Clinical trial NCT02847650: Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease
Official title: A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON'S DISEASE
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Parkinson Disease
Keywords: Early Parkinson Disease
Phase 2
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2016-07-28
Enrollment: 57
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
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 at early stage of the disease.

Detailed description: The B7601011 study has a randomized, double-blind, placebo-controlled parallel group design. Approximately 88 subjects will be randomized to 2 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
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Total Score at Week 15
timeFrame: Baseline (Day -1/randomization), Week 15
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From first dose of study treatment up to 28 days after last dose (up to Day 133)
measure: Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
timeFrame: Baseline (Day -1/randomization) up to Day 119 follow-up visit
measure: Number of Participants With Vital Signs Data Meeting Categorical Summarization and Orthostatic Hypotension Criteria
timeFrame: Baseline (Day -1/randomization) up to Day 119 follow-up visit
measure: Number of Participants Meeting the Categorical Summarization Criteria for Electrocardiogram (ECG) Parameters
timeFrame: Baseline (Day -1/randomization) up to Day 119 follow-up visit
measure: Number of Participants With Worsening and New Onset Suicidality as Assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline (Day -1/randomization) up to Day 119 follow-up visit
measure: Change From Baseline in Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS) Total Score at Days 35, 63, and 105
timeFrame: Baseline (Day -1 or randomization); Days 35, 63, 105
measure: Total Physician Withdrawal Checklist (PWC-20) Score
timeFrame: Day 119
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St Joseph's Hospital and Medical Center, Barrow Neurology Clinics
state: Arizona
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: University of South Florida Carol and Frank Morsani Center for Advanced Health Care
state: Florida
city: Tampa
country: United States
facility: University of South Florida Faculty Office Building
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida Parkinson's Disease and Movement Disorders Center
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: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Asheville
country: United States
facility: Asheville Neurology Specialists PA
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Toledo
country: United States
facility: University of Toledo, Gardner-McMaster Parkinson Center
state: Ohio
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
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: Virginia Beach
country: United States
facility: Sentara Neurology Specialists
state: Virginia
city: CRÉTEIL Cedex
country: France
facility: Hôpital Henri Mondor
city: Créteil
country: France
facility: Hopital Henri Mondor
city: Grenoble
country: France
facility: CHU de Grenoble Alpes
city: La Tronche
country: France
facility: CHU Grenoble Alpes
city: Marseille
country: France
facility: Hospital de La Timone
city: Marseille
country: France
facility: Hospital La Timone
city: Paris
country: France
facility: Hopital Pitie Salpetriere
city: Paris
country: France
facility: Hopital Pitie-Salpetriere
city: Bochum
country: Germany
facility: St. Josef Hospital GmbH
state: Nordrhein-westfalen
city: Gera
country: Germany
facility: Praxis Oehlwein Outpatient clinic for PD, DBS, Movement Disorders
city: Haag I. OB
country: Germany
facility: Klinik Haag i. OB
city: Kassel
country: Germany
facility: Paracelsus-Elena-Klinik Kassel
city: Marburg
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH
city: Tuebingen
country: Germany
facility: University hospital Tuebingen
city: Ulm
country: Germany
facility: Universitaetsklinik Ulm
city: Holon
country: Israel
facility: Edith Wolfson Medical Center
city: Holon
country: Israel
facility: Pharmacy, Edith Wolfson Medical Center
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.