PF 06412562 in Subjects With Advanced Stage Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03665454
• Date of registration: 01/08/2018
• Prospective Registration: Yes
• Primary sponsor: Milton S. Hershey Medical Center
• Public title: PF 06412562 in Subjects With Advanced Stage Parkinson's Disease
• Scientific title: A Phase Ib Safety, Tolerability, and Efficacy Study of Two Days of Oral Split Dose (25/20 mg) Administration of PF 06412562 in Subjects With Advanced Stage Parkinson's Disease
• Date of first enrolment: September 24, 2018
• Target sample size: 8
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03665454
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Xuemei Huang, MD, PhD
• Affiliation: Milton S. Hershey Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of classic PD with history of clinically meaningful response to levodopa

- Disease duration >15 years since diagnosis

- Hoehn & Yahr stage >IV "on" or "off" levodopa

- Consent signed by subject, if possible

- If subject is cognitively impaired, consent signed by power of attorney or legally
authorized subject representative

- Assent from the study subject, if possible

- Stable dose of all medications for 60 days prior to Day 1 of first week of study

Exclusion Criteria:

- Atypical parkinsonian syndrome (e.g., never responded to levodopa, and/or atypical
signs)

- Acute or unstable medical condition such as heart disease, kidney and liver failure

- History of HIV, hepatitis B and C

- Use of moderate to strong CYP 3A4 modulators (see both inhibitors and inducers in
Appendix BB)



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Standard of Care Placebo

Drug: PF-06412562

Primary Outcome(s)

Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function [Time Frame: X3 on Days 2 over 15 min each time]

Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function [Time Frame: X1 on Day 1 over 15 min]

Safety and tolerability of PF-06412562 assessed by blood sample results [Time Frame: Day 1]

Safety and tolerability of PF-06412562 assessed by vital signs [Time Frame: X2 on Day 1]

Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function [Time Frame: X3 on Days 3 over 15 min each time]

Safety and tolerability of PF-06412562 assessed by vital signs [Time Frame: X2 on Day 4]

Safety and tolerability of PF-06412562 assessed by Columbia Suicide Rating [Time Frame: X1 on Day 1]

Safety and tolerability of PF-06412562 assessed by UPDRS-IV [Time Frame: X3 on Days 3]

Safety and tolerability of PF-06412562 assessed by vital signs [Time Frame: Time Frame: Vital signs: X2 on Day 1]

Safety and tolerability of PF-06412562 assessed by blood sample results [Time Frame: Day 4]

Safety and tolerability of PF-06412562 assessed by Columbia Suicide Rating [Time Frame: X1 on Day 4]

Safety and tolerability of PF-06412562 assessed by UPDRS-IV [Time Frame: X3 on Days 2]

Safety and tolerability of PF-06412562 assessed by vital signs [Time Frame: X3 on Days 2]

Safety and tolerability of PF-06412562 assessed by vital signs [Time Frame: X3 on Days 3]

Secondary Outcome(s)

Pilot data on potential efficacy of PF-06412562 compared to the standard of care treatment (i.e., carbidopa/levodopa) on overall signs and quality of life in subjects with advanced PD [Time Frame: Global Impression of Change: X3 on Days 2 and 3; Caregiver Perception of Change: X1 on Day 3]

Secondary ID(s)

9437

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pfizer