CompletedPhase 1

PF 06412562 in Subjects With Advanced Stage Parkinson's Disease

United States8 participantsStarted 2018-09-24

Plain-language summary

The purpose of this study is to test the safety and tolerability of the investigational drug PF-06412562 compared to the current medical standard of care medication for Parkinson's disease, carbidopa/levodopa. This research also is being done to find out if the investigational drug PF-06412562 can help improve the motor (movement) function, alertness, and cognitive (thinking) skills of people who are considered to be in the advanced-stage of Parkinson's disease. In this study, PF06412562 is 'investigational,' which means that it is experimental and has not been approved by the US Food and Drug Administration (FDA), but can be used in clinical research studies such as this one.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and tolerability of PF-06412562 assessed by blood sample results

Timeframe: Day 1

Safety and tolerability of PF-06412562 assessed by blood sample results

Timeframe: Day 1

Safety and tolerability of PF-06412562 assessed by blood sample results

Timeframe: Day 1

Safety and tolerability of PF-06412562 assessed by blood sample results

Timeframe: Day 1

Safety and tolerability of PF-06412562 assessed by blood sample results

Timeframe: Day 1

Safety and tolerability of PF-06412562 assessed by blood sample results

Timeframe: Day 1

Safety and tolerability of PF-06412562 assessed by blood sample results

Timeframe: Day 4

Trial details

NCT IDNCT03665454

SponsorMilton S. Hershey Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-03-21

View on ClinicalTrials.gov More Parkinson Disease trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Safety and tolerability of PF-06412562 assessed by blood sample results

Timeframe: Day 1

Safety and tolerability of PF-06412562 assessed by blood sample results

Timeframe: Day 1

Safety and tolerability of PF-06412562 assessed by blood sample results

Timeframe: Day 1

Safety and tolerability of PF-06412562 assessed by blood sample results

Timeframe: Day 1

Safety and tolerability of PF-06412562 assessed by blood sample results

Timeframe: Day 1

Safety and tolerability of PF-06412562 assessed by blood sample results

Timeframe: Day 1

Safety and tolerability of PF-06412562 assessed by blood sample results

Timeframe: Day 4