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Minzasolmin for Parkinson's Disease

Phase 2
Waitlist Available
Research Sponsored by UCB Biopharma SRL
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to the safety follow-up visit (month 31)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug to see if it can help people with early onset Parkinson's disease.

Who is the study for?
This trial is for people with early-stage Parkinson's disease who completed a prior study (PD0053) and can start this one within 4 weeks of the last. Participants must agree to contraception use and not plan pregnancy or sperm donation during and after the trial. They should be able to consent and follow study rules.
What is being tested?
The trial tests long-term effects of Minzasolmin (UCB0599) on brain function in Parkinson's patients, comparing those who start treatment early versus those who begin later. It aims to understand how the drug influences disease progression over time.
What are the potential side effects?
While specific side effects are not listed here, participants will monitor for any adverse reactions related to Minzasolmin (UCB0599), which could include typical drug-related issues like nausea, dizziness, or other symptoms as observed in earlier trials.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to the safety follow-up visit (month 31)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to the safety follow-up visit (month 31) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Corpus striatum structure
Secondary study objectives
Cumulative Levodopa Equivalent Daily Dose; (LEDD) at PD0055 Month 18
Incidence of TEAEs leading to withdrawal from study
Incidence of serious adverse events (SAEs)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Minzasolmin (UCB0599) Low Dose ArmExperimental Treatment1 Intervention
Participants will receive a predefined low dosage of minzasolmin (UCB0599) during the Treatment Period.
Group II: Minzasolmin (UCB0599) High Dose ArmExperimental Treatment1 Intervention
Participants will receive a predefined high dosage of minzasolmin (UCB0599) during the Treatment Period.

Find a Location

Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor
115 Previous Clinical Trials
22,771 Total Patients Enrolled
UCB CaresStudy Director001 844 599 2273
219 Previous Clinical Trials
46,145 Total Patients Enrolled

Media Library

UCB0599 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05543252 — Phase 2
Parkinson's Disease Research Study Groups: Minzasolmin (UCB0599) High Dose Arm, Minzasolmin (UCB0599) Low Dose Arm
Parkinson's Disease Clinical Trial 2023: UCB0599 Highlights & Side Effects. Trial Name: NCT05543252 — Phase 2
UCB0599 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05543252 — Phase 2
~210 spots leftby Apr 2027
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