UCB0599 Low Dose Arm for Parkinson's Disease (PD)
Phase-Based Progress Estimates
Effectiveness
Safety
Pd0055 50397, Las Vegas, NV
Parkinson's Disease (PD)+1 More
UCB0599 - DrugEligibility
18+
All Sexes
What conditions do you have?
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Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary
The purpose of the study is to estimate the pharmacodynamic effects of UCB0599 on brain pathophysiology in Early-start versus Delayed-start participants originally diagnosed with new onset Parkinson's disease.
Eligible Conditions
- Parkinson's Disease (PD)
Treatment Effectiveness
Effectiveness Progress
Other trials for Parkinson's Disease (PD)
Study Objectives
2 Primary · 4 Secondary · Reporting Duration: From Baseline to the Safety Follow-up Visit (Month 31)
Month 31
Incidence of TEAEs leading to withdrawal from study
Incidence of serious adverse events (SAEs)
Incidence of treatment-emergent adverse event (TEAEs)
Month 18
Baseline adjusted Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT) whole striatum SBR at PD0055 Month 18
Baseline adjusted Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT)T whole striatum SBR at PD0055 Month 18
Cumulative Levodopa Equivalent Daily Dose; (LEDD) at PD0055 Month 18
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Other trials for Parkinson's Disease (PD)
Trial Design
2 Treatment Groups
UCB0599 Low Dose Arm
1 of 2
UCB0599 High Dose Arm
1 of 2
Experimental Treatment
270 Total Participants · 2 Treatment Groups
Primary Treatment: UCB0599 Low Dose Arm · No Placebo Group · Phase 2
UCB0599 Low Dose Arm
Drug
Experimental Group · 1 Intervention: UCB0599 · Intervention Types: DrugUCB0599 High Dose Arm
Drug
Experimental Group · 1 Intervention: UCB0599 · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
UCB0599
2019
Completed Phase 1
~40
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline to the safety follow-up visit (month 31)
Closest Location: Pd0055 50397 · Las Vegas, NV
N/AFirst Recorded Clinical Trial
1 TrialsResearching Parkinson's Disease (PD)
0 CompletedClinical Trials
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are capable of giving informed consent.
You are a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 1 month after the last dose of IMP
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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