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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
207
Change from Baseline to Visit 9 (Day 70) in the average number of hours/day of OFF time, as assessed by the study participant-completed Hauser PD symptoms diary over 3 consecutive days
The Hauser Parkinson's disease (PD) symptoms diary is a study participant-completed diary that records the daily ON time and OFF time of study participants with PD with motor fluctuations and dyskinesia.
Time frame: From Baseline (Day 1) to Visit 9 (Day 70)
Incidence of treatment-emergent adverse events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs are defined as AEs starting after the time of first IMP administration up to and including 2 weeks after the final dose.
Time frame: From Baseline (Day 1) to End of Safety Follow-up (up to Week 12)
Incidence of treatment-emergent serious adverse events (SAEs)
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent disability/incapacity * Is a congenital anomaly/birth defect * Important medical events Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of investigational medicinal product (IMP).
Time frame: From Baseline (Day 1) to End of Safety Follow-up (up to Week 12)
Incidence of TEAEs leading to withdrawal from the study
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IMP. TEAEs are defined as AEs starting after the time of first IMP administration up to and including 2 weeks after the final dose.
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Pd0060 50506
Phoenix, Arizona, United States
Pd0060 50590
Scottsdale, Arizona, United States
Pd0060 50608
Little Rock, Arkansas, United States
Pd0060 50519
Fountain Valley, California, United States
Pd0060 50428
Fresno, California, United States
Pd0060 50601
Loma Linda, California, United States
Pd0060 50589
Los Alamitos, California, United States
Pd0060 50587
Los Angeles, California, United States
Pd0060 50452
Pasadena, California, United States
Pd0060 50598
Englewood, Colorado, United States
...and 51 more locations
Time frame: From Baseline (Day 1) to End of Safety Follow-up (up to Week 12)
Average Ctrough of UCB0022 and its active N-desmethyl-UCB0022 metabolite at Visit 9 (Day 70)
Ctrough: The predose observed plasma concentration (average, per visit) will be plotted and depicted graphically to assess trajectory to steady-state for parent and active metabolites.
Time frame: at Visit 9 (Day 70)