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

NCT07174310
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
900
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Lead sponsor
Hoffmann-La Roche
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Start date
2025-11-24
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Number of sites
192
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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.
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Acronym
PARAISO
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Short title
A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease
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Official title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants With Early-Stage Parkinson's Disease
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2031-06-30
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First posted
2025-09-15
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Registry last updated
2026-10-06
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Primary completion date
2029-06-30
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Start date
2025-11-24
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Participants
900
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Participant count basis
Estimated
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Planned participants
900
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Protocol amendments
0
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Number of sites
192
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Hoffmann-La Roche
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07174310
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ClinicalTrials.gov ID
NCT07174310
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Triple masking
Masked roles
Participants, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Time to Confirmed Motor Progression Event on Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score

    Timeframe: Up to at least Week 104

  1. Change From Baseline in Motor Function as Measured by the MDS-UPDRS Part III off Medication Score

    Timeframe: Baseline, Week 104

  2. Time to Worsening of Participants Motor Function as Reported by the Participant in the Presence of a Confirmed Motor Progression Event

    Timeframe: Up to at least Week 104

  3. Time to Meaningful Worsening in Clinician Global Impression of Change (CGI-C), Overall Disease Subscale

    Timeframe: Up to at least Week 104

  4. Time to increase in Levodopa Equivalent Daily Dose (LEDD)

    Timeframe: Up to at least Week 104

  5. Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)

    Timeframe: From Baseline up to 70 days after the final study dose (up to at least Week 104)

  6. Percentage of Participants With Adverse Events of Special Interest (AESI)

    Timeframe: From Baseline up to 70 days after the final study dose (up to at least Week 104)

  7. Percentage of Participants With Infusion Related Reactions (IRRs)

    Timeframe: From Baseline up to 70 days after the final study dose (up to at least Week 104)

  8. Percentage of Participants With Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)

    Timeframe: From Baseline up to 70 days after the final study dose (up to at least Week 104)

  9. Serum Concentration of Prasinezumab

    Timeframe: 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)

  10. Percentage of Participants With Anti-drug Antibodies (ADAs) Against Prasinezumab at Baseline

    Timeframe: At Baseline

  11. Percentage of Participants With ADAs Against Prasinezumab During the Study

    Timeframe: From Baseline up to 70 days after the final study dose (up to at least Week 104)

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
50 Years
Maximum age
85 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
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  • University of Alabama at BirminghamBirmingham, United StatesRecruiting
  • Barrow Neurological InstitutePhoenix, United StatesRecruiting
  • Neurology Center of North Orange CountyFullerton, United StatesRecruiting
  • UC San DiegoLa Jolla, United StatesRecruiting
  • Keck School of Medicine of USCLos Angeles, United StatesRecruiting
  • UCLA Neurology Outpatient ClinicLos Angeles, United StatesRecruiting
  • Parkinson?s Research Centers of America ? Palo AltoPalo Alto, United StatesRecruiting
  • Profound Research LLC at The Neurology Center of Southern CaliforniaPasadena, United StatesRecruiting
  • UCSF Weill Institute for NeurosciencesSan Francisco, United StatesRecruiting
  • Stanford Neuroscience Health Center (SNHC)Stanford, United StatesRecruiting
  • Rocky Mountain Movement DisordersEnglewood, United StatesRecruiting
  • Institute for Neurodegenerative DisordersNew Haven, United StatesRecruiting
  • Georgetown UniversityWashington D.C., United StatesRecruiting
  • JEM Research LLCAtlantis, United StatesRecruiting
  • Parkinson's Disease and Movement Disorders Center of Boca RatonBoca Raton, United StatesRecruiting
  • K2 - VillagesLady Lake, United StatesRecruiting
  • K2 Medical Research-MaitlandMaitland, United StatesRecruiting
  • Baptist Hospital of MiamiMiami, United StatesRecruiting
  • Charter Research - Winter Park/OrlandoOrlando, United StatesRecruiting
  • Advent Health OrlandoOrlando, United StatesRecruiting
  • USF Parkinsons Disease and Movement Disorders CenterTampa, United StatesRecruiting
  • Grady Memorial HospitalAtlanta, United StatesRecruiting
  • Hawaii Pacific NeuroscienceHonolulu, United StatesRecruiting
  • Northwestern University Feinberg School Of MedicineChicago, United StatesRecruiting
  • University of Kansas Medical CenterKansas City, United StatesRecruiting

And 167 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-522683-32-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Conditions (1)

Targets (1)