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

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ClinicalTrials.gov Identifier: NCT02687542
Recruitment Status : Terminated (Terminated 25Sep17 due to insufficient efficacy. Not due to safety reasons.)
First Posted : February 22, 2016
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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 or disease Intervention/treatment 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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
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
Actual Study Start Date : March 3, 2016
Actual Primary Completion Date : November 10, 2017
Actual Study Completion Date : November 10, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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 :
  1. % 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

  2. 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

  3. Safety and Tolerability including AEs, Clinical laboratory, Vital signs, and ECG. [ Time Frame: From Randomization to Week 15 ]
  4. 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")

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

  6. 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

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

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
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.

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 57 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

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 Posted: February 22, 2016    Key Record Dates
Last Update Posted: February 26, 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:
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