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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02687542
First Posted: February 22, 2016
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
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.

Condition Intervention Phase
Parkinson Disease Drug: Placebo Drug: PF-06649751 low dose (1 mg QD) Drug: PF-06649751 middle dose 1 (3 mg QD) Drug: PF-06649751 middle dose 2 (7 mg QD) Drug: PF-06649751 high dose (15 mg QD) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A 15-week, Phase 2, Double Blind, Randomized, Placebo-controlled, Dose Ranging Study To Investigate The Efficacy, Safety And Tolerability Of Pf-06649751 In Subjects With Motor Fluctuations Due To Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in daily OFF time [ Time Frame: Week 10. The baseline will be Day 0 (Randomization). ]
    Change from baseline in daily OFF time based on patient reported Hauser diary


Secondary Outcome Measures:
  • % reduction in total daily L-Dopa dose [ Time Frame: Weeks 10 and 15. The baseline will be Day 0 (Randomization). ]
    % reduction in total daily L-Dopa dose from pre-study baseline

  • Number of subjects with >=25, 50%, 75% and with 100% reduction in daily L-Dopa dose [ Time Frame: Weeks 10 and 15. The baseline will be Day 0 (Randomization). ]
    Number of subjects with >=25%, 50%, 75% and with 100% reduction from pre-study baseline in daily L-Dopa dose

  • Safety and Tolerability including AEs, Clinical laboratory, Vital signs, and ECG. [ Time Frame: From Randomization to Week 15 ]
  • Columbia Suicide Severity Rating Scale (C-SSRS) at end of treatment. [ Time Frame: From Randomization to Week 15 ]
    C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has subject engaged in non-suicidal self-injurious behavior")

  • Daily OFF time [ Time Frame: From Randomization to Week 15 ]
    Change from baseline in daily OFF time based on patient reported Hauser diary

  • Daily ON time without troublesome dyskinesia [ Time Frame: From Randomization to Week 15 ]
    Change from baseline in daily ON time without troublesome dyskinesia based on patient reported Hauser diary

  • MDS - UPDRS Part III [ Time Frame: From Randomization to Week 15 ]
    Based on Movement Disorder Society - Unified Parkinson's Disease Rating Scale.

  • MDS-UPDRS Parts I, II, IV, and total score [ Time Frame: From Randomization to Week 15 ]
    Based on Movement Disorder Society - Unified Parkinson's Disease Rating Scale


Enrollment: 106
Actual Study Start Date: March 3, 2016
Estimated Study Completion Date: December 17, 2018
Estimated Primary Completion Date: December 17, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo
Experimental: PF-06649751 low dose (1 mg QD)
PF-06649751 low dose level (1 mg QD)
Drug: PF-06649751 low dose (1 mg QD)
PF-06649751 low dose (1 mg QD)
Experimental: PF-06649751 middle dose 1 (3 mg QD)
PF-06649751 lower middle dose 1 (3 mg QD)
Drug: PF-06649751 middle dose 1 (3 mg QD)
PF-06649751 lower middle dose 1 (3 mg QD)
Experimental: PF-06649751 middle dose 2 (7 mg QD)
PF-06649751 higher middle dose 2 (7 mg QD)
Drug: PF-06649751 middle dose 2 (7 mg QD)
PF-06649751higher middle dose 2 (7 mg QD)
Experimental: PF-06649751 high dose (15 mg QD)
PF-06649751 high dose (15 mg QD)
Drug: PF-06649751 high dose (15 mg QD)
PF-06649751 high dose (15 mg QD)

Detailed 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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687542


