MedDataX Logo

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

NCT ID: NCT02687542

Last Updated: 2020-11-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-03

Study Completion Date

2017-11-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Parkinson Disease Motor Fluctuation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

PF-06649751 low dose (1 mg QD)

PF-06649751 low dose level (1 mg QD)

Group Type EXPERIMENTAL

PF-06649751 low dose (1 mg QD)

Intervention Type DRUG

PF-06649751 low dose (1 mg QD)

PF-06649751 middle dose 1 (3 mg QD)

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

Group Type EXPERIMENTAL

PF-06649751 middle dose 1 (3 mg QD)

Intervention Type DRUG

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

PF-06649751 middle dose 2 (7 mg QD)

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

Group Type EXPERIMENTAL

PF-06649751 middle dose 2 (7 mg QD)

Intervention Type DRUG

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

PF-06649751 high dose (15 mg QD)

PF-06649751 high dose (15 mg QD)

Group Type EXPERIMENTAL

PF-06649751 high dose (15 mg QD)

Intervention Type DRUG

PF-06649751 high dose (15 mg QD)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Placebo

Intervention Type DRUG

PF-06649751 low dose (1 mg QD)

PF-06649751 low dose (1 mg QD)

Intervention Type DRUG

PF-06649751 middle dose 1 (3 mg QD)

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

Intervention Type DRUG

PF-06649751 middle dose 2 (7 mg QD)

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

Intervention Type DRUG

PF-06649751 high dose (15 mg QD)

PF-06649751 high dose (15 mg QD)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Xenoscience, Inc

Phoenix, Arizona, United States

Site Status

St Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Site Status

Arcadia Neurology Center

Arcadia, California, United States

Site Status

Faculty Physicians and Surgeons of Loma Linda University School of Medicine

Loma Linda, California, United States

Site Status

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Site Status

Hoag Memorial Hospital

Newport Beach, California, United States

Site Status

SC3 Research Group, Inc

Pasadena, California, United States

Site Status

Neurosearch-Torrance

Torrance, California, United States

Site Status

Associated Neurologists of Southern Connecticut, PC

Fairfield, Connecticut, United States

Site Status

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

Site Status

University of Florida Center for Movement Disorders and Neurorestoration

Gainesville, Florida, United States

Site Status

Neurology Associates of Ormond Beach

Ormond Beach, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Vero Beach Neurology and Research Institute

Vero Beach, Florida, United States

Site Status

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Indiana University Health Neuroscience Center

Indianapolis, Indiana, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

CRI Worldwide, LLC

Marlton, New Jersey, United States

Site Status

Dent Neurologic Institute

Amherst, New York, United States

Site Status

Dent Neurosciences Research Center ,Inc. DBA Dent Neurologic Institute

Amherst, New York, United States

Site Status

Dent Neurologic Institute

Orchard Park, New York, United States

Site Status

Duke University Medical center

Durham, North Carolina, United States

Site Status

Duke University/Duke Neurology/Department of Neurology

Durham, North Carolina, United States

Site Status

Wake Research Associates, LLC

Raleigh, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

University of Toledo

Toledo, Ohio, United States

Site Status

The Movement Disorder Clinic of Oklahoma

Tulsa, Oklahoma, United States

Site Status

Abington Neurological Associates, Ltd.

Willow Grove, Pennsylvania, United States

Site Status

Rhode Island Hospital/ Brown University Medical School

Providence, Rhode Island, United States

Site Status

AS Clinical Research Consultants of North Texas, PLLC

Greenville, Texas, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

Booth Gardner Parkinson's Care Center

Kirkland, Washington, United States

Site Status

Montreal Neurological Hospital Research Pharmacy

Montreal, Quebec, Canada

Site Status

Montreal Neurological Institute and Hospital

Montreal, Quebec, Canada

Site Status

CHU de Grenoble Alpes

Grenoble, , France

Site Status

CHU de Grenoble Alpes

La Tronche, , France

Site Status

CHRU de Lille-Hopital Roger Salengro

Lille, , France

Site Status

Hopital de la Timone APHM

Marseille, , France

Site Status

Hopital de La Timone

Marseille, , France

Site Status

Hopital La Pitie-Salpetriere

Paris, , France

Site Status

Universitaetsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

St. Josef-Hospital GmbH

Bochum, , Germany

Site Status

Universitaetsklinikum Carl Gustav Carus Klinik und Poliklinik fur Neurologie

Dresden, , Germany

Site Status

Klinikum rechts der Isar der Technischen Universitaet Muenchen

München, , Germany

Site Status

Universitaetsklinik Ulm

Ulm, , Germany

Site Status

Asahikawa Medical center

Asahikawa, Hokkaido, Japan

Site Status

Medical Corporation Abe Neurology Clinic

Morioka, Iwate, Japan

Site Status

Tazuke Kofukai Medical Research Institute Kitano Hospital

Kita-ku, Osaka, Japan

Site Status

Osaka University Hospital

Suita, Osaka, Japan

Site Status

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Site Status

Hospital Clinico Universitario

Santiago de Compostela, A Coruna, Spain

Site Status

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Policlinica de Guipuzcoa

Donostia / San Sebastian, Guipuzcoa, Spain

Site Status

Hospital Clinic i Provincial de Barcelona

Barcelona, , Spain

Site Status

Hospital Universitario de la Princesa

Madrid, , Spain

Site Status

Hospital Universitario y Politecnico la Fe

Valencia, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada France Germany Japan Spain

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://pmiform.com/clinical-trial-info-request?StudyID=B7601003

To obtain contact information for a study center near you, click here.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2015-004912-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A-ROSE PD

Identifier Type: OTHER

Identifier Source: secondary_id

A-ROSE

Identifier Type: OTHER

Identifier Source: secondary_id

B7601003

Identifier Type: -

Identifier Source: org_study_id