UCB0599 Low Dose Arm for Parkinson's Disease (PD)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Pd0055 50397, Las Vegas, NV
Parkinson's Disease (PD)+1 More
UCB0599 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

1 of 3

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

2 of 3
This is further along than 68% of similar trials

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: Drug
UCB0599 High Dose Arm
Drug
Experimental Group · 1 Intervention: UCB0599 · Intervention Types: Drug
Treatment
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
Photo of las vegas  1Photo of las vegas  2Photo of las vegas  3
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 preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

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.