Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease

Pfizer

Status and phase

Terminated

Phase 2

Conditions

Parkinson Disease

Treatments

Drug: PF-06649751

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02847650

2016-001575-71 (EudraCT Number)

B7601011

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751 in Parkinson's disease patients at early stage of the disease.

Full description

The B7601011 study has a randomized, double-blind, placebo-controlled parallel group design. Approximately 88 subjects will be randomized to 2 treatment groups. Each subject will participate in the study for approximately 23 weeks including a 30 day screening period, 15 week double blind treatment period, and an approximately 28 day follow-up period.

Enrollment

57 patients

Sex

All

Ages

45 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Females of non-childbearing potential and/or male subjects
Clinical diagnosis of Parkinson's disease.
Parkinson's Disease Hoehn & Yahr Stage I-III inclusive
Treatment naïve or history of prior incidental treatment with dopaminergic agents for no more than 28 days
Able to refrain from any Parkinson's disease medication not permitted by the protocol.

Exclusion criteria

History or presence of atypical Parkinsonian syndrome.
Severe acute or chronic medical or psychiatric condition or cognitive impairment or laboratory abnormality.
Any condition possibly affecting drug absorption.
Participation in other studies involving investigational drug(s), or treatment with any investigational drug within 30 days.