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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to the safety follow-up visit (month 31)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Corpus striatum structure

Secondary outcome measures

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

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

UCB Biopharma SRLLead Sponsor

101 Previous Clinical Trials

21,062 Total Patients Enrolled

UCB CaresStudy Director001 844 599 2273

205 Previous Clinical Trials

44,589 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please tell us about the safety profile of UCB0599?

"UCB0599 was given a score of 2 by our Power team. This is because, while there are Phase 2 trials supporting its safety, none have been done to explore if it is an effective medication."

Answered by AI

What are the objectives of this experiment?

"The primary objective of this study, as seen in the DaT-SPECT whole striatum SBR at PD0055 Month 18 data, is to compare the efficacy of two different dosages of investigational medication. Additionally, this clinical trial will be measuring if there are any adverse effects associated with treatment and changes in daily levodopa equivalent dose."

Answered by AI

Are young adults within the age limit of this experiment?

"The age limit for participants in this clinical trial is 78 years old. All patients that are above the age of 40 are eligible to enroll."

Answered by AI

Are there any remaining vacancies in this clinical trial?

"The clinicaltrial.gov website says this 517 other medical trials are presently looking for patients at this time."

Answered by AI

Who meets the eligibility requirements for this clinical trial?

"This clinical trial is looking for 270 patients with parkinson's disease (PD) between the ages of 40 and 78. To be eligible, participants must have completed the Treatment Period of PD0053 (NCT04658186), and their Baseline Visit for PD0055 (Visit 2) needs to be within 4 weeks following the end of treatment (EOT) Visit in PD0053 (NCT04658186). In addition, male study participants must agree to use contraception during the Treatment Period and for at least 90 days after the last dose of investigational medicinal product (IMP), and refrain from donating sperm during"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Extension Study to Evaluate the Long-Term Efficacy, Safety and Tolerability of Minzasolmin (UCB0599) in Study Participants With Parkinson's Disease

2022. "An Extension Study to Evaluate the Long-Term Efficacy, Safety and Tolerability of Minzasolmin (UCB0599) in Study Participants With Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05543252.