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Efficacy, Safety And Tolerability Study In Subjects With Parkinson's Disease

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Aventura, Florida, 33180 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Parkinson's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
30-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female subjects with a diagnosis of idiopathic Parkinson's disease.

- Daily L-dopa dose between 300 and 1200 mg.

- MBRS score >1.

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

- Surgical intervention for Parkinson's disease.

- History of troublesome dyskinesias.

- Any significant AXIS I psychiatric disease.

NCT02006290
Pfizer
Completed
Efficacy, Safety And Tolerability Study In Subjects With Parkinson's Disease

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Efficacy, Safety And Tolerability Study In Subjects With Parkinson's Disease
A Phase 1b, Randomized, Subject And Investigator-Blinded, Sponsor-Open, Placebo Controlled, Cross-Over Efficacy, Safety And Tolerability Study Of Single Oral Split Dose Administration Of PF-06412562 In Subjects With Parkinson's Disease
The B7441003 study will assess PF-06412562 for motor benefit in Parkinson's disease subjects. Safety, tolerability and PK of PF-06412562 in Parkinson's disease subjects will also be evaluated.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Parkinson's Disease
  • Drug: PF-06412562
    single oral split dose 30+20 mg QD
  • Drug: Placebo
    tablet, matching placebo, QD
  • Experimental: 1
    Intervention: Drug: PF-06412562
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
August 2014
August 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects with a diagnosis of idiopathic Parkinson's disease.
  • Daily L-dopa dose between 300 and 1200 mg.
  • MBRS score >1.

Exclusion Criteria:

  • Surgical intervention for Parkinson's disease.
  • History of troublesome dyskinesias.
  • Any significant AXIS I psychiatric disease.
Sexes Eligible for Study: All
30 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02006290
B7441003
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2015

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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