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

Last updated on March 22, 2018

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

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

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.

Interventional
Phase 2
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

Parkinson's Disease With Motor Fluctuations
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
October 24, 2017
October 24, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
40 Years to 87 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT03185481
B7601017
2017-000128-81 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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