UCB0599 for Parkinson Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Parkinson Disease+1 More
UCB0599 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new medication for Parkinson's Disease to see if it is safe and better than the placebo at reducing symptoms over 12 to 18 months.

Eligible Conditions
  • Parkinson Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: From Baseline up to 19 Months

Month 18
MDS-UPDRS Part I subscale
MDS-UPDRS Part II subscale
MDS-UPDRS Part III subscale
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-III sum score
Symptomatic treatment intake
Time to start of symptomatic treatment (ST)
Time to worsening of the disease on MDS-UPDRS Part III scale
Month 19
Incidence of TEAEs leading to participant withdrawal
Incidence of treatment-emergent adverse events (TEAEs)
Month 18
Change in Dopamine Transporter Imaging with Single Photon Emission Computed Tomography (DaT-SPECT) mean striatum specific binding ratios (SBR)
Change in Montreal Cognitive Assessment (MoCA)
Montreal Cognitive Assessment (MoCA)
Month 19
Incidence of serious adverse events (SAEs)

Trial Safety

Safety Progress

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

Trial Design

4 Treatment Groups

UCB0599 Arm
1 of 4
UCB0599 High Dose Arm
1 of 4
UCB0599 Low Dose Arm
1 of 4
Placebo Arm
1 of 4
Experimental Treatment
Non-Treatment Group

450 Total Participants · 4 Treatment Groups

Primary Treatment: UCB0599 · Has Placebo Group · Phase 2

UCB0599 Arm
Drug
Experimental Group · 1 Intervention: UCB0599 · Intervention Types: Drug
UCB0599 High Dose Arm
Drug
Experimental Group · 1 Intervention: UCB0599 · Intervention Types: Drug
UCB0599 Low Dose Arm
Drug
Experimental Group · 1 Intervention: UCB0599 · Intervention Types: Drug
Placebo Arm
Drug
PlaceboComparator Group · 1 Intervention: Placebo · 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 up to 19 months

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
82 Previous Clinical Trials
20,214 Total Patients Enrolled
4 Trials studying Parkinson Disease
2,418 Patients Enrolled for Parkinson Disease
UCB CaresStudy Director001 844 599 2273
184 Previous Clinical Trials
42,588 Total Patients Enrolled
5 Trials studying Parkinson Disease
489 Patients Enrolled for Parkinson Disease

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are in the ≤2.5 Hoehn and Yahr stage at Screening.
You are 40 to 75 years of age inclusive.
You have Parkinson's Disease (PD), with a diagnosis made by a neurologist within 2 years of Baseline Visit.
You have bradykinesia AND at least ONE of the following: muscular rigidity, or resting tremor AND you have evidence of dopamine transporter deficit per study requirements and as determined by a central reader.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 13th, 2021

Last Reviewed: October 7th, 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.