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PF-06669571 In Subjects With Idiopathic Parkinson's Disease

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NCT02565628

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511 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.
Idiopathic Parkinson's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0+
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects must have a clinical diagnosis of idiopathic Parkinson's disease and presence
of at least 2 out of 3 cardinal characteristics (tremor, rigidity and/or
bradykinesia).

- Must be Hoehn & Yahr Stage II-III inclusive and experiencing motor fluctuations in the
form of end-of-dose wearing off during the morning hours or early morning akinesia.

- Subjects should be able to recognize their "wearing off" symptoms and verify that they
usually improve after their next dose of Parkinson's disease medication. Subjects
should be able to recognize drug-induced dyskinesias and verify whether or not they
are troublesome.

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

- History or clinical features consistent with an atypical parkinsonian syndrome, (for
example: ataxia, dystonia, clinically significant orthostatic hypotension.

NCT02565628
Pfizer
Completed
PF-06669571 In Subjects With Idiopathic Parkinson's Disease

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PF-06669571 In Subjects With Idiopathic Parkinson's Disease
A Phase 1b, Double Blind, Sponsor Open, Randomized, Parallel, Group Multiple Dose Study Examining The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06669571 In Subjects With Idiopathic Parkinson's Disease.
This study is designed to assess safety, tolerability and pharmacokinetic data for multiple doses of PF-06669571 in subjects with idiopathic Parkinson's disease. In addition, this study will assess whether PF-06669571 is able to demonstrate superior efficacy compared with placebo in the treatment of the motor symptoms of idiopathic Parkinson's disease.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Idiopathic Parkinson's Disease
  • Drug: PF-06669571
    1 milligram (mg) QD for 3 days followed by 3 mg QD for 4 days
  • Drug: Placebo
    Placebo
  • Experimental: PF-06669571
    Once daily (QD) for 7 days
    Intervention: Drug: PF-06669571
  • Placebo Comparator: Placebo
    QD for 7 days
    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
20
May 13, 2016
May 13, 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects must have a clinical diagnosis of idiopathic Parkinson's disease and presence of at least 2 out of 3 cardinal characteristics (tremor, rigidity and/or bradykinesia).
  • Must be Hoehn & Yahr Stage II-III inclusive and experiencing motor fluctuations in the form of end-of-dose wearing off during the morning hours or early morning akinesia.
  • Subjects should be able to recognize their "wearing off" symptoms and verify that they usually improve after their next dose of Parkinson's disease medication. Subjects should be able to recognize drug-induced dyskinesias and verify whether or not they are troublesome.

Exclusion Criteria:

- History or clinical features consistent with an atypical parkinsonian syndrome, (for example: ataxia, dystonia, clinically significant orthostatic hypotension.
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02565628
B7821002
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 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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