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

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

Sponsors

Lead sponsor: Pfizer

Source Pfizer
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.

Overall Status Terminated
Start Date March 3, 2016
Completion Date November 10, 2017
Primary Completion Date November 10, 2017
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change From Baseline in Daily OFF Time at Week 10 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 Outcome
Measure Time Frame
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
Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality Baseline (Day 0) to Week 17
Number of Participants With Vital Sign Results Meeting the Criteria for Categorical Summarization Baseline (Day 0) to Week 17
Number of Participants With Electrocardiogram (ECG) Results Meeting the Criteria for Categorical Summarization Baseline (Day 0) to Week 17
Number of Participants With Suicidal Ideation Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) at Post-baseline Visits Days 0 (Baseline), 7, 14, 21, 28, 35, 70, 77, 84, 91, 105 and 119
Change From Baseline in Total Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS) Baseline (Day 0) and Weeks 5, 10 and 15
Total Physician Withdrawal Checklist (PWC-20) on Days 105 and 119, and Change From Day 105 to Day 119 Days 105 and 119
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths Day 1 to follow-up (Week 19 visit)
Enrollment 108
Condition
Intervention

Intervention type: Drug

Intervention name: Placebo

Description: Placebo

Arm group label: Placebo

Intervention type: Drug

Intervention name: PF-06649751 low dose (1 mg QD)

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

Arm group label: PF-06649751 low dose (1 mg QD)

Intervention type: Drug

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

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

Arm group label: PF-06649751 middle dose 1 (3 mg QD)

Intervention type: Drug

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

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

Arm group label: PF-06649751 middle dose 2 (7 mg QD)

Intervention type: Drug

Intervention name: PF-06649751 high dose (15 mg QD)

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

Arm group label: PF-06649751 high dose (15 mg QD)

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.

Gender: All

Minimum age: 40 Years

Maximum age: 85 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Pfizer CT.gov Call Center Study Director Pfizer
Location
facility
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, Baden-wuerttemberg, 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 | Muenchen, 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 | Hospitalet de Llobregat, Barcelona, 08907, Spain
Policlinica de Guipuzcoa | 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
Location Countries

Canada

France

Germany

Japan

Spain

United States

Verification Date

December 2018

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: Placebo

Arm group label: PF-06649751 low dose (1 mg QD)

Arm group type: Experimental

Description: PF-06649751 low dose level (1 mg QD)

Arm group label: PF-06649751 middle dose 1 (3 mg QD)

Arm group type: Experimental

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

Arm group label: PF-06649751 middle dose 2 (7 mg QD)

Arm group type: Experimental

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

Arm group label: PF-06649751 high dose (15 mg QD)

Arm group type: Experimental

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

Study Design Info

Allocation: Randomized

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov