪Berlin, Germany
Pd0055 40138
🇩🇪Bonn, Germany
Pd0055 40530
🇩🇪Dresden, Germany
Pd0055 40711
🇩🇪Erbach, Germany
Pd0055 40023
🇩🇪Erlangen, Germany
Pd0055 40710
🇩🇪Essen, Germany
Pd0055 40532
🇩🇪Haag in Oberbayern, Germany
Pd0055 40249
🇩🇪Kiel, Germany
Pd0055 40174
🇩🇪Mainz, Germany
Pd0055 40529
🇩🇪Marburg, Germany
Pd0055 40531
🇩🇪Regensburg, Germany
Pd0055 40555
🇮🇹Brescia, Italy
Pd0055 40533
🇮🇹Padova, Italy
Pd0055 40257
🇮🇹Roma, Italy
Pd0055 40534
🇮🇹Roma, Italy
Pd0055 40697
🇮🇹Terni, Italy
Pd0055 40359
🇳🇱Nijmegen, Netherlands
Pd0055 40694
🇵🇱Bydgoszcz, Poland
Pd0055 40719
🇵🇱Jelenia Gora, Poland
Pd0055 40539
🇵🇱Katowice, Poland
Pd0055 40538
🇵🇱Krakow, Poland
Pd0055 40696
🇵🇱Krakow, Poland
Pd0055 40700
🇵🇱Lodz, Poland
Pd0055 40702
🇵🇱Lublin, Poland
Pd0055 40535
🇵🇱Oswiecim, Poland
Pd0055 40536
🇵🇱Warszawa, Poland
Pd0055 40699
🇵🇱Warszawa, Poland
Pd0055 40705
🇵🇱Warszawa, Poland
Pd0055 40045
🇪🇸A Coruña, Spain
Pd0055 40159
🇪🇸Barcelona, Spain
Pd0055 40267
🇪🇸Barcelona, Spain
Pd0055 40046
🇪🇸Cordoba, Spain
Pd0055 50506
🇺🇸Phoenix, Arizona, United States
Pd0055 50519
🇺🇸Fountain Valley, California, United States
Pd0055 50385
🇺🇸Fresno, California, United States
Pd0055 50118
🇺🇸Los Angeles, California, United States
Pd0055 50531
🇺🇸Englewood, Colorado, United States
Pd0055 50392
🇺🇸Danbury, Connecticut, United States