Studies for Parkinson's Disease Patients Not Receiving Any Treatment

A Study to Evaluate the Efficacy of RO7046015 in Participants With Early Parkinson's Disease

Brief Summary: This multicenter, randomized, double-blind, placebo-controlled, Phase 2 study will evaluate the efficacy of intravenous RO7046015 versus placebo over 52 weeks in participants with early Parkinson's Disease (PD) who are untreated or treated with monoamine oxidase B (MAO-B) inhibitors since baseline. The study will consist of 2 parts: a 52-week, double-blind, placebo-controlled treatment period (Part 1) after which eligible participants will continue into an all-participants-on-treatment blinded dose extension for an additional 52 weeks (Part 2).

Duration: Part 1 - 52 weeks, Part 2 - 52 weeks

Study design: Randomized, double-blind, placebo-controlled

Inclusion Criteria:
40-80 years of age
Body mass index (BMI) of 18 to 34 kilograms per meter-squared (kg/m^2)
A diagnosis of PD for 2 years or less at screening
Clinical status does not require dopaminergic PD medication and is not expected to require dopaminergic treatment within 52 weeks from baseline
If presently being treated for PD, a stable dose of MAO-B inhibitor (rasagiline or selegiline) for at least 90 days prior to baseline and not expected to change within 52 weeks

Exclusion Criteria:
A diagnosis of a significant CNS disease other than Parkinson's disease; history of repeated head injury; history of epilepsy or seizure disorder other than febrile seizures as a child
Reside in a nursing home or assisted care facility
Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study
Any significant cardiovascular condition
Any significant laboratory abnormality
Anti-epileptic medication for non-seizure-related treatment which has not remained stable for at least 60 days prior to baseline
Anti-depressant or anxiolytic use that has not remained stable for at least 90 days prior to baseline
Any prior treatment with an investigational PD-related vaccine
Any contraindications to obtaining a brain MRI
Donation of blood over 500 milliliters (mL) within three months prior to screening

 

For people taking no Parkinson's Disease Medications

A Phase 3 Study With P2B001 in Subjects With Early Parkinson's

Brief Summary: A Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson's Disease and to a Calibration Arm of Pramipexole ER.

Study Design: Randomized, Double-Blind, Double-Dummy

Inclusion Criteria:
35 Years to 75 Years
Subject has Parkinson's disease
Subject with disease duration less than 3 years.

Exclusion Criteria:
Subject has an atypical parkinsonian syndrome or secondary parkinsonism.
Subject has previous exposure to levodopa or a dopamine agonist for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 2 months prior to the baseline visit.
Subject has previous exposure to a MAO-B inhibitor for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 3 months prior to the baseline visit.
Subject who has taken anticholinergic drugs for PD or amantadine for longer than 4 weeks; if previous exposure was less than 4 weeks then it must not be within 1 month prior to the baseline visit.

Last modified: Apr 01, 2018
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