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

  • STATUS
    Recruiting
  • End date
    Sep 18, 2026
  • participants needed
    575
  • sponsor
    Hoffmann-La Roche
Updated on 28 October 2022
dopamine
SPECT Scan
dopamine transporter
parkinsonism
tremor
bradykinesia
resting tremor
early parkinson's

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.

Description


Details
Condition Parkinsons Disease
Treatment Placebo, Prasinezumab
Clinical Study IdentifierNCT04777331
SponsorHoffmann-La Roche
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

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, with stable doses for at least 3 months prior to baseline
A diagnosis of PD for at least 3 months to maximum 3 years at screening
MDS-UPDRS Part IV score of 0 at screening and prior to randomization
Hoehn and Yahr (H&Y) Stage I or II in OFF medication state at screening and prior to randomization
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 neurologic disease other than PD
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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