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Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations

Last updated on January 23, 2020

FOR MORE INFORMATION
Study Location
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Parkinson's Disease With Motor Fluctuations
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-87 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Having successfully completed parent study B7601003.

- Clinical diagnosis of Parkinson's disease.

- 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

- Female of childbearing potential.

- Severe acute or chronic medical or psychiatric condition or laboratory abnormality.

- Participation in other studies involving investigational drug(s), or treatment with
any investigational drug within 30 days.

NCT03185481
Pfizer
Recruiting
Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations

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Parkinson's Disease With Motor Fluctuations
NCT03185481
All Genders
40+
Years
Multiple Sites
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations
Official Title  ICMJE A PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE
Brief Summary The purpose of this study is to evaluate the long term safety and tolerability of PF-06649751 in Parkinson's disease patients who experience motor-fluctuations.
Detailed Description

This is an open label study evaluating the long term safety and tolerability of PF-06649751 in Parkinson's disease patients who experience motor-fluctuations. Subjects who completed Ph2 study B7601003 will be randomized to one of 4 treatment groups (15 mg QD, 7 mg QD, 3 mg QD, or 1 mg QD group) depending on the treatment received in B7601003 and titrated up to 15 mg QD over a 3 week period, as appropriate. All subjects who were blindly down-titrated during the B7601003 study will remain at/or be titrated to 7 mg QD only and remain at that dose for the rest of the B7601017 study in order to protect the blind for the prior study. Subjects who successfully titrate to 15 mg QD will enter the Adjustment Period at that dose.

Subjects who cannot tolerate 15 mg QD at any time during the study will be allowed to down-titrate to 7 mg QD (but not lower) and will stay at that dose for the rest of the study.

Subjects who cannot remain at a stable dose (7 mg or 15 mg QD) will be discontinued.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Depending on the actual treatment the subject received in B7601003, subjects will be randomized to one of 4 treatment groups (15 mg QD, 7 mg QD, 3 mg QD, or 1 mg QD group) and titrated up to 15 mg QD over a 3 week period, as appropriate.

All subjects who were blindly down-titrated during the parent study (B7601003) will remain at/or be titrated to 7 mg QD only and remain at that dose for the rest of the B7601017 study in order to protect the blind for the parent study. Subjects who successfully titrate to 15 mg QD will enter the Adjustment Period at that dose. Subjects who cannot tolerate 15 mg QD at any time during the study will be allowed to down-titrate to 7 mg QD (but not lower) and will stay at that dose for the rest of the study. Subjects who cannot remain at a stable dose (7 mg or 15 mg QD) will be discontinued.

Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:

During the titration phase, the allocation to treatment will be double blind to protect the blind of the parent study (B7601003). After completing the titration phase, the treatment assignment becomes open label.

Primary Purpose: Treatment

Condition  ICMJE Parkinson's Disease With Motor Fluctuations
Intervention  ICMJE
  • Drug: 1 mg QD to 15 mg QD PF-06649751
    Up titration from 1 mg QD to 15 mg QD PF-06649751
  • Drug: 3 mg QD to 15 mg QD PF-06649751
    Up titration from 3 mg QD to 15 mg QD PF-06649751
  • Drug: 7 mg QD to 15 mg QD PF-06649751
    Up titration from 7 mg QD to 15 mg QD PF-06649751
  • Drug: 15 mg QD PF-06649751
    15 mg QD PF-06649751 remaining at 15 mg QD PF-06649751
  • Drug: 1 mg QD to 7 mg QD PF-06649751 (if de-escalated in parent study)
    Up titration from 1 mg QD to 7 mg QD PF-06649751 for subject at 1 mg QD who were blindly de-escalated in the parent study
  • Drug: 3 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study)
    Up titration from 3 mg QD to 7 mg QD PF-06649751 for 3 mg QD subjects who were blindly de-escalated in parent study
  • Drug: 7 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study)
    7 mg QD to remain at 7 mg QD PF-06649751 for subjects who were blindly de-escalated in parent study
  • Drug: 15 mg QD de-escalated to 7 mg QD PF-06649751 in parent study remain at 7 mg QD
    7mg QD PF-06649751 for subjects assigned to 15 mg QD who were blindly de-escalated to 7 mg QD PF-06649751 in parent study
Study Arms  ICMJE
  • Experimental: 1 mg QD to 15 mg QD PF-06649751
    Up titration from 1 mg QD to 15 mg QD PF-06649751
    Intervention: Drug: 1 mg QD to 15 mg QD PF-06649751
  • Experimental: 3 mg QD to 15 mg QD PF-06649751
    Up titration from 3 mg QD to 15 mg QD PF-06649751
    Intervention: Drug: 3 mg QD to 15 mg QD PF-06649751
  • Experimental: 7 mg QD to 15 mg QD PF-06649751
    Up titration from 7 mg QD to 15 mg QD PF-06649751
    Intervention: Drug: 7 mg QD to 15 mg QD PF-06649751
  • Experimental: 15 mg QD PF-06649751
    15 mg QD PF-06649751 remains at 15 mg QD PF-06649751
    Intervention: Drug: 15 mg QD PF-06649751
  • Experimental: 1 mg to 7 mg QD PF-06649751
    Up titration from 1 to 7 mg QD PF-06649751 if de-escalated in parent study
    Intervention: Drug: 1 mg QD to 7 mg QD PF-06649751 (if de-escalated in parent study)
  • Experimental: 3 mg QD to 7 mg QD PF-06649751
    Up titration from 3 to 7 mg QD PF-06649751 if de-escalated in parent study
    Intervention: Drug: 3 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study)
  • Experimental: 7 mg QD to 7 mg QD PF-06649751
    7 mg QD remains at 7 mg QD PF-06649751 if de-escalated in parent study
    Intervention: Drug: 7 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study)
  • Experimental: 15 mg to 7 mg QD PF-06649751
    15 mg QD de-escalated to 7 mg QD in parent study B7601003 remain at 15 mg QD PF-06649751
    Intervention: Drug: 15 mg QD de-escalated to 7 mg QD PF-06649751 in parent study remain at 7 mg QD
Publications * Not Provided


*   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: December 1, 2017)
5
Original Estimated Enrollment  ICMJE
 (submitted: June 9, 2017)
198
Actual Study Completion Date  ICMJE October 25, 2017
Actual Primary Completion Date October 24, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Having successfully completed parent study B7601003.
  • Clinical diagnosis of Parkinson's disease.
  • Able to refrain from any Parkinson's disease medication not permitted by the protocol.

Exclusion Criteria:

  • Female of childbearing potential.
  • Severe acute or chronic medical or psychiatric condition or laboratory abnormality.
  • 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 40 Years to 87 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03185481
Other Study ID Numbers  ICMJE B7601017
2017-000128-81 ( 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/da....
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2019

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 the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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