Parkinson's Disease With Motor Fluctuations Clinical Trial
Official title:
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.
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