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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50-85
SponsorHoffmann-La Roche

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Prasinezumab
  • Placebo

Treatment groups

900 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hoffmann-La Roche

Lead sponsor

Prothena Biosciences Limited

Collaborator