Study Stopped
Terminated 25Sep17 due to insufficient efficacy. Not due to safety reasons.
Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations
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
4 other identifiers
interventional
108
6 countries
57
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 parkinson-disease
Started Mar 2016
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2016
CompletedFirst Posted
Study publicly available on registry
February 22, 2016
CompletedStudy Start
First participant enrolled
March 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2017
CompletedResults Posted
Study results publicly available
December 24, 2018
CompletedNovember 23, 2020
October 1, 2020
1.7 years
January 29, 2016
October 30, 2018
October 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Daily OFF Time at Week 10
A paper Hauser diary was utilized to record motor state for half-hour intervals. Participants completed the diary by answering whether they had been OFF for 3 consecutive days in the week prior to each visit (except Day 28 visit), including 3 consecutive days during the week prior to Day 0 (Randomization). The daily OFF time was calculated as the average of the 3 consecutive daily OFF hours from the Hauser diary at each visit.
Week 10; Baseline was defined as the average daily OFF time (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit day 0).
Secondary Outcomes (12)
Change From Baseline in Daily OFF Time
Weeks 3, 5, 10 and 15; Baseline was defined as the average daily OFF time (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit day 0).
Change From Baseline in Daily ON Time With Troublesome Dyskinesia
Weeks 3, 5, 10 and 15; Baseline was defined as the average daily ON time with Troublesome Dyskinesia (using 3 Hauser patient diary Days) prior to Day -1 (study derived day and equalled to nominal visit Day 0).
Change From Baseline in Daily ON Time Without Troublesome Dyskinesia
Weeks 3, 5, 10 and 15; Baseline was defined as the average daily ON time without Troublesome Dyskinesia (using 3 Hauser patient diary days) prior to Day -1 (study derived day and equalled to nominal visit Day 0)
Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
Weeks 1, 2, 3, 4, 5, 10 and 15; Baseline was defined as the Day -1 (study derived day and equalled to nominal visit Day 0) measurement
Change From Baseline in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, IV, and Total Score
Weeks 5, 10 and 15; Baseline was defined as the Day -1 (study derived day and equalled to nominal visit Day 0) measurement
- +7 more secondary outcomes
Study Arms (5)
Placebo
PLACEBO COMPARATORPlacebo
PF-06649751 low dose (1 mg QD)
EXPERIMENTALPF-06649751 low dose level (1 mg QD)
PF-06649751 middle dose 1 (3 mg QD)
EXPERIMENTALPF-06649751 lower middle dose 1 (3 mg QD)
PF-06649751 middle dose 2 (7 mg QD)
EXPERIMENTALPF-06649751 higher middle dose 2 (7 mg QD)
PF-06649751 high dose (15 mg QD)
EXPERIMENTALPF-06649751 high dose (15 mg QD)
Interventions
PF-06649751 lower middle dose 1 (3 mg QD)
PF-06649751higher middle dose 2 (7 mg QD)
PF-06649751 high dose (15 mg QD)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (57)
Xenoscience, Inc
Phoenix, Arizona, 85004, United States
St Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Arcadia Neurology Center
Arcadia, California, 91006, United States
Faculty Physicians and Surgeons of Loma Linda University School of Medicine
Loma Linda, California, 92354, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92658, United States
Hoag Memorial Hospital
Newport Beach, California, 92663, United States
SC3 Research Group, Inc
Pasadena, California, 91105, United States
Neurosearch-Torrance
Torrance, California, 90505, United States
Associated Neurologists of Southern Connecticut, PC
Fairfield, Connecticut, 06824, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486, United States
University of Florida Center for Movement Disorders and Neurorestoration
Gainesville, Florida, 32607, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174, United States
University of South Florida
Tampa, Florida, 33613, United States
Vero Beach Neurology and Research Institute
Vero Beach, Florida, 32960, United States
Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Indiana University Health Neuroscience Center
Indianapolis, Indiana, 46202, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
CRI Worldwide, LLC
Marlton, New Jersey, 08053, United States
Dent Neurologic Institute
Amherst, New York, 14226, United States
Dent Neurosciences Research Center ,Inc. DBA Dent Neurologic Institute
Amherst, New York, 14226, United States
Dent Neurologic Institute
Orchard Park, New York, 14127, United States
Duke University Medical center
Durham, North Carolina, 27705, United States
Duke University/Duke Neurology/Department of Neurology
Durham, North Carolina, 27705, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Toledo
Toledo, Ohio, 43614, United States
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, 74136, United States
Abington Neurological Associates, Ltd.
Willow Grove, Pennsylvania, 19090, United States
Rhode Island Hospital/ Brown University Medical School
Providence, Rhode Island, 02903, United States
AS Clinical Research Consultants of North Texas, PLLC
Greenville, Texas, 75401, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Booth Gardner Parkinson's Care Center
Kirkland, Washington, 98034, United States
Montreal Neurological Hospital Research Pharmacy
Montreal, Quebec, H3A 2B4, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4, Canada
CHU de Grenoble Alpes
Grenoble, 38043 Cedex 9, France
CHU de Grenoble Alpes
La Tronche, 38700, France
CHRU de Lille-Hopital Roger Salengro
Lille, 59037 cedex, France
Hopital de la Timone APHM
Marseille, 13385 cedex 05, France
Hopital de La Timone
Marseille, 13385 cedex 05, France
Hopital La Pitie-Salpetriere
Paris, 75013, France
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
St. Josef-Hospital GmbH
Bochum, 44791, Germany
Universitaetsklinikum Carl Gustav Carus Klinik und Poliklinik fur Neurologie
Dresden, 01307, Germany
Klinikum rechts der Isar der Technischen Universitaet Muenchen
München, 81675, Germany
Universitaetsklinik Ulm
Ulm, 89081, Germany
Asahikawa Medical center
Asahikawa, Hokkaido, 0708644, Japan
Medical Corporation Abe Neurology Clinic
Morioka, Iwate, 020-0878, Japan
Tazuke Kofukai Medical Research Institute Kitano Hospital
Kita-ku, Osaka, 530-8480, Japan
Osaka University Hospital
Suita, Osaka, 565-0871, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431, Japan
Hospital Clinico Universitario
Santiago de Compostela, A Coruna, 15706, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Policlinica de Guipuzcoa
Donostia / San Sebastian, Guipuzcoa, 20009, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036, Spain
Hospital Universitario de la Princesa
Madrid, 28006, Spain
Hospital Universitario y Politecnico la Fe
Valencia, 46026, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated prematurely due to insufficient efficacy and not due to safety reasons.
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2016
First Posted
February 22, 2016
Study Start
March 3, 2016
Primary Completion
November 10, 2017
Study Completion
November 10, 2017
Last Updated
November 23, 2020
Results First Posted
December 24, 2018
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.