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Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease

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NCT02847650

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
St Joseph's Hospital and Medical Center, Barrow Neurology Clinics
Phoenix, Arizona, 85013 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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
45-80 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

- Clinical diagnosis of Parkinson's disease.

- Parkinson's Disease Hoehn & Yahr Stage I-III inclusive

- Treatment naïve or history of prior incidental treatment with dopaminergic agents for
no more than 28 days

- 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

- History or presence of atypical Parkinsonian syndrome.

- Severe acute or chronic medical or psychiatric condition or cognitive impairment 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.

NCT02847650
Pfizer
Terminated
Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease

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Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease
A 15-week, Phase 2, Double Blind, Randomized, Placebo-controlled, Flexible Dose Study To Investigate The Efficacy, Safety And Tolerability Of Pf-06649751 In Subjects With Early Stage Parkinson's Disease
The purpose of this study is to evaluate the efficacy, safety and tolerability of PF-06649751 in Parkinson's disease patients at early stage of the disease.
The B7601011 study has a randomized, double-blind, placebo-controlled parallel group design. Approximately 88 subjects will be randomized to 2 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
    Other Name: oral tablet once daily
  • Drug: PF-06649751
    Other Name: flexible dose oral tablet once daily
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-06649751
    Intervention: Drug: PF-06649751
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
57
February 3, 2018
January 6, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Females of non-childbearing potential and/or male subjects
  • Clinical diagnosis of Parkinson's disease.
  • Parkinson's Disease Hoehn & Yahr Stage I-III inclusive
  • Treatment naïve or history of prior incidental treatment with dopaminergic agents for no more than 28 days
  • Able to refrain from any Parkinson's disease medication not permitted by the protocol.

Exclusion Criteria:

  • History or presence of atypical Parkinsonian syndrome.
  • Severe acute or chronic medical or psychiatric condition or cognitive impairment 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
45 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Israel,   United States
 
 
NCT02847650
B7601011
2016-001575-71 ( EudraCT 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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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