IRB Study Number 25-927
Status Recruiting
Phase Phase 3
Location Cleveland Clinic Main Campus
Institute Neurological Institute
Description
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) or prasinezumab compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa/
The study is divided into three main parts and will last ≥ 28 months.
- Screening: doctors will check if you're a good fit for the study and the study is a good fit for you.
- Treatment (≥ 2 years): you will receive either prasinezumab or placebo (while continuing your levodopa) and have monthly clinic visits that will take about 4-6 hours.
- Follow-up (up to 2.5 months): doctors will continue to monitor your health after treatment.
There is a chance to take part in an additional 2-year extension where everyone will receive the active drug prasinezumab (no placebo).
Inclusion Criteria
- 50-85 years of age
- Body weight within 88-242 lbs (40-110 kgs) and BMI within 18-34 kg/m2
- Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria for at least 3 months but no more than 3 years
- Taking levodopa to help with symptoms
- MDS-UPDRS Part IV score of 0 at screening and prior to randomization
- Hoehn & Yahr (H&Y) Stage 1 or 2 off medication at screening and prior to randomization
- Agreement to adhere to contraception requirements
Exclusion Criteria
- Pregnant or breastfeeding, or intention of becoming pregnant during study or within time frame in which contraception is required
- Medical history indicating parkinsonian syndrome other than idiopathic PD
- Diagnosis of significant neurologic disease other than PD
- Chronic uncontrolled hypertension
