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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Parkinson's Disease With Motor Fluctuations

Treatments: Drug: 15 mg QD PF-06649751; Drug: 3 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study); Drug: 3 mg QD to 15 mg QD PF-06649751; Drug: 1 mg QD to 15 mg QD PF-06649751; Drug: 7 mg QD to 15 mg QD PF-06649751; Drug: 1 mg QD to 7 mg QD PF-06649751 (if 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; Drug: 7 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03185481

B7601017

2017-000128-81 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 40 to 87 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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5 participants in 8 patient groups

1 mg QD to 15 mg QD PF-06649751

Experimental group

Description:

Up titration from 1 mg QD to 15 mg QD PF-06649751

Treatment:

Drug: 1 mg QD to 15 mg QD PF-06649751

3 mg QD to 15 mg QD PF-06649751

Experimental group

Description:

Up titration from 3 mg QD to 15 mg QD PF-06649751

Treatment:

Drug: 3 mg QD to 15 mg QD PF-06649751

7 mg QD to 15 mg QD PF-06649751

Experimental group

Description:

Up titration from 7 mg QD to 15 mg QD PF-06649751

Treatment:

Drug: 7 mg QD to 15 mg QD PF-06649751

15 mg QD PF-06649751

Experimental group

Description:

15 mg QD PF-06649751 remains at 15 mg QD PF-06649751

Treatment:

Drug: 15 mg QD PF-06649751

1 mg to 7 mg QD PF-06649751

Experimental group

Description:

Up titration from 1 to 7 mg QD PF-06649751 if de-escalated in parent study

Treatment:

Drug: 1 mg QD to 7 mg QD PF-06649751 (if de-escalated in parent study)

3 mg QD to 7 mg QD PF-06649751

Experimental group

Description:

Up titration from 3 to 7 mg QD PF-06649751 if de-escalated in parent study

Treatment:

Drug: 3 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study)

7 mg QD to 7 mg QD PF-06649751

Experimental group

Description:

7 mg QD remains at 7 mg QD PF-06649751 if de-escalated in parent study

Treatment:

Drug: 7 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study)

15 mg to 7 mg QD PF-06649751

Experimental group

Description:

15 mg QD de-escalated to 7 mg QD in parent study B7601003 remain at 15 mg QD PF-06649751

Treatment:

Drug: 15 mg QD de-escalated to 7 mg QD PF-06649751 in parent study remain at 7 mg QD