Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations
Condition: Parkinson's Disease With Motor Fluctuations
MeSH terms: Parkinson Disease
Intervention: 1 mg QD to 15 mg QD PF-06649751; 3 mg QD to 15 mg QD PF-06649751; 7 mg QD to 15 mg QD PF-06649751; 15 mg QD PF-06649751; 1 mg QD to 7 mg QD PF-06649751 (if de-escalated in parent study); 3 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study); 7 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study); 15 mg QD de-escalated to 7 mg QD PF-06649751 in parent study remain at 7 mg QD
Intervention description: Up titration from 1 mg QD to 15 mg QD PF-06649751; Up titration from 3 mg QD to 15 mg QD PF-06649751; Up titration from 7 mg QD to 15 mg QD PF-06649751; 15 mg QD PF-06649751 remaining at 15 mg QD PF-06649751; 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; 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; 7 mg QD to remain at 7 mg QD PF-06649751 for subjects who were blindly de-escalated in parent study; 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
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.
Enrollment: 5.0
Sex: All
Minimum age: 40 Years
Maximum age: 87 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; Motor Fluctuations; D1 partial agonist

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.
    

Eligibility criteria:

        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.