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

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NCT02847650

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Study Location
St Joseph's Hospital and Medical Center, Barrow Neurology Clinics
Phoenix, Arizona, 85013, United States
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

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1-800-718-1021

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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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description 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.
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
  • Drug: Placebo
    Other Name: oral tablet once daily
  • Drug: PF-06649751
    Other Name: flexible dose oral tablet once daily
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: PF-06649751
    Intervention: Drug: PF-06649751
Publications * Riesenberg R, Werth J, Zhang Y, Duvvuri S, Gray D. PF-06649751 efficacy and safety in early Parkinson's disease: a randomized, placebo-controlled trial. Ther Adv Neurol Disord. 2020 Mar 6;13:1756286420911296. doi: 10.1177/1756286420911296. eCollection 2020.

*   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
 (submitted: October 27, 2017)		57
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2016)		88
Actual Study Completion Date  ICMJE January 29, 2018
Actual Primary Completion Date January 29, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 45 Years to 80 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 France,   Germany,   Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02847650
Other Study ID Numbers  ICMJE B7601011
2016-001575-71 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
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 October 2020

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