Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02847650
• Date of registration: 25/07/2016
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the Disease
• Scientific title: A 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON'S DISEASE
• Date of first enrolment: October 17, 2016
• Target sample size: 57
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02847650
• Study type: Interventional
• Study design: Allocation: Randomized. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

France, Germany, Israel, United States

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Females of non-childbearing potential and/or male subjects

- Clinical diagnosis of Parkinson's disease.

- Parkinson's Disease Hoehn & Yahr Stage I-III inclusive

- Treatment naïve or history of prior incidental treatment with dopaminergic agents for
no more than 28 days

- Able to refrain from any Parkinson's disease medication not permitted by the protocol.

Exclusion Criteria:

- History or presence of atypical Parkinsonian syndrome.

- Severe acute or chronic medical or psychiatric condition or cognitive impairment or
laboratory abnormality.

- Any condition possibly affecting drug absorption.

- Participation in other studies involving investigational drug(s), or treatment with
any investigational drug within 30 days.



Age minimum: 45 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: PF-06649751

Drug: Placebo

Primary Outcome(s)

Change From Baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Total Score at Week 15 [Time Frame: Baseline (Day -1/randomization), Week 15]

Secondary Outcome(s)

Number of Participants Meeting the Categorical Summarization Criteria for Electrocardiogram (ECG) Parameters [Time Frame: Baseline (Day -1/randomization) up to Day 119 follow-up visit]

Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) [Time Frame: Baseline (Day -1/randomization) up to Day 119 follow-up visit]

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: From first dose of study treatment up to 28 days after last dose (up to Day 133)]

Number of Participants With Worsening and New Onset Suicidality as Assessed by Columbia Suicide Severity Rating Scale (C-SSRS) [Time Frame: Baseline (Day -1/randomization) up to Day 119 follow-up visit]

Total Physician Withdrawal Checklist (PWC-20) Score [Time Frame: Day 119]

Change From Baseline in Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease - Rating Scale (QUIP-RS) Total Score at Days 35, 63, and 105 [Time Frame: Baseline (Day -1 or randomization); Days 35, 63, 105]

Number of Participants With Vital Signs Data Meeting Categorical Summarization and Orthostatic Hypotension Criteria [Time Frame: Baseline (Day -1/randomization) up to Day 119 follow-up visit]

Secondary ID(s)

2016-001575-71

B7601011

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/01/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02847650