Parkinson's Disease
Conditions
Brief summary
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.
Interventions
DRUGPrasinezumab
Participants will receive Prasinezumab as an IV Infusion as per the schedule mentioned in the protocol.
DRUGPlacebo
Participants will receive Placebo as an IV Infusion per the schedule mentioned in the protocol
Sponsors
Hoffmann-La Roche
Prothena Biosciences Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Confirmed Motor Progression Event on Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score | Up to at least Week 104 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants With Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) | From Baseline up to 70 days after the final study dose (up to at least Week 104) |
| Serum Concentration of Prasinezumab | Predose and postdose at Baseline, Week 1, 4, 12, 24, 36, 52, 76, and after week 76 every 12 weeks thereafter until end of study (up to at least Week 104) |
| Change From Baseline in Motor Function as Measured by the MDS-UPDRS Part III off Medication Score | Baseline, Week 104 |
| Time to Worsening of Participants Motor Function as Reported by the Participant in the Presence of a Confirmed Motor Progression Event | Up to at least Week 104 |
| Time to Meaningful Worsening in Clinician Global Impression of Change (CGI-C), Overall Disease Subscale | Up to at least Week 104 |
| Time to increase in Levodopa Equivalent Daily Dose (LEDD) | Up to at least Week 104 |
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | From Baseline up to 70 days after the final study dose (up to at least Week 104) |
| Percentage of Participants With Adverse Events of Special Interest (AESI) | From Baseline up to 70 days after the final study dose (up to at least Week 104) |
| Percentage of Participants With Infusion Related Reactions (IRRs) | From Baseline up to 70 days after the final study dose (up to at least Week 104) |
| Percentage of Participants With ADAs Against Prasinezumab During the Study | From Baseline up to 70 days after the final study dose (up to at least Week 104) |
| Percentage of Participants With Anti-drug Antibodies (ADAs) Against Prasinezumab at Baseline | At Baseline |
Countries
Australia, Austria, Brazil, Canada, China, Denmark, France, Germany, Italy, Mexico, Poland, Portugal, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
CONTACTReference Study ID Number: BN44715 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed