Clinical trial NCT02687542: Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Motor Fluctuation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-02-22
Enrollment: 108
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Change From Baseline in Daily OFF Time at Week 10
timeFrame: 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:
measure: Change From Baseline in Daily OFF Time
timeFrame: 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).
measure: Change From Baseline in Daily ON Time With Troublesome Dyskinesia
timeFrame: 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).
measure: Change From Baseline in Daily ON Time Without Troublesome Dyskinesia
timeFrame: 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)
measure: Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
timeFrame: 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
measure: Change From Baseline in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, IV, and Total Score
timeFrame: Weeks 5, 10 and 15; Baseline was defined as the Day -1 (study derived day and equalled to nominal visit Day 0) measurement
measure: Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality
timeFrame: Baseline (Day 0) to Week 17
measure: Number of Participants With Vital Sign Results Meeting the Criteria for Categorical Summarization
timeFrame: Baseline (Day 0) to Week 17
measure: Number of Participants With Electrocardiogram (ECG) Results Meeting the Criteria for Categorical Summarization
timeFrame: Baseline (Day 0) to Week 17
measure: Number of Participants With Suicidal Ideation Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) at Post-baseline Visits
timeFrame: Days 0 (Baseline), 7, 14, 21, 28, 35, 70, 77, 84, 91, 105 and 119
measure: Change From Baseline in Total Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)
timeFrame: Baseline (Day 0) and Weeks 5, 10 and 15
measure: Total Physician Withdrawal Checklist (PWC-20) on Days 105 and 119, and Change From Day 105 to Day 119
timeFrame: Days 105 and 119
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths
timeFrame: Day 1 to follow-up (Week 19 visit)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Xenoscience, Inc
state: Arizona
city: Phoenix
country: United States
facility: St Joseph's Hospital and Medical Center
state: Arizona
city: Arcadia
country: United States
facility: Arcadia Neurology Center
state: California
city: Loma Linda
country: United States
facility: Faculty Physicians and Surgeons of Loma Linda University School of Medicine
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital
state: California
city: Pasadena
country: United States
facility: SC3 Research Group, Inc
state: California
city: Torrance
country: United States
facility: Neurosearch-Torrance
state: California
city: Fairfield
country: United States
facility: Associated Neurologists of Southern Connecticut, PC
state: Connecticut
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: Gainesville
country: United States
facility: University of Florida Center for Movement Disorders and Neurorestoration
state: Florida
city: Ormond Beach
country: United States
facility: Neurology Associates of Ormond Beach
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Vero Beach
country: United States
facility: Vero Beach Neurology and Research Institute
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health Neuroscience Center
state: Indiana
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Marlton
country: United States
facility: CRI Worldwide, LLC
state: New Jersey
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
city: Amherst
country: United States
facility: Dent Neurosciences Research Center ,Inc. DBA Dent Neurologic Institute
state: New York
city: Orchard Park
country: United States
facility: Dent Neurologic Institute
state: New York
city: Durham
country: United States
facility: Duke University Medical center
state: North Carolina
city: Durham
country: United States
facility: Duke University/Duke Neurology/Department of Neurology
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
city: Tulsa
country: United States
facility: The Movement Disorder Clinic of Oklahoma
state: Oklahoma
city: Willow Grove
country: United States
facility: Abington Neurological Associates, Ltd.
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital/ Brown University Medical School
state: Rhode Island
city: Greenville
country: United States
facility: AS Clinical Research Consultants of North Texas, PLLC
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Kirkland
country: United States
facility: Booth Gardner Parkinson's Care Center
state: Washington
city: Montreal
country: Canada
facility: Montreal Neurological Hospital Research Pharmacy
state: Quebec
city: Montreal
country: Canada
facility: Montreal Neurological Institute and Hospital
state: Quebec
city: Grenoble
country: France
facility: CHU de Grenoble Alpes
city: La Tronche
country: France
facility: CHU de Grenoble Alpes
city: Lille
country: France
facility: CHRU de Lille-Hopital Roger Salengro
city: Marseille
country: France
facility: Hopital de la Timone APHM
city: Marseille
country: France
facility: Hopital de La Timone
city: Paris
country: France
facility: Hopital La Pitie-Salpetriere
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg
state: Baden-wuerttemberg
city: Bochum
country: Germany
facility: St. Josef-Hospital GmbH
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Klinik und Poliklinik fur Neurologie
city: Muenchen
country: Germany
facility: Klinikum rechts der Isar der Technischen Universitaet Muenchen
city: Ulm
country: Germany
facility: Universitaetsklinik Ulm
city: Asahikawa
country: Japan
facility: Asahikawa Medical center
state: Hokkaido
city: Morioka
country: Japan
facility: Medical Corporation Abe Neurology Clinic
state: Iwate
city: Kita-ku
country: Japan
facility: Tazuke Kofukai Medical Research Institute Kitano Hospital
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario
state: A Coruna
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: San Sebastian
country: Spain
facility: Policlinica de Guipuzcoa
state: Guipuzcoa
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico la Fe
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: