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

Study acronym: PARAISO
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 1 entry Eligibility criteria expanded, about 10 words · Site details revised at 7 of 192 sites · Publications: details revised at 1 of 1 entry Show 3 more changesShow less
    • Eligibility criteria expanded, about 10 words
    • Site details revised at 7 of 192 sites
    • Publications: details revised at 1 of 1 entry
  2. Trial sites expanded: 184 → 192 locationsv14
  3. Trial sites expanded: 174 → 184 locationsv13
  4. Trial sites expanded: 160 → 174 locationsv12
  5. Trial sites expanded: 142 → 160 locationsv11
  6. Trial sites expanded: 101 → 142 locationsv10
  7. Trial sites expanded: 66 → 101 locationsv9
  8. Study sites: 38 to 66v8
  9. Study sites: 24 to 38v7
  10. Study sites: 10 to 24v6
  11. Study sites: 6 to 10 Primary completion date: Jul 27, 2029 to Jun 30, 2029 · Completion date: Jul 25, 2031 to Jun 30, 2031 · Start date changed from estimate of Dec 31, 2025 to Nov 24, 2025v5 Show 3 more changesShow less
    • Primary completion date: Jul 27, 2029 to Jun 30, 2029
    • Completion date: Jul 25, 2031 to Jun 30, 2031
    • Start date changed from estimate of Dec 31, 2025 to Nov 24, 2025
  12. Study sites: 2 to 6v4
  13. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2v3 Show 1 more changeShow less
    • Study sites: 0 to 2
  14. Re-verified, no change to tracked fieldsv2
  15. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT07174310
Lead Sponsor Hoffmann-La Roche
Collaborators: Prothena Biosciences Limited
Conditions Parkinson's Disease
Enrollment 900 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov