Back to results

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

Primary Purpose

Parkinson Disease

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Placebo

PF-06649751 low dose (1 mg QD)

PF-06649751 middle dose 1 (3 mg QD)

PF-06649751 middle dose 2 (7 mg QD)

PF-06649751 high dose (15 mg QD)

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson Disease, Motor Fluctuation

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Xenoscience, Inc
St Joseph's Hospital and Medical Center
Arcadia Neurology Center
Faculty Physicians and Surgeons of Loma Linda University School of Medicine
Hoag Memorial Hospital Presbyterian
Hoag Memorial Hospital
SC3 Research Group, Inc
Neurosearch-Torrance
Associated Neurologists of Southern Connecticut, PC
Parkinson's Disease and Movement Disorders Center of Boca Raton
University of Florida Center for Movement Disorders and Neurorestoration
Neurology Associates of Ormond Beach
University of South Florida
Vero Beach Neurology and Research Institute
Atlanta Center for Medical Research
Rush University Medical Center
Indiana University Health Neuroscience Center
Brigham and Women's Hospital
CRI Worldwide, LLC
Dent Neurologic Institute
Dent Neurosciences Research Center ,Inc. DBA Dent Neurologic Institute
Dent Neurologic Institute
Duke University Medical center
Duke University/Duke Neurology/Department of Neurology
Wake Research Associates, LLC
Cleveland Clinic
University of Toledo
The Movement Disorder Clinic of Oklahoma
Abington Neurological Associates, Ltd.
Rhode Island Hospital/ Brown University Medical School
AS Clinical Research Consultants of North Texas, PLLC
Baylor College of Medicine
Booth Gardner Parkinson's Care Center
Montreal Neurological Hospital Research Pharmacy
Montreal Neurological Institute and Hospital
CHU de Grenoble Alpes
CHU de Grenoble Alpes
CHRU de Lille-Hopital Roger Salengro
Hopital de la Timone APHM
Hopital de La Timone
Hopital La Pitie-Salpetriere
Universitaetsklinikum Freiburg
St. Josef-Hospital GmbH
Universitaetsklinikum Carl Gustav Carus Klinik und Poliklinik fur Neurologie
Klinikum rechts der Isar der Technischen Universitaet Muenchen
Universitaetsklinik Ulm
Asahikawa Medical center
Medical Corporation Abe Neurology Clinic
Tazuke Kofukai Medical Research Institute Kitano Hospital
Osaka University Hospital
Juntendo University Hospital
Hospital Clinico Universitario
Hospital Universitari de Bellvitge
Policlinica de Guipuzcoa
Hospital Clinic i Provincial de Barcelona
Hospital Universitario de la Princesa
Hospital Universitario y Politecnico la Fe

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

PF-06649751 low dose (1 mg QD)

PF-06649751 middle dose 1 (3 mg QD)

PF-06649751 middle dose 2 (7 mg QD)

PF-06649751 high dose (15 mg QD)

Arm Description

Placebo

PF-06649751 low dose level (1 mg QD)

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

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

PF-06649751 high dose (15 mg QD)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline in Daily OFF Time

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. Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10.

Change From Baseline in Daily ON Time With Troublesome Dyskinesia

A paper Hauser diary was utilized to record motor state for half hour intervals. The participants answered the Hauser diary on whether they had been ON with troublesome dyskinesia. A diary day started with the interval 24:00-0:30 through 23:30-24:00 on each chronological day for 3 consecutive days. On the days recording the home diary, participants made an entry every 30 minutes during their normal waking time and upon awakening from time asleep. The daily ON hours was calculated as the average of the 3 consecutive daily ON hours from the Hauser diary at each visit. Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10.

Change From Baseline in Daily ON Time Without Troublesome Dyskinesia

A paper Hauser diary was utilized to record motor state for half hour intervals. The participants answered the Hauser diary on whether they had been ON without troublesome dyskinesia. A diary day started with the interval 24:00-0:30 through 23:30-24:00 on each chronological day for 3 consecutive days. On the days recording the home diary, participants made an entry every 30 minutes during their normal waking time and upon awakening from time asleep. The daily ON hours was calculated as the average of the 3 consecutive daily ON hours from the Hauser diary at each visit. Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10.

Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III

MDS-UPDRS Part III assessed the motor signs of Parkinson's disease and was administered by the investigator. It was comprised of 33 sub-scores based on 18 items, several with right, left or other body distribution scores. Each question was anchored with 5 responses that were linked to commonly accepted clinical terms: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. If more than 7 of the Part III items were missing, the score for that time point was missing, otherwise MDS-UPDRS Part III score was imputed as sum of the non-missing items*(total number of items)/ (number of items non-missing). The MDS-UPDRS Part III total score range is 0-132. Higher score indicated more severe motor signs of Parkinson's disease. Results at Week 15 should be interpreted with caution given almost half the participants were not available for this analysis at Week 15 as compared to Week 10 and the complicated nature of protocol changes that impacted the study design after Week 10.

Change From Baseline in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, IV, and Total Score

Each question of Part I,II or IV with 5 responses was linked to the same clinical terms as Part III.The score was missing if more than 7 items were missing for a time point; otherwise Part I,II or IV score was imputed as sum of non-missing items*(total number of items)/(number of items non-missing).•PartI (Non-Motor Aspects of Experiences of Daily Living) assessed non-motor experiences of daily living using 13questions(Range:0-52).•PartII(Motor Aspects of Experiences of Daily Living) assessed motor experiences of daily living using 13questions(Range:0-52).•PartIV(Motor Complications) assessed motor complications,dyskinesias, and motor fluctuations using historical and objective information with 6questions(Range:0-24).•MDS-UPDRS Total Score:the sum of Parts I,II,III,and IV(Range:0-260).Higher score indicated more severe motor signs of Parkinson's disease.Week15's results were interpreted cautiously given almost half participants were not available for the analysis as compared to Week10

Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality

The safety laboratory tests including Hematology, Clinical Chemistry and Urinalysis were performed. Determination if there were any laboratory data abnormalities of potential clinical concern was based on Pfizer Data Standards. Incidence of laboratory test abnormalities (without regard to baseline abnormality) was summarized within each treatment group.

Number of Participants With Vital Sign Results Meeting the Criteria for Categorical Summarization

Vital Signs including blood pressure and pulse rate were measured. Vital signs were collected first while the participant was in the supine position and then in the standing position.

Number of Participants With Electrocardiogram (ECG) Results Meeting the Criteria for Categorical Summarization

The average of the triplicate readings of ECG data was collected at each assessment time. Number of participants with ECG results meeting the criteria for categorical summarization for time from the beginning of the P wave until the beginning of the QRS complex (PR Interval), time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization (QRS Duration), time between the start of the Q wave and the end of the T wave in the heart's electrical cycle (QT Interval) and corrected QT (Fridericia correction) (QTcF Interval) were presented.

Number of Participants With Suicidal Ideation Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) at Post-baseline Visits

The Columbia Suicide Severity Rating Scale (C-SSRS) was an interview based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS responses were mapped to the C-CASA. There were 3 key endpoints for suicidality data analysis and evaluation: Suicidal Behavior: A participant was said to have suicidal behavior if the participant had experienced completed suicide / suicide attempt / reparatory acts toward imminent suicidal behavior. Suicidal Ideation: Any observed suicidal ideation mapped to a single C-CASA category. Suicidal Behavior or Ideation (participants with new onset suicidality): A participant was considered to have a new onset of suicidality if the participant reported no ideation and no behavior at the baseline assessment and reported any behavior or ideation post-baseline. Data observed at screening was not considered in the definition of worsening.

Change From Baseline in Total Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)

The QUIP-RS was a brief, patient reported outcome measure designed to assess the severity of symptoms of Impulsive-Compulsive Disorders (ICDs) and related behaviors reported to occur in Parkinson's disease. The QUIP-RS assessed 7 disorders (Gambling, Sex, Buying, Eating, Hobbyism-punding [performing tasks and repeating activities] and Taking medications). If more than 5 items were missing, the total QUIP-RS score was set as missing; otherwise, the total QUIP-RS score was imputed as follows: sum of the non-missing item scores * (total number of items) / (number of items non-missing). The higher score indicated a greater level of the ICD. The total QUIP-RS score for all ICDs and related disorders combined ranges from 0 to 112.

Total Physician Withdrawal Checklist (PWC-20) on Days 105 and 119, and Change From Day 105 to Day 119

The PWC-20 is a physician completed, 20 item reliable and sensitive instrument for the assessment of discontinuation symptoms. The PWC-20 was collected after the completion of study treatment and also at the first visit of follow-up. The total PWC-20 score was the sum of 20 item scores and ranged from 0 to 60. If more than 5 items were missing, the total PWC-20 score was missing; otherwise, the total PWC-20 score was imputed as follows: sum of the non-missing items * (total number of items) / (number of items non-missing). The higher score indicated more frequent/severe symptoms.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths

An AE was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event did not need necessarily to have a causal relationship with the treatment or usage. An SAE was any untoward medical occurrence at any dose that: Resulted in death; Was life threatening (immediate risk of death); Required inpatient hospitalization or prolongation of existing hospitalization; Resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); Resulted in congenital anomaly/birth defect.

Full Information

NCT ID

NCT02687542

First Posted

January 29, 2016

Last Updated

October 28, 2020

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02687542

Brief Title

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

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Terminated

Why Stopped

Terminated 25Sep17 due to insufficient efficacy. Not due to safety reasons.

Study Start Date

March 3, 2016 (Actual)

Primary Completion Date

November 10, 2017 (Actual)

Study Completion Date

November 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

Parkinson Disease, Motor Fluctuation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

PF-06649751 low dose (1 mg QD)

Arm Type

Experimental

Arm Description

PF-06649751 low dose level (1 mg QD)

Arm Title

PF-06649751 middle dose 1 (3 mg QD)

Arm Type

Experimental

Arm Description

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

Arm Title

PF-06649751 middle dose 2 (7 mg QD)

Arm Type

Experimental

Arm Description

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

Arm Title

PF-06649751 high dose (15 mg QD)

Arm Type

Experimental

Arm Description

PF-06649751 high dose (15 mg QD)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo

Intervention Type

Drug

Intervention Name(s)

PF-06649751 low dose (1 mg QD)

Intervention Description

PF-06649751 low dose (1 mg QD)

Intervention Type

Drug

Intervention Name(s)

PF-06649751 middle dose 1 (3 mg QD)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

PF-06649751 middle dose 2 (7 mg QD)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

PF-06649751 high dose (15 mg QD)

Intervention Description

PF-06649751 high dose (15 mg QD)

Primary Outcome Measure Information:

Title

Change From Baseline in Daily OFF Time at Week 10

Description

Time Frame

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 Information:

Title

Change From Baseline in Daily OFF Time

Description

Time Frame

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).

Title

Change From Baseline in Daily ON Time With Troublesome Dyskinesia

Description

Time Frame

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).

Title

Change From Baseline in Daily ON Time Without Troublesome Dyskinesia

Description

Time Frame

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)

Title

Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III

Description

Time Frame

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

Title

Change From Baseline in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, IV, and Total Score

Description

Time Frame

Weeks 5, 10 and 15; Baseline was defined as the Day -1 (study derived day and equalled to nominal visit Day 0) measurement

Title

Number of Participants With Laboratory Abnormalities Without Regard to Baseline Abnormality

Description

Time Frame

Baseline (Day 0) to Week 17

Title

Number of Participants With Vital Sign Results Meeting the Criteria for Categorical Summarization

Description

Vital Signs including blood pressure and pulse rate were measured. Vital signs were collected first while the participant was in the supine position and then in the standing position.

Time Frame

Baseline (Day 0) to Week 17

Title

Number of Participants With Electrocardiogram (ECG) Results Meeting the Criteria for Categorical Summarization

Description

Time Frame

Baseline (Day 0) to Week 17

Title

Number of Participants With Suicidal Ideation Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS) at Post-baseline Visits

Description

Time Frame

Days 0 (Baseline), 7, 14, 21, 28, 35, 70, 77, 84, 91, 105 and 119

Title

Change From Baseline in Total Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS)

Description

Time Frame

Baseline (Day 0) and Weeks 5, 10 and 15

Title

Total Physician Withdrawal Checklist (PWC-20) on Days 105 and 119, and Change From Day 105 to Day 119

Description

Time Frame

Days 105 and 119

Title

Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs and Deaths

Description

Time Frame

Day 1 to follow-up (Week 19 visit)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Xenoscience, Inc

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85004

Country

United States

Facility Name

St Joseph's Hospital and Medical Center

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85013

Country

United States

Facility Name

Arcadia Neurology Center

City

Arcadia

State/Province

California

ZIP/Postal Code

91006

Country

United States

Facility Name

Faculty Physicians and Surgeons of Loma Linda University School of Medicine

City

Loma Linda

State/Province

California

ZIP/Postal Code

92354

Country

United States

Facility Name

Hoag Memorial Hospital Presbyterian

City

Newport Beach

State/Province

California

ZIP/Postal Code

92658

Country

United States

Facility Name

Hoag Memorial Hospital

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

SC3 Research Group, Inc

City

Pasadena

State/Province

California

ZIP/Postal Code

91105

Country

United States

Facility Name

Neurosearch-Torrance

City

Torrance

State/Province

California

ZIP/Postal Code

90505

Country

United States

Facility Name

Associated Neurologists of Southern Connecticut, PC

City

Fairfield

State/Province

Connecticut

ZIP/Postal Code

06824

Country

United States

Facility Name

Parkinson's Disease and Movement Disorders Center of Boca Raton

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

University of Florida Center for Movement Disorders and Neurorestoration

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32607

Country

United States

Facility Name

Neurology Associates of Ormond Beach

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

University of South Florida

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Vero Beach Neurology and Research Institute

