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

Roche

Status and phase: Active, not recruiting; Phase 2

Conditions: Parkinsons Disease

Treatments: Drug: Placebo; Drug: Prasinezumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04777331

BN42358

2020-004997-23 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 586 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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586 participants in 2 patient groups, including a placebo group

Prasinezumab

Experimental group

Description:

Participants will receive an IV infusion of prasinezumab every 4 weeks (Q4W). Participants will enter into the optional Open Label Extension (OLE) once the double-blind treatment period has completed.

Treatment:

Drug: Prasinezumab

Placebo

Placebo Comparator group

Description:

Participants will receive placebo as an IV infusion Q4W.

Treatment:

Drug: Placebo