  Hide Study Locations
Locations
United States, Arizona
Xenoscience, Inc
Phoenix, Arizona, United States, 85004
St Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
Arcadia Neurology Center
Arcadia, California, United States, 91006
Faculty Physicians and Surgeons of Loma Linda University School of Medicine
Loma Linda, California, United States, 92354
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92658
Hoag Memorial Hospital
Newport Beach, California, United States, 92663
SC3 Research Group, Inc
Pasadena, California, United States, 91105
Neurosearch-Torrance
Torrance, California, United States, 90505
United States, Connecticut
Associated Neurologists of Southern Connecticut, PC
Fairfield, Connecticut, United States, 06824
Hospital For Special Care
New Britain, Connecticut, United States, 06053
United States, Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
University of Florida Center for Movement Disorders and Neurorestoration
Gainesville, Florida, United States, 32607
Neurology Associates of Ormond Beach
Ormond Beach, Florida, United States, 32174
University of South Florida
Tampa, Florida, United States, 33613
Vero Neurology
Vero Beach, Florida, United States, 32960
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University Health Neuroscience Center
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Brigham and Women's Hospital (Investigational Drug Service)
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Lahey Hospital & Medical Center
Burlington, Massachusetts, United States, 01805
Lahey Hospital
Burlington, Massachusetts, United States, 01805
United States, New Jersey
CRI Worldwide, LLC
Marlton, New Jersey, United States, 08053
United States, New York
Dent Neurologic Institute
Amherst, New York, United States, 14226
Dent Neurosciences Research Center ,Inc. DBA Dent Neurologic Institute
Amherst, New York, United States, 14226
United States, North Carolina
Duke University Medical center
Durham, North Carolina, United States, 27705
Duke University/Duke Neurology/Department of Neurology
Durham, North Carolina, United States, 27705
Wake Research Associate, LLC
Raleigh, North Carolina, United States, 27612
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
University of Toledo
Toledo, Ohio, United States, 43614
United States, Oklahoma
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Abington Neurological Associates, Ltd.
Willow Grove, Pennsylvania, United States, 19090
United States, Rhode Island
Rhode Island Hospital/ Brown University Medical School
Providence, Rhode Island, United States, 02903
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Texas
Drug Supply: AS Clinical Research Consultants of North Texas, PLLC
Greenville, Texas, United States, 75401
Study Supply: AS Clinical Research Consultants of North Texas, PLLC
Greenville, Texas, United States, 75401
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Washington
Booth Gardner Parkinson's Care Center
Kirkland, Washington, United States, 98034
Canada, Ontario
London Health Sciences Centre-Movement Disorders Centre
London, Ontario, Canada, N6A5A5
Canada, Quebec
Montreal Neurological Hospital Research Pharmacy
Montreal, Quebec, Canada, H3A 2B4
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada, H3A 2B4
France
CHU de Grenoble Alpes
Grenoble, France, 38043 Cedex 9
CHU de Grenoble Alpes
La Tronche, France, 38700
CHRU de Lille
Lille Cedex, France, 59037
CHRU de Lille-Hôpital Roger Salengro
Lille, France, 59037 cedex
Hôpital de la Timone APHM
Marseille, France, 13385 cedex 05
Hôpital de La Timone
Marseille, France, 13385 cedex 05
Hôpital La Pitié-Salpêtrière
Paris, France, 75013
Hôpital La Pitié-Salpêtrière
Paris, France, 75651 cedex 13
Germany
Universitaetsklinikum Freiburg
Freiburg, Baden-wuerttemberg, Germany, 79106
Campus Charite Virchow des Universitaetsklinikums Charite
Berlin, Germany, 13353
St. Josef-Hospital GmbH
Bochum, Germany, 44791
Universitaetsklinikum Carl Gustav Carus Klinik und Poliklinik fur Neurologie
Dresden, Germany, 01307
Klinikum rechts der Isar der Technischen Universität München
München, Germany, 81675
Universitaetsklinik Ulm
Ulm, Germany, 89081
Japan
Asahikawa Medical center
Asahikawa, Hokkaido, Japan, 0708644
Medical Corporation Abe Neurology Clinic
Morioka, Iwate, Japan, 020-0878
Tazuke Kofukai Medical Research Institute Kitano Hospital
Kita-ku, Osaka, Japan, 530-8480
Osaka University Hospital
Suita, Osaka, Japan, 565-0871
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan, 113-8431
Spain
Hospital Clínico Universitario
Santiago de Compostela, A Coruña, Spain, 15706
Hospital Universitari de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Policlínica de Guipuzcoa
San Sebastián, Gipuzkoa, Spain, 20009
Policlínica de Guipuzcoa
San Sebastián, Guipúzcoa, Spain, 20009
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital Universitario de la Princesa
Madrid, Spain, 28006
Hospital Universitario y Politécnico la Fe
Valencia, Spain, 46026
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02687542     History of Changes
Other Study ID Numbers: B7601003
2015-004912-39 ( EudraCT Number )
A-ROSE PD ( Other Identifier: Alias Study Number )
A-ROSE ( Other Identifier: Alias Study Number )
First Submitted: January 29, 2016
First Posted: February 22, 2016
Last Update Posted: October 9, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
Parkinson Disease
Motor Fluctuation

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases