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

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ClinicalTrials.gov Identifier: NCT04777331
Recruitment Status : Recruiting
First Posted : March 2, 2021
Last Update Posted : May 19, 2021
Sponsor:
Collaborator:
Prothena Biosciences Limited
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This is a multicenter, randomized, double-blind, placebo-controlled study that will evaluate the efficacy and safety of intravenous (IV) prasinezumab versus placebo in participants with Early Parkinson's Disease (PD) who are on stable symptomatic PD medication.

Condition or disease Intervention/treatment Phase
Parkinsons Disease Drug: Prasinezumab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 575 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 5, 2021
Estimated Primary Completion Date : November 13, 2023
Estimated Study Completion Date : January 22, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prasinezumab
Participants will receive an IV infusion of prasinezumab every 4 weeks (Q4W).
Drug: Prasinezumab
Prasinezumab will be administered as an IV infusion to participants Q4W.

Placebo Comparator: Placebo
Participants will receive placebo as an IV infusion Q4W.
Drug: Placebo
Prasinezumab placebo will be administered to participants.




Primary Outcome Measures :
  1. Time to Meaningful Progression on Motor Signs of the Disease, as Assessed by >= 5 Points Increase in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score from Baseline [ Time Frame: From baseline until 28 days after final dose of study treatment ]

Secondary Outcome Measures :
  1. Time-to-worsening of Participants Motor Function as Reported by the Participant in MDS-UPDRS Part II and Confirmed by the Clinician in MDS-UPDRS Part III [ Time Frame: From baseline until 28 days after final dose of study treatment ]
  2. Time to Meaningful Worsening in Patient Global Impression of Change (PGI-C, Overall Disease Subscale) [ Time Frame: From baseline until 28 days after final dose of study treatment ]
  3. Time to Meanaingful Worsening in Clinician Global Impression of Change (CGI-C, Overall Disease Subscale) [ Time Frame: From baseline until 28 days after final dose of study treatment ]
  4. Change in Motor Function from Baseline to Week 76, as Measured by the MDS-UPDRS Part III Total Score [ Time Frame: From baseline to Week 76 ]
  5. Change in Bradykinesia from Baseline to Week 76, as Measured by the MDS-UPDRS Part III Bradykinesia Subscore [ Time Frame: From baseline to Week 76 ]
  6. Change in Motor Aspects of Experiences of Daily Living from Baseline to Week 76, as Measured by MDS-UPDRS Part II [ Time Frame: From baseline to Week 76 ]
  7. Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: From baseline until 70 days after final dose of study treatment ]
  8. Number of Participants with Adverse Events of Special Interest (AESI) [ Time Frame: From baseline until 70 days after final dose of study treatment ]
  9. Number of Participants with Infusion Related Reactions (IRRs) [ Time Frame: From baseline until 70 days after final dose of study treatment ]
  10. Change from Baseline in Suicidal Ideation, as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: From baseline until 28 days after final dose of study treatment ]
  11. Serum Concentration of Prasinezumab [ Time Frame: From weeks 1, 2, 4, 8, 12, 24, 36, 52, 64, 76 and after week 76 every 12 weeks therafter until end of study (approximately 28 days after the final dose) ]
  12. Percentage of Participants with Anti-drug Antibodies (ADAs) Against Prasinezumab at Baseline [ Time Frame: At Baseline ]
  13. Percentage of Participants with ADAs Against Prasinezumab During the Study [ Time Frame: Up to end of study visit (approximately 76 weeks) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of idiopathic PD based on MDS criteria with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism
  • On symptomatic PD medication for at least 6 months, with stable doses for 3 months prior to baseline
  • A diagnosis of PD for at least 6 months to maximum 3 years at screening
  • MDS-UPDRS Part IV score= 0
  • Hoehn and Yahr (H&Y) Stage I or II in ON and OFF states
  • Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) imaging consistent with dopamine transporter deficit, as assessed by the central reader
  • No anticipated changes in PD medication from baseline throughout the study duration based on clinical status during screening
  • Willingness and ability to use a smartphone application to measure PD-related symptoms for the duration of the study
  • Willingness and ability to wear a smartwatch to measure PD-related motor signs

Exclusion Criteria:

  • Medical history indicating a Parkinsonian syndrome other than idiopathic PD
  • Diagnosis of PD dementia
  • Diagnosis of a significant central nervous system (CNS) disease other than Parkinson's disease
  • Within the last year, unstable or clinically significant cardiovascular disease
  • Uncontrolled hypertension
  • Drug and/or alcohol abuse within 12 months prior to screening, in the investigator's judgment (Nicotine is allowed, Marijuana use is not allowed)
  • Clinically significant abnormalities in laboratory test results at the screening visit, including hepatic and renal panels, complete blood count, chemistry panel and urinalysis
  • Allergy to any of the components of prasinezumab, a known hypersensitivity, or a previous IRR following administration of any other monoclonal antibody
  • Any contraindications to obtaining a brain magnetic resonance imaging (MRI)
  • Any contraindications to DaT-SPECT imaging

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04777331


Contacts
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Contact: Reference Study ID Number: BN42358 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Prothena Biosciences Limited
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04777331    
Other Study ID Numbers: BN42358
2020-004997-23 ( EudraCT Number )
First Posted: March 2, 2021    Key Record Dates
Last Update Posted: May 19, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases