Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Parkinson Disease

Treatments: Drug: PF-06649751 middle dose 1 (3 mg QD); Drug: PF-06649751 high dose (15 mg QD); Drug: PF-06649751 middle dose 2 (7 mg QD); Drug: Placebo; Drug: PF-06649751 low dose (1 mg QD)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02687542

B7601003

A-ROSE PD (Other Identifier)

A-ROSE (Other Identifier)

2015-004912-39 (EudraCT Number)

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 who experience motor-fluctuations.

Full description

The study has a randomized, double-blind, placebo-controlled parallel group design. Approximately 198 subjects will be randomized to 5 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: 108 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females of non-childbearing potential and/or male subjects between the ages of 40 and 85 years, inclusive.
• Clinical diagnosis of Parkinson's disease.
• Able to refrain from any Parkinson's disease medication not permitted by the protocol.

Exclusion criteria

• Female of childbearing potential
• History or presence of atypical Parkinsonian syndrome.
• History of surgical intervention for Parkinson's disease.
• Severe acute or chronic medical or psychiatric condition 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.

Trial design

108 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

PF-06649751 low dose (1 mg QD)

Experimental group

Description:

PF-06649751 low dose level (1 mg QD)

Treatment:

Drug: PF-06649751 low dose (1 mg QD)

PF-06649751 middle dose 1 (3 mg QD)

Experimental group

Description:

PF-06649751 lower middle dose 1 (3 mg QD)

Treatment:

Drug: PF-06649751 middle dose 1 (3 mg QD)

PF-06649751 middle dose 2 (7 mg QD)

Experimental group

Description:

PF-06649751 higher middle dose 2 (7 mg QD)

Treatment:

Drug: PF-06649751 middle dose 2 (7 mg QD)

PF-06649751 high dose (15 mg QD)

Experimental group

Description:

PF-06649751 high dose (15 mg QD)

Treatment:

Drug: PF-06649751 high dose (15 mg QD)