Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02847650
Recruitment Status : Terminated (Study B7601011 was terminated on 29 Jan 2018 due to lack of efficacy in moderate/advanced Parkinson's disease.)
First Posted : July 28, 2016
Last Update Posted : March 5, 2018
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Placebo Drug: PF-06649751 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : October 17, 2016
Actual Primary Completion Date : January 29, 2018
Actual Study Completion Date : January 29, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Other Name: oral tablet once daily

Experimental: PF-06649751 Drug: PF-06649751
Other Name: flexible dose oral tablet once daily

Primary Outcome Measures :
  1. Change from baseline in the Modified Unified Parkinson's Disease Rating Scale (MDS UPDRS) Score Part III [ Time Frame: Baseline, 15 weeks ]

Secondary Outcome Measures :
  1. Columbia Suicide Severity Rating Scale (C SSRS) [ Time Frame: Baseline, day 7, 14, 21, 35, 49, 63, 84, 105, 119 ]
  2. • Questionnaire for Impulsive Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP RS) [ Time Frame: baseline, day 35, 63, 105 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02847650

  Show 37 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT02847650     History of Changes
Other Study ID Numbers: B7601011
2016-001575-71 ( EudraCT Number )
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
Early Parkinson Disease
Phase 2

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases