Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations
NCT02687542
ABOUT THIS STUDY
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Contact a representative by phone, email, or visiting the study website. Please see the references below:
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- 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.
- 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.
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Descriptive Information | |||||||
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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 |
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Study Arms ICMJE |
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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 | 108 | ||||||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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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 |