Clinical trial NCT03185481: Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Parkinson's Disease With Motor Fluctuations
Keywords: Parkinson's Disease
Motor Fluctuations
D1 partial agonist
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2017-06-14
Enrollment: 5
Sex: ALL
Minimum age (years): 40
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (All Causalities)
timeFrame: Baseline to last visit after termination (up to approximately 3 months)
measure: Number of Participants With Treatment-Emergent Adverse Events (Treatment Related)
timeFrame: Baseline to last visit after termination (up to approximately 3 months)
measure: Number of Participants With Clinically Significant Findings in Physical Examination
timeFrame: Baseline to last visit after termination (up to approximately 3 months)
measure: Number of Participants With Clinically Significant Findings in Neurological Examination
timeFrame: Baseline to last visit after termination (up to approximately 3 months)
measure: Number of Participants With Abnormalities in Laboratory Test (Without Regard to Baseline Abnormality)
timeFrame: Baseline to last visit after termination(up to approximately 3 months)
measure: Number of Participants With Vital Signs Data Meeting Pre-defined Criteria
timeFrame: Baseline to last visit after termination (up to approximately 3 months)
measure: Number of Participants With Vital Signs Data of Orthostatic Hypotension Meeting Pre-defined Criteria
timeFrame: Baseline to last visit after termination (up to approximately 3 months)
measure: Number of Participants With Electrocardiogram Data Meeting Pre-defined Criteria
timeFrame: Baseline to last visit after termination (up to approximately 3 months)
measure: Number of Participants With Worsening Suicidality and New Onset Suicidality
timeFrame: Baseline to last visit after termination (up to approximately 3 months)
measure: Number of Participants With Benzodiazepine Discontinuation Symptoms Based on Physician Withdrawal Checklist (PWC-20)
timeFrame: At last visit
Secondary outcomes:
measure: Change From Baseline for Hauser Participant Diary Data in Daily OFF Time
timeFrame: Baseline, Day 21 and Day 35
measure: Change From Baseline for Hauser Participant Diary Data in Daily ON Time With Troublesome Dyskinesia
timeFrame: Baseline, Day 21 and Day 35
measure: Change From Baseline for Hauser Participant Diary Data in Daily ON Time Without Troublesome Dyskinesia
timeFrame: Baseline, Day 21 and Day 35
measure: Change From Baseline in Movement Disorder Society Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I, II, III, IV, and Total Score
timeFrame: Baseline to last visit after termination (up to approximately 3 months)
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Fairfield
country: United States
facility: Associated Neurologists of Southern CT, PC
state: Connecticut
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Marlton
country: United States
facility: Pharmaceutical Research Associates, Inc.
state: New Jersey
city: Toledo
country: United States
facility: University of Toledo, Gardner-McMaster Parkinson Center
state: Ohio
city: Toledo
country: United States
facility: University of Toledo, Investigational Drug Services
state: Ohio
city: Tulsa
country: United States
facility: The Movement Disorder Clinic of Oklahoma
state: Oklahoma
city: Kirkland
country: United States
facility: Booth Gardner Parkinson's Care Center
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: