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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Xenoscience, Inc
Phoenix, Arizona, 85004 United States
Contact
1-800-718-1021
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
NCT02687542
Pfizer
Terminated
Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations

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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
Intervention Model: Parallel Assignment
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.
 
Terminated
108
November 10, 2017
November 10, 2017   (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
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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