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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
January 29, 2016
February 22, 2016
October 9, 2017
March 3, 2016
December 17, 2018   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT02687542 on ClinicalTrials.gov Archive Site
  • % 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
Same as current
Not Provided
Not Provided
 
Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations
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
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.
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.
Interventional
Phase 2
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Parkinson Disease
  • Drug: Placebo
    Placebo
  • Drug: PF-06649751 low dose (1 mg QD)
    PF-06649751 low dose (1 mg QD)
  • Drug: PF-06649751 middle dose 1 (3 mg QD)
    PF-06649751 lower middle dose 1 (3 mg QD)
  • Drug: PF-06649751 middle dose 2 (7 mg QD)
    PF-06649751higher middle dose 2 (7 mg QD)
  • Drug: PF-06649751 high dose (15 mg QD)
    PF-06649751 high dose (15 mg QD)
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-06649751 low dose (1 mg QD)
    PF-06649751 low dose level (1 mg QD)
    Intervention: Drug: 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)
    Intervention: Drug: PF-06649751 middle dose 1 (3 mg QD)
  • Experimental: PF-06649751 middle dose 2 (7 mg QD)
    PF-06649751 higher middle dose 2 (7 mg QD)
    Intervention: Drug: PF-06649751 middle dose 2 (7 mg QD)
  • Experimental: PF-06649751 high dose (15 mg QD)
    PF-06649751 high dose (15 mg QD)
    Intervention: Drug: PF-06649751 high dose (15 mg QD)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
106
December 17, 2018
December 17, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
40 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   France,   Germany,   Japan,   Spain,   United States
 
 
NCT02687542
B7601003
2015-004912-39 ( EudraCT Number )
A-ROSE PD ( Other Identifier: Alias Study Number )
A-ROSE ( Other Identifier: Alias Study Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP