PF-06669571 In Subjects With Idiopathic Parkinson's Disease

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NCT02565628

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Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511, United States
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Contact
1-800-718-1021
[email protected]
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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.

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Idiopathic Parkinson's DiseasePF-06669571 In Subjects With Idiopathic Parkinson's Disease
NCT02565628
  1. New Haven, Connecticut
  2. Hallandale Beach, Florida
  3. Hollywood, Florida
  4. South Miami, Florida
  5. South Miami, Florida
  6. South Miami, Florida
  7. Atlanta, Georgia
  8. Marlton, New Jersey
  9. Cincinnati, Ohio
ALL GENDERS
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE PF-06669571 In Subjects With Idiopathic Parkinson's Disease
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Idiopathic Parkinson's Disease
Intervention  ICMJE
  • Drug: PF-06669571
    1 milligram (mg) QD for 3 days followed by 3 mg QD for 4 days
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: PF-06669571
    Once daily (QD) for 7 days
    Intervention: Drug: PF-06669571
  • Placebo Comparator: Placebo
    QD for 7 days
    Intervention: Drug: Placebo
Publications * Gurrell R, Duvvuri S, Sun P, DeMartinis N. A Phase I Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Dopamine D1 Receptor Partial Agonist, PF-06669571, in Subjects with Idiopathic Parkinson's Disease. Clin Drug Investig. 2018 Jun;38(6):509-517. doi: 10.1007/s40261-018-0632-6.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2016)		20
Original Estimated Enrollment  ICMJE
 (submitted: September 29, 2015)		19
Actual Study Completion Date  ICMJE May 13, 2016
Actual Primary Completion Date May 13, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE Child, 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02565628
Other Study ID Numbers  ICMJE B7821002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP