Minzasolmin for Parkinson's Disease

No longer recruiting at 109 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: UCB Biopharma SRL
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called minzasolmin (also known as UCB0599) to observe its effects on the brain in individuals with newly diagnosed Parkinson's disease. Researchers aim to understand the differences between starting the medication immediately versus delaying it. Participants will receive either a high or low dose of minzasolmin. This trial is for individuals who have already completed a prior study with the same medication. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that minzasolmin (UCB0599) is generally safe and well-tolerated. In one study, 94 participants, including both healthy individuals and those with Parkinson's disease, received different doses of minzasolmin. The results indicated that most participants handled the treatment well. No major safety issues arose, and the side effects were expected and manageable. These findings are promising for those considering joining a clinical trial for minzasolmin. However, consulting a healthcare professional is always important if there are questions about participating in a clinical trial.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about minzasolmin (UCB0599) because it targets a new pathway in Parkinson's disease treatment. Most current treatments, like levodopa, focus on replacing dopamine or managing symptoms. However, minzasolmin aims to slow disease progression by inhibiting alpha-synuclein aggregation, a protein linked to the condition's underlying cause. This approach could potentially modify the disease itself, not just alleviate symptoms. The trial is testing both high and low doses to find the most effective treatment option.

What evidence suggests that minzasolmin could be an effective treatment for Parkinson's disease?

Research has shown that minzasolmin (UCB0599) is under study as a potential treatment for Parkinson's disease. It targets a protein called alpha-synuclein, linked to the disease. The treatment aims to slow Parkinson’s progression by preventing this protein from misfolding. Earlier studies suggested that minzasolmin might help reduce issues with alpha-synuclein, potentially protecting brain function. However, the major study ORCHESTRA did not meet its primary goals and showed no clear effect on Parkinson's symptoms. Despite these mixed results, research continues to explore minzasolmin's potential benefits. Participants in this trial will receive either a high or low dose of minzasolmin (UCB0599) to further investigate its effects.23678

Who Is on the Research Team?

UC

UCB Cares

Principal Investigator

001 844 599 2273

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Participant completed the Treatment Period of PD0053 (NCT04658186) with the Baseline Visit for PD0055 (Visit 2) no later than 4 weeks following the end of treatment (EOT) Visit in PD0053 (NCT04658186), with any delay justified by the Investigator and approved by the Sponsor
I am not pregnant or breastfeeding and agree to use contraception during and for 1 month after treatment.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent form (ICF) and in this protocol.
See 1 more

Exclusion Criteria

Study participants wearing any kind of implantable active device will be excluded from using Digital Health Technology but may participate in the main study
Study participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or compromise the study participant's ability to participate
Study participant had previously participated in PD0055
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a high or low dose of minzasolmin (UCB0599) to evaluate its long-term efficacy, safety, and tolerability

18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

13 months

Open-label extension

Participants may continue to receive the study drug to further assess long-term effects

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • UCB0599
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Minzasolmin (UCB0599) Low Dose ArmExperimental Treatment1 Intervention
Group II: Minzasolmin (UCB0599) High Dose ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

UCB Biopharma SRL

Lead Sponsor

Trials
118
Recruited
23,200+

Jean-Christophe Tellier

UCB Biopharma SRL

Chief Executive Officer since 2015

MD from University of Reims Champagne-Ardenne, Rheumatology specialization from University of Paris V, Executive business programs at Harvard and INSEAD

Dr. Iris Loew-Friedrich

UCB Biopharma SRL

Chief Medical Officer since 2014

MD from University of Leuven, PhD in Medical Sciences from University of Leuven

Citations

In vivo effects of the alpha-synuclein misfolding inhibitor ...Taken together, the current results demonstrate that treatment with the ASYN misfolding inhibitor minzasolmin reduces ASYN pathology, restores ...
Findings from minzasolmin proof-of-concept ORCHESTRA ...UCB announces ORCHESTRA1 minzasolmin study did not meet primary or secondary clinical endpoints; UCB reinforces commitment to Parkinson's research, ...
NCT05543252 | An Extension Study to Evaluate the Long- ...The purpose of the study is to estimate the pharmacodynamic effects of minzasolmin (UCB0599) on brain pathophysiology in Early-start versus Delayed-start ...
Phase 1/1b Studies of UCB0599, an Oral Inhibitor of α‐ ...UCB0599, an oral small‐molecule inhibitor of alpha‐synuclein misfolding, aims to slow Parkinson's disease (PD) progression.
News in Context: Mixed Results from Two Experimental ...The UCB–Novartis ORCHESTRA trial of minzasolmin (UCB0599) found the drug had no effect on Parkinson's, and the companies do not plan to continue ...
NCT05543252 | An Extension Study to Evaluate the Long- ...The purpose of the study is to estimate the pharmacodynamic effects of minzasolmin (UCB0599) on brain pathophysiology in Early-start versus Delayed-start ...
7.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/35959805/
Phase 1/1b Studies of UCB0599, an Oral Inhibitor of α- ...Seventy-three HPs and 21 participants with PD received UCB0599 doses; an acceptable safety/tolerability profile and predictable PK support ...
Clinical Trial UpdatesThe purpose of the study is to assess the safety and tolerability of UCB0599 and to demonstrate the superiority of UCB0599 over placebo with regard to ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security