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

Conditions

Early Parkinson's disease

Brief summary

1. Time to confirmed motor progression event

Detailed description

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

Related papers

No related papers found yet.

Interventions

DRUGRO7046015 Placebo

DRUGRO7046015

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Time to confirmed motor progression event	—

Secondary

Measure	Time frame
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 adv	—

Measure

Time frame

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 adv

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Countries

Austria, France, Italy, Luxembourg, Poland, Spain

Outcome results

None listed