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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03185481
• Date of registration: 09/06/2017
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor Fluctuations
• Scientific 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
• Date of first enrolment: July 6, 2017
• Target sample size: 5
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03185481
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 40 Years
Age maximum: 87 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease With Motor Fluctuations

Intervention(s)

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

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

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

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: 1 mg QD to 15 mg QD PF-06649751

Drug: 15 mg QD PF-06649751

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

Primary Outcome(s)

Number of Participants With Clinically Significant Findings in Physical Examination [Time Frame: Baseline to last visit after termination (up to approximately 3 months)]

Number of Participants With Treatment-Emergent Adverse Events (All Causalities) [Time Frame: Baseline to last visit after termination (up to approximately 3 months)]

Number of Participants With Vital Signs Data of Orthostatic Hypotension Meeting Pre-defined Criteria [Time Frame: Baseline to last visit after termination (up to approximately 3 months)]

Number of Participants With Electrocardiogram Data Meeting Pre-defined Criteria [Time Frame: Baseline to last visit after termination (up to approximately 3 months)]

Number of Participants With Vital Signs Data Meeting Pre-defined Criteria [Time Frame: Baseline to last visit after termination (up to approximately 3 months)]

Number of Participants With Worsening Suicidality and New Onset Suicidality [Time Frame: Baseline to last visit after termination (up to approximately 3 months)]

Number of Participants With Benzodiazepine Discontinuation Symptoms Based on Physician Withdrawal Checklist (PWC-20) [Time Frame: At last visit]

Number of Participants With Treatment-Emergent Adverse Events (Treatment Related) [Time Frame: Baseline to last visit after termination (up to approximately 3 months)]

Number of Participants With Abnormalities in Laboratory Test (Without Regard to Baseline Abnormality) [Time Frame: Baseline to last visit after termination(up to approximately 3 months)]

Number of Participants With Clinically Significant Findings in Neurological Examination [Time Frame: Baseline to last visit after termination (up to approximately 3 months)]

Secondary Outcome(s)

Change From Baseline for Hauser Participant Diary Data in Daily ON Time With Troublesome Dyskinesia [Time Frame: Baseline, Day 21 and Day 35]

Change From Baseline for Hauser Participant Diary Data in Daily OFF Time [Time Frame: Baseline, Day 21 and Day 35]

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 [Time Frame: Baseline to last visit after termination (up to approximately 3 months)]

Change From Baseline for Hauser Participant Diary Data in Daily ON Time Without Troublesome Dyskinesia [Time Frame: Baseline, Day 21 and Day 35]

Secondary ID(s)

2017-000128-81

B7601017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 12/04/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03185481