IV Prasinezumab for Early-Stage Parkinson's Disease

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Recruiting Phase 3 Interventional Study
Parkinson's Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
50 – 85
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
900 (estimated)
Sponsor
Hoffmann-La Roche · Industry
Who this trial is looking for

This trial is looking for people with early-stage Parkinson's disease who are currently on stable treatment with levodopa. Participants will receive either the drug prasinezumab or a placebo to study its effects.

Are You a Good Fit for This Trial?
Must be taking Levodopa

You may be able to join if

  • I weigh between 88 and 242 pounds.
  • I have been diagnosed with Parkinson's disease.
  • I am currently receiving monotherapy treatment.
  • I have a score of 0 on the MDS-UPDRS Part IV.
  • I am in Hoehn and Yahr Stage 1 or 2.
  • I agree to follow the contraception requirements.

You may not be able to join if

  • I am pregnant or breastfeeding.
  • I plan to become pregnant during the study.
  • I have a Parkinson's syndrome other than idiopathic Parkinson's disease.
  • I have a significant neurologic disease other than Parkinson's disease.
  • I have chronic uncontrolled hypertension.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.

Trial Locations
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Eligibility Criteria
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 screenin…
Contacts

Reference Study ID Number: BN44715 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. and Canada)

global-roche-genentech-trials@gene.com

CONTACT

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT