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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02687542
First Posted: February 22, 2016
Last Update Posted: October 9, 2017
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.
Information provided by (Responsible Party):
Pfizer
  Purpose
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.

Condition Intervention Phase
Parkinson Disease Drug: Placebo Drug: PF-06649751 low dose (1 mg QD) Drug: PF-06649751 middle dose 1 (3 mg QD) Drug: PF-06649751 middle dose 2 (7 mg QD) Drug: PF-06649751 high dose (15 mg QD) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from baseline in daily OFF time [ Time Frame: Week 10. The baseline will be Day 0 (Randomization). ]
    Change from baseline in daily OFF time based on patient reported Hauser diary


Secondary Outcome Measures:
  • % reduction in total daily L-Dopa dose [ Time Frame: Weeks 10 and 15. The baseline will be Day 0 (Randomization). ]
    % reduction in total daily L-Dopa dose from pre-study baseline

  • Number of subjects with >=25, 50%, 75% and with 100% reduction in daily L-Dopa dose [ Time Frame: Weeks 10 and 15. The baseline will be Day 0 (Randomization). ]
    Number of subjects with >=25%, 50%, 75% and with 100% reduction from pre-study baseline in daily L-Dopa dose

  • Safety and Tolerability including AEs, Clinical laboratory, Vital signs, and ECG. [ Time Frame: From Randomization to Week 15 ]
  • Columbia Suicide Severity Rating Scale (C-SSRS) at end of treatment. [ Time Frame: From Randomization to Week 15 ]
    C-SSRS assessed whether participant experienced following: completed suicide (1), suicide attempt (2) (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (3)("Yes" on "preparatory acts or behavior"), suicidal ideation (4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior (7)("Yes" on "Has subject engaged in non-suicidal self-injurious behavior")

  • Daily OFF time [ Time Frame: From Randomization to Week 15 ]
    Change from baseline in daily OFF time based on patient reported Hauser diary

  • Daily ON time without troublesome dyskinesia [ Time Frame: From Randomization to Week 15 ]
    Change from baseline in daily ON time without troublesome dyskinesia based on patient reported Hauser diary

  • MDS - UPDRS Part III [ Time Frame: From Randomization to Week 15 ]
    Based on Movement Disorder Society - Unified Parkinson's Disease Rating Scale.

  • MDS-UPDRS Parts I, II, IV, and total score [ Time Frame: From Randomization to Week 15 ]
    Based on Movement Disorder Society - Unified Parkinson's Disease Rating Scale


Enrollment: 106
Actual Study Start Date: March 3, 2016
Estimated Study Completion Date: December 17, 2018
Estimated Primary Completion Date: December 17, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo
Experimental: PF-06649751 low dose (1 mg QD)
PF-06649751 low dose level (1 mg QD)
Drug: PF-06649751 low dose (1 mg QD)
PF-06649751 low dose (1 mg QD)
Experimental: PF-06649751 middle dose 1 (3 mg QD)
PF-06649751 lower middle dose 1 (3 mg QD)
Drug: PF-06649751 middle dose 1 (3 mg QD)
PF-06649751 lower middle dose 1 (3 mg QD)
Experimental: PF-06649751 middle dose 2 (7 mg QD)
PF-06649751 higher middle dose 2 (7 mg QD)
Drug: PF-06649751 middle dose 2 (7 mg QD)
PF-06649751higher middle dose 2 (7 mg QD)
Experimental: PF-06649751 high dose (15 mg QD)
PF-06649751 high dose (15 mg QD)
Drug: PF-06649751 high dose (15 mg QD)
PF-06649751 high dose (15 mg QD)

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02687542


  Show 68 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02687542     History of Changes
Other Study ID Numbers: B7601003
2015-004912-39 ( EudraCT Number )
A-ROSE PD ( Other Identifier: Alias Study Number )
A-ROSE ( Other Identifier: Alias Study Number )
First Submitted: January 29, 2016
First Posted: February 22, 2016
Last Update Posted: October 9, 2017
Last Verified: October 2017

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

Keywords provided by Pfizer:
Parkinson Disease
Motor Fluctuation

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