IV prasinezumab treatment for people with early-stage Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, randomized, placebo-controlled trial testing intravenous prasinezumab compared with placebo in participants with early-stage idiopathic Parkinson's disease. Adults must be on stable symptomatic monotherapy with levodopa, meet Hoehn and Yahr stage 1–2 off medication, and have an MDS-UPDRS Part IV score of 0 at screening. The study will collect efficacy, safety, and pharmacokinetic (PK) data over the treatment and follow-up periods. Key exclusions include non-idiopathic parkinsonian syndromes, other significant neurologic diseases, pregnancy/breastfeeding, and uncontrolled chronic hypertension.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Body weight within 40-110 kilograms (kg) (88-242 pounds \[lbs\]) and a body mass index within the range 18-34 kg/m2
* Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria
* Has received monotherapy treatment
* An MDS-UPDRS Part IV score of 0 at screening and prior to randomization
* Hoehn and Yahr (H\&Y) Stage 1 or 2 off medication at screening and prior to randomization
* Agreement to adhere to the contraception requirements

Exclusion Criteria:

* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required
* Medical history indicating a parkinsonian syndrome other than idiopathic PD
* Diagnosis of a significant neurologic disease other than PD
* Chronic uncontrolled hypertension

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• Barrow Neurological Institute
  Phoenix, Arizona, United States Recruiting
• Neurology Center of North Orange County
  Fullerton, California, United States Recruiting
• UC San Diego
  La Jolla, California, United States Recruiting
• Keck School of Medicine of USC
  Los Angeles, California, United States Recruiting
• UCLA Neurology Outpatient Clinic
  Los Angeles, California, United States Recruiting

+142 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Reference Study ID Number: BN44715 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. and Canada)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.