Placebo
OtherStudy participants will receive placebo orally administered as tablet at pre-specified time points during the study.
NCT Number: NCT06055985
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).
Looking for future studies?
Notify Me35 year–85 year
All sexes
Interventional
Phase 2
Pd0060 50506, Phoenix, Arizona, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Study participants will receive placebo orally administered as tablet at pre-specified time points during the study.
Study participants will receive UCB0022 dose A or B orally administered as tablet at pre-specified time points during the Treatment Period.
Time frame: From Baseline (Day 1) to Visit 9 (Day 70)
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 End of Safety Follow-up (up to Week 12)
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)
A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose:
Time frame: From Baseline (Day 1) to End of Safety Follow-up (up to Week 12)
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.
Time frame: 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.
UCB Biopharma SRL
Industry
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
Acronym: ATLANTIS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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