A Randomized, Double-Blind, Placebo-controlled, 52-Week Phase II Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants with Early Parkinson’s Disease with A 11 Year All-Participants-on-Treatment Extension (PASADENA)

Conditions

Early Idiopathic Parkinson’s disease (PD)

Brief summary

1. Change in total MDS-UPDRS score (sum of Parts I, II and III) from baseline at Week 52.

Detailed description

1. Change from baseline in MDS-UPDRS Part IA, Part IB, Part I total, Part II total, Part III total and Part III subscores, 2. Change from baseline in Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) in ipsilateral (to the clinically dominant side) putamen, 3. Change from baseline in Montreal Cognitive Assessment (MoCA) total score, 4. Change from baseline in Clinical Global Impression (CGI-I), 5. Change from baseline in Patient Global Impression of change (PGIC), 6. Change from baseline in Schwab and England Activities of Daily Living (SE-ADL), 7. Time to worsening in motor or non-motor symptoms as measured in MDS-UPDRS, 8. Time to start of dopaminergic PD treatment (levodopa or dopamine-agonists), 9. Incidence and severity of adverse events (AEs) and serious AEs (SAEs), 10. Incidence of Anti-drug antibodies (ADAs), 11. Population and individual primary PK parameter estimations

Related papers

No related papers found yet.

Interventions

DRUGRO7046015

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Change in total MDS-UPDRS score (sum of Parts I, II and III) from baseline at Week 52.	—

Secondary

Measure	Time frame
1. Change from baseline in MDS-UPDRS Part IA, Part IB, Part I total, Part II total, Part III total and Part III subscores, 2. Change from baseline in Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) in ipsilateral (to the clinically dominant side) putamen, 3. Change from baseline in Montreal Cognitive Assessment (MoCA) total score, 4. Change from baseline in Clinical Global Impression (CGI-I), 5. Change from baseline in Patient Global Impression of change (PGIC), 6. Change from baseline in Schwab and England Activities of Daily Living (SE-ADL), 7. Time to worsening in motor or non-motor symptoms as measured in MDS-UPDRS, 8. Time to start of dopaminergic PD treatment (levodopa or dopamine-agonists), 9. Incidence and severity of adverse events (AEs) and serious AEs (SAEs), 10. Incidence of Anti-drug antibodies (ADAs), 11. Population and individual primary PK parameter estimations	—

Measure

Time frame

1. Change from baseline in MDS-UPDRS Part IA, Part IB, Part I total, Part II total, Part III total and Part III subscores, 2. Change from baseline in Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) in ipsilateral (to the clinically dominant side) putamen, 3. Change from baseline in Montreal Cognitive Assessment (MoCA) total score, 4. Change from baseline in Clinical Global Impression (CGI-I), 5. Change from baseline in Patient Global Impression of change (PGIC), 6. Change from baseline in Schwab and England Activities of Daily Living (SE-ADL), 7. Time to worsening in motor or non-motor symptoms as measured in MDS-UPDRS, 8. Time to start of dopaminergic PD treatment (levodopa or dopamine-agonists), 9. Incidence and severity of adverse events (AEs) and serious AEs (SAEs), 10. Incidence of Anti-drug antibodies (ADAs), 11. Population and individual primary PK parameter estimations

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Countries

Austria, France, Germany, Spain

Outcome results

None listed