PF 06412562 in Subjects With Advanced Stage Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-24

Study Completion Date

2019-04-21

Brief Summary

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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.

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Detailed Description

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The investigators are conducting a randomized, double-blind, carbidopa/levodopa-controlled crossover safety, tolerability, and efficacy study of the investigational compound, PF-06412562, in advanced Parkinson's patients. The primary 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, in these patients. This secondary purpose of this research is 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. This study will inform the field as to whether PF-06412562 is safe and well-tolerated in advanced Parkinson's patients, and also may provide preliminary data on its efficacy in several domains.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Subjects will participate in study for 2 consecutive weeks. Days 2-3 of Week 1, they will be blindly and randomly assigned to one of two treatment arms (study drug PF-06412562 or standard of care carbidopa/levodopa). Whichever treatment arm they did not receive during Week 1, they will receive during Days 2-3 of Week 2.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Investigational Drug Services, which is the investigational drug pharmacy at Hershey Medical Center, will be preparing and dispensing the drug. They will be the only party that is unblinded. Pfizer will provide placebo pills that are identical in appearance to the PF-06412562 study drug. The standard of care treatment, carbidopa/levodopa, is different in appearance to PF-06412562 and its corresponding matching placebo. In order to blind for this, Investigational Drug Services will encapsulate the carbidopa/levodopa pills. Thus, subjects may receive either an encapsulated carbidopa/levodopa pill or an empty non-active capsule, depending on the treatment arm and dosing they are scheduled to receive.

Study Groups

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PF-06412562

Subjects will receive 25 mg of PF-06412562 twice daily on study Days 2 and 3, along with placebo carbidopa/levodopa dosed at these times. Additional carbidopa/levodopa placebo capsules also will be administered according to the subject's home regimen.

Group Type EXPERIMENTAL

PF-06412562

Intervention Type DRUG

PF-06412562 is a dopamine agonist developed by Pfizer Inc. into a tablet form for oral usage. It will be provided as 5 mg tablets. Thus, to administer the 25 mg dose, 5 x 5 mg tablets will be given; and to administer the 20 mg dose, 4 x 5 mg tablets will be administered.

Standard of Care carbidopa/levodopa

Subjects will take placebo tablets for the PF-06412562 twice daily on study Days 2 and 3, along with active carbidopa/levodopa (25/100 mg) administered at these times. Additional active carbidopa/levodopa capsules also will be administered according to the subject's home regimen.

Group Type ACTIVE_COMPARATOR

Standard of Care Placebo

Intervention Type DRUG

25/100 mg tablet(s) of carbidopa/levodopa will be encapsulated and administered according to the subject's home regimen.

Interventions

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PF-06412562

PF-06412562 is a dopamine agonist developed by Pfizer Inc. into a tablet form for oral usage. It will be provided as 5 mg tablets. Thus, to administer the 25 mg dose, 5 x 5 mg tablets will be given; and to administer the 20 mg dose, 4 x 5 mg tablets will be administered.

Intervention Type DRUG

Standard of Care Placebo

25/100 mg tablet(s) of carbidopa/levodopa will be encapsulated and administered according to the subject's home regimen.

Intervention Type DRUG

Other Intervention Names

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Sinemet

Eligibility Criteria

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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)

Eligible Sex

ALL

Accepts Healthy Volunteers

No