NCT02847650

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751 in Parkinson's disease patients at early stage of the disease.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for phase_2 parkinson-disease

Timeline
Completed

Started Oct 2016

Shorter than P25 for phase_2 parkinson-disease

Geographic Reach
4 countries

37 active sites

Status
terminated

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

July 25, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

October 17, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2018

Completed
12 months until next milestone

Results Posted

Study results publicly available

January 15, 2019

Completed
Last Updated

November 23, 2020

Status Verified

October 1, 2020

Enrollment Period

1.3 years

First QC Date

July 25, 2016

Results QC Date

December 18, 2018

Last Update Submit

October 28, 2020

Conditions

Parkinson Disease

Keywords

Early Parkinson DiseasePhase 2

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Total Score at Week 15

    MDS-UPDRS Part III was used to assess the motor signs of Parkinson's disease. 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. The MDS-UPDRS Part III total score range is 0-132. Higher score indicates more severe motor signs of Parkinson's disease. A negative change from baseline represents an improvement in motor function.

    Baseline (Day -1/randomization), Week 15

Secondary Outcomes (7)

  • Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    From first dose of study treatment up to 28 days after last dose (up to Day 133)

  • Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)

    Baseline (Day -1/randomization) up to Day 119 follow-up visit

  • Number of Participants With Vital Signs Data Meeting Categorical Summarization and Orthostatic Hypotension Criteria

    Baseline (Day -1/randomization) up to Day 119 follow-up visit

  • Number of Participants Meeting the Categorical Summarization Criteria for Electrocardiogram (ECG) Parameters

    Baseline (Day -1/randomization) up to Day 119 follow-up visit

  • Number of Participants With Worsening and New Onset Suicidality as Assessed by Columbia Suicide Severity Rating Scale (C-SSRS)

    Baseline (Day -1/randomization) up to Day 119 follow-up visit

  • +2 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

PF-06649751

EXPERIMENTAL
Drug: PF-06649751

Interventions

PlaceboDRUG
Also known as: oral tablet once daily
Placebo
PF-06649751DRUG
Also known as: flexible dose oral tablet once daily
PF-06649751

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females of non-childbearing potential and/or male subjects
  • Clinical diagnosis of Parkinson's disease.
  • Parkinson's Disease Hoehn \& Yahr Stage I-III inclusive
  • Treatment naïve or history of prior incidental treatment with dopaminergic agents for no more than 28 days
  • Able to refrain from any Parkinson's disease medication not permitted by the protocol.

You may not qualify if:

  • History or presence of atypical Parkinsonian syndrome.
  • Severe acute or chronic medical or psychiatric condition or cognitive impairment 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

Study Sites (37)

St Joseph's Hospital and Medical Center, Barrow Neurology Clinics

Phoenix, Arizona, 85013, United States

Location

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

University of South Florida Carol and Frank Morsani Center for Advanced Health Care

Tampa, Florida, 33612, United States

Location

University of South Florida Faculty Office Building

Tampa, Florida, 33612, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

University of South Florida Parkinson's Disease and Movement Disorders Center

Tampa, Florida, 33613, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Asheville Neurology Specialists PA

Asheville, North Carolina, 28806, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Toledo, Gardner-McMaster Parkinson Center

Toledo, Ohio, 43614, United States

Location

University of Toledo

Toledo, Ohio, 43614, United States

Location

AS Clinical Research Consultants of North Texas, PLLC

Greenville, Texas, 75401, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Sentara Neurology Specialists

Virginia Beach, Virginia, 23456, United States

Location

Hopital Henri Mondor

Créteil, 94010, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

CHU de Grenoble Alpes

Grenoble, 38043, France

Location

CHU Grenoble Alpes

La Tronche, 38700, France

Location

Hospital de La Timone

Marseille, 13385 Cedex 05, France

Location

Hospital La Timone

Marseille, 13385 cedex 05, France

Location

Hopital Pitie Salpetriere

Paris, 75013, France

Location

Hopital Pitie-Salpetriere

Paris, 75651 cedex 13, France

Location

St. Josef Hospital GmbH

Bochum, North Rhine-Westphalia, 44791, Germany

Location

Praxis Oehlwein Outpatient clinic for PD, DBS, Movement Disorders

Gera, 07551, Germany

Location

Klinik Haag i. OB

Haag I. OB, 83527, Germany

Location

Paracelsus-Elena-Klinik Kassel

Kassel, 34128, Germany

Location

Universitätsklinikum Gießen und Marburg GmbH

Marburg, 35043, Germany

Location

University hospital Tuebingen

Tübingen, 72076, Germany

Location

Universitaetsklinik Ulm

Ulm, 89081, Germany

Location

Edith Wolfson Medical Center

Holon, 58100, Israel

Location

Pharmacy, Edith Wolfson Medical Center

Holon, 58100, Israel

Location

Related Publications (1)

  • Riesenberg R, Werth J, Zhang Y, Duvvuri S, Gray D. PF-06649751 efficacy and safety in early Parkinson's disease: a randomized, placebo-controlled trial. Ther Adv Neurol Disord. 2020 Mar 6;13:1756286420911296. doi: 10.1177/1756286420911296. eCollection 2020.

    PMID: 32201505DERIVED

Related Links

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Limitations and Caveats

This study was terminated early by the sponsor due to a companion study, B7601003 (NCT02687542; a dose ranging, Phase 2b study in motor fluctuators) meeting futility criteria at Interim Analysis.

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

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

July 25, 2016

First Posted

July 28, 2016

Study Start

October 17, 2016

Primary Completion

January 29, 2018

Study Completion

January 29, 2018

Last Updated

November 23, 2020

Results First Posted

January 15, 2019

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.

More information

Locations

FR(8)IL(2)US(20)DE(7)