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

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NCT02687542

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Study Location
Xenoscience, Inc
Phoenix, Arizona, 85004, United States
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Parkinson Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-85 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Tablets
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
Yes only
Duration
The time commitment for participation in the study.
Follow up: Estimated 4 weeks
Screening: Estimated 1 weeks
Treatment: Estimated 15 weeks
Site Visits
Follow up: 1 visits
Screening: Up to 2 visits
Treatment: At least 11 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Possible
Trial Procedures
Blood test
Electrocardiogram (ECG)
Physical examination
Questionnaire
Keeping a diary
Urine test
Vital signs and measurements
Other

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Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 20, 2017)		108
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2016)		198
Actual Study Completion Date  ICMJE November 10, 2017
Actual Primary Completion Date November 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Germany,   Japan,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02687542
Other Study ID Numbers  ICMJE B7601003
2015-004912-39 ( EudraCT Number )
A-ROSE PD ( Other Identifier: Alias Study Number )
A-ROSE ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2020

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