A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early Parkinson's Disease

简要总结

主要结局

次要结局

• 1. Time-to-worsening of patient’s motor function as reported by the patient in MDS-UPDRS Part II and in the presence of a confirmed motor progression event
• 2. Time to meaningful worsening in Patient Global Impression of Change (PGI-C, Overall Disease Subscale)
• 3. Time to meaningful worsening in Clinician Global Impression of Change (CGI-C, Overall Disease Subscale)
• 4. Change in motor function from baseline to Week 76, as measured by the MDS-UPDRS Part III score
• 5. Change in bradykinesia and rigidity from baseline to Week 76, as measured by the MDS-UPDRS Part III bradykinesia and rigidity subscore
• 6. Time to onset of motor complications as assessed through MDS-UPDRS Part IV
• 7. Nature, Incidence, seriousness and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
• 8. Incidence of adverse events of special interest
• 9. Incidence of treatment discontinuation due to adverse events
• 10. Nature, Incidence, seriousness and severity of infusion-related reactions (IRRs)
• 11. Change from baseline in vital signs
• 12. Incidence of abnormal vital sign measurements
• 13. Change from baseline in electrocardiogram (ECG) assessments
• 14. Incidence of abnormal ECG assessments
• 15. Change from baseline in laboratory measurements
• 16. Incidence of abnormal laboratory measurements
• 17. Incidence of physical and neurologic examination abnormalities
• 18. Change from baseline in suicidal ideation, as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
• 19. Serum concentration of prasinezumab at specified timepoints
• 20. Prevalence of anti-drug antibodies (ADAs) against prasinezumab at baseline
• 21. Incidence of ADAs against prasinezumab during the study