Minzasolmin for Parkinson's Disease

Recruiting in Palo Alto (17 mi)

+96 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: UCB Biopharma SRL

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of the study is to estimate the pharmacodynamic effects of minzasolmin (UCB0599) on brain pathophysiology in Early-start versus Delayed-start participants originally diagnosed with new onset Parkinson's disease.

Eligibility Criteria

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.

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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

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Treatment Details

Interventions

UCB0599 (Other)

Trial OverviewThe 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.

Participant Groups

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.