Clinical trial NCT03185481
Conditions: Parkinson's Disease With Motor Fluctuations
Keywords: Parkinson's Disease Motor Fluctuations D1 partial agonist
Sponsor: Pfizer
Start date: 2017-07-06; Completion date: 2017-10-25
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: Up titration from 1 mg QD to 15 mg QD PF-06649751 arm 2: Up titration from 3 mg QD to 15 mg QD PF-06649751 arm 3: Up titration from 7 mg QD to 15 mg QD PF-06649751 arm 4: 15 mg QD PF-06649751 remains at 15 mg QD PF-06649751 arm 5: Up titration from 1 to 7 mg QD PF-06649751 if de-escalated in parent study arm 6: Up titration from 3 to 7 mg QD PF-06649751 if de-escalated in parent study arm 7: 7 mg QD remains at 7 mg QD PF-06649751 if de-escalated in parent study arm 8: 15 mg QD de-escalated to 7 mg QD in parent study B7601003 remain at 15 mg QD PF-06649751
Interventions: intervention 1: 1 mg QD to 15 mg QD PF-06649751 intervention 2: 3 mg QD to 15 mg QD PF-06649751 intervention 3: 7 mg QD to 15 mg QD PF-06649751 intervention 4: 15 mg QD PF-06649751 intervention 5: 1 mg QD to 7 mg QD PF-06649751 (if de-escalated in parent study) intervention 6: 3 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study) intervention 7: 7 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study) intervention 8: 15 mg QD de-escalated to 7 mg QD PF-06649751 in parent study remain at 7 mg QD
Intervention descriptions: intervention 1: Up titration from 1 mg QD to 15 mg QD PF-06649751 intervention 2: Up titration from 3 mg QD to 15 mg QD PF-06649751 intervention 3: Up titration from 7 mg QD to 15 mg QD PF-06649751 intervention 4: 15 mg QD PF-06649751 remaining at 15 mg QD PF-06649751 intervention 5: 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 intervention 6: 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 intervention 7: 7 mg QD to remain at 7 mg QD PF-06649751 for subjects who were blindly de-escalated in parent study intervention 8: 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

Protocol documents:
Prot_000.pdf: 
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