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

NCT03185481 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2019-04-12

Study results available
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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.

Conditions

  • Parkinson's Disease With Motor Fluctuations

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
87 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-06
Primary Completion
2017-10-24
Completion
2017-10-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03185481 on ClinicalTrials.gov