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

Facility Name

Atlanta Center for Medical Research

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30331

Country

United States

Facility Name

Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Indiana University Health Neuroscience Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Brigham and Women's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

CRI Worldwide, LLC

City

Marlton

State/Province

New Jersey

ZIP/Postal Code

08053

Country

United States

Facility Name

Dent Neurologic Institute

City

Amherst

State/Province

New York

ZIP/Postal Code

14226

Country

United States

Facility Name

Dent Neurosciences Research Center ,Inc. DBA Dent Neurologic Institute

City

Amherst

State/Province

New York

ZIP/Postal Code

14226

Country

United States

Facility Name

Dent Neurologic Institute

City

Orchard Park

State/Province

New York

ZIP/Postal Code

14127

Country

United States

Facility Name

Duke University Medical center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Facility Name

Duke University/Duke Neurology/Department of Neurology

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Facility Name

Wake Research Associates, LLC

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

University of Toledo

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43614

Country

United States

Facility Name

The Movement Disorder Clinic of Oklahoma

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

Abington Neurological Associates, Ltd.

City

Willow Grove

State/Province

Pennsylvania

ZIP/Postal Code

19090

Country

United States

Facility Name

Rhode Island Hospital/ Brown University Medical School

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

AS Clinical Research Consultants of North Texas, PLLC

City

Greenville

State/Province

Texas

ZIP/Postal Code

75401

Country

United States

Facility Name

Baylor College of Medicine

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Booth Gardner Parkinson's Care Center

City

Kirkland

State/Province

Washington

ZIP/Postal Code

98034

Country

United States

Facility Name

Montreal Neurological Hospital Research Pharmacy

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 2B4

Country

Canada

Facility Name

Montreal Neurological Institute and Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 2B4

Country

Canada

Facility Name

CHU de Grenoble Alpes

City

Grenoble

ZIP/Postal Code

38043 Cedex 9

Country

France

Facility Name

CHU de Grenoble Alpes

City

La Tronche

ZIP/Postal Code

38700

Country

France

Facility Name

CHRU de Lille-Hopital Roger Salengro

City

Lille

ZIP/Postal Code

59037 cedex

Country

France

Facility Name

Hopital de la Timone APHM

City

Marseille

ZIP/Postal Code

13385 cedex 05

Country

France

Facility Name

Hopital de La Timone

City

Marseille

ZIP/Postal Code

13385 cedex 05

Country

France

Facility Name

Hopital La Pitie-Salpetriere

City

Paris

ZIP/Postal Code

75013

Country

France

Facility Name

Universitaetsklinikum Freiburg

City

Freiburg

State/Province

Baden-wuerttemberg

ZIP/Postal Code

79106

Country

Germany

Facility Name

St. Josef-Hospital GmbH

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Universitaetsklinikum Carl Gustav Carus Klinik und Poliklinik fur Neurologie

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Klinikum rechts der Isar der Technischen Universitaet Muenchen

City

Muenchen

ZIP/Postal Code

81675

Country

Germany

Facility Name

Universitaetsklinik Ulm

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Asahikawa Medical center

City

Asahikawa

State/Province

Hokkaido

ZIP/Postal Code

0708644

Country

Japan

Facility Name

Medical Corporation Abe Neurology Clinic

City

Morioka

State/Province

Iwate

ZIP/Postal Code

020-0878

Country

Japan

Facility Name

Tazuke Kofukai Medical Research Institute Kitano Hospital

City

Kita-ku

State/Province

Osaka

ZIP/Postal Code

530-8480

Country

Japan

Facility Name

Osaka University Hospital

City

Suita

State/Province

Osaka

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

Juntendo University Hospital

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

Hospital Clinico Universitario

City

Santiago de Compostela

State/Province

A Coruna

ZIP/Postal Code

15706

Country

Spain

Facility Name

Hospital Universitari de Bellvitge

City

Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Policlinica de Guipuzcoa

City

San Sebastian

State/Province

Guipuzcoa

ZIP/Postal Code

20009

Country

Spain

Facility Name

Hospital Clinic i Provincial de Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital Universitario de la Princesa

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Hospital Universitario y Politecnico la Fe

City

Valencia

ZIP/Postal Code

46026

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

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.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Links:

URL

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

Description

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs