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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
8
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.
25/100 mg tablet(s) of carbidopa/levodopa will be encapsulated and administered according to the subject's home regimen.
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Safety and tolerability of PF-06412562 assessed by blood sample results
NA (mmol/L), K(mmol/L), HCO3(mmol/L)
Time frame: Day 1
Safety and tolerability of PF-06412562 assessed by blood sample results
Ca (mg/dL), Mg (mg/dL), BUN( mg/dL), Creatinine (mg/dL), Bilirubin (mg/dL)
Time frame: Day 1
Safety and tolerability of PF-06412562 assessed by blood sample results
AST (U/L), ALT (U/L)
Time frame: Day 1
Safety and tolerability of PF-06412562 assessed by blood sample results
white blood cell count (K/uL), platelets (K/uL)
Time frame: Day 1
Safety and tolerability of PF-06412562 assessed by blood sample results
Hematocrit (%)
Time frame: Day 1
Safety and tolerability of PF-06412562 assessed by blood sample results
hemoglobin (g/dL)
Time frame: Day 1
Safety and tolerability of PF-06412562 assessed by blood sample results
NA (mmol/L), K(mmol/L), HCO3(mmol/L)
Time frame: Day 4
Safety and tolerability of PF-06412562 assessed by blood sample results
Ca (mg/dL), Mg (mg/dL), BUN (mg/dL), creatinine (mg/dL), bilirubin (mg/dL)
Time frame: Day 4
Safety and tolerability of PF-06412562 assessed by blood sample results
AST (U/L), ALT (U/L)
Time frame: Day 4
Safety and tolerability of PF-06412562 assessed by blood sample results
white blood cell count (K/uL), platelets (K/uL)
Time frame: Day 4
Safety and tolerability of PF-06412562 assessed by blood sample results
hematocrit (%)
Time frame: Day 4
Safety and tolerability of PF-06412562 assessed by blood sample results
hemoglobin (g/dL)
Time frame: Day 4
Safety and tolerability of PF-06412562 assessed by blood sample results
Red blood cell count (M/uL)
Time frame: Day 4
Safety and tolerability of PF-06412562 assessed by vital signs
height (inches)
Time frame: Time Frame: Vital signs: X2 on Day 1
Safety and tolerability of PF-06412562 assessed by vital signs
weight (lbs)
Time frame: X2 on Day 1
Safety and tolerability of PF-06412562 assessed by vital signs
blood pressure (mmHg)
Time frame: X2 on Day 1
Safety and tolerability of PF-06412562 assessed by vital signs
heart rate (bpm)
Time frame: X2 on Day 1
Safety and tolerability of PF-06412562 assessed by vital signs
respiratory rate (breathes/min)
Time frame: X2 on Day 1
Safety and tolerability of PF-06412562 assessed by vital signs
temperature (F)
Time frame: X2 on Day 1
Safety and tolerability of PF-06412562 assessed by vital signs
height (inches)
Time frame: X3 on Days 2
Safety and tolerability of PF-06412562 assessed by vital signs
blood pressure (mmHg)
Time frame: X3 on Days 2
Safety and tolerability of PF-06412562 assessed by vital signs
heart rate (bpm)
Time frame: X3 on Days 2
Safety and tolerability of PF-06412562 assessed by vital signs
respiratory rate (breathes/min)
Time frame: X3 on Days 2
Safety and tolerability of PF-06412562 assessed by vital signs
temperature (F)
Time frame: X3 on Days 2
Safety and tolerability of PF-06412562 assessed by vital signs
height (inches)
Time frame: X3 on Days 3
Safety and tolerability of PF-06412562 assessed by vital signs
weight (lbs)
Time frame: X3 on Days 3
Safety and tolerability of PF-06412562 assessed by vital signs
blood pressure (mmHg)
Time frame: X3 on Days 3
Safety and tolerability of PF-06412562 assessed by vital signs
heart rate (bpm)
Time frame: X3 on Days 3
Safety and tolerability of PF-06412562 assessed by vital signs
respiratory rate (breathes/min)
Time frame: X3 on Days 3
Safety and tolerability of PF-06412562 assessed by vital signs
temperature (F)
Time frame: X3 on Days 3
Safety and tolerability of PF-06412562 assessed by vital signs
height (inches)
Time frame: X2 on Day 4
Safety and tolerability of PF-06412562 assessed by vital signs
weight (lbs)
Time frame: X2 on Day 4
Safety and tolerability of PF-06412562 assessed by vital signs
blood pressure (mmHg)
Time frame: X2 on Day 4
Safety and tolerability of PF-06412562 assessed by vital signs
heart rate (bpm)
Time frame: X2 on Day 4
Safety and tolerability of PF-06412562 assessed by vital signs
respiratory rate (breathes/min)
Time frame: X2 on Day 4
Safety and tolerability of PF-06412562 assessed by vital signs
temperature (F)
Time frame: X2 on Day 4
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
Blood pressure (mmHg), cold pressor test measuring blood pressure (mmHg)
Time frame: X1 on Day 1 over 15 min
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
heart rate (beats/min), sinus arrhythmia (beats/min)
Time frame: X1 on Day 1 over 15 min
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
Blood pressure (mmHg), cold pressor test measuring blood pressure (mmHg)
Time frame: X3 on Days 2 over 15 min each time
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
heart rate (beats/min), sinus arrhythmia (beats/min)
Time frame: X3 on Days 2 over 15 min each time
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
Blood pressure (mmHg), cold pressor test measuring blood pressure (mmHg)
Time frame: X3 on Days 3 over 15 min each time
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
heart rate (beats/min), sinus arrhythmia (beats/min)
Time frame: X3 on Days 3 over 15 min each time
Safety and tolerability of PF-06412562 assessed by UPDRS-IV
UPDRS-IV (United Parkinson's Disease Rating Scale): each questions scored on scale of 0 to 4, where 0= not present, 4= severe; subscales are summed to yield a total score, min total score:0, max total score:81; higher score corresponds to increased disease severity
Time frame: X3 on Days 2
Safety and tolerability of PF-06412562 assessed by UPDRS-IV
UPDRS-IV (United Parkinson's Disease Rating Scale): each questions scored on scale of 0 to 4, where 0= not present, 4= severe; subscales are summed to yield a total score, min total score:0, max total score:81; higher score corresponds to increased disease severity
Time frame: X3 on Days 3
Safety and tolerability of PF-06412562 assessed by Columbia Suicide Rating
C-SSRS measures suicidal ideation and/or behavior. Rated from Category 1-10 with Category 1 being the least severe, and Category 10 representing the most severe, i.e. completing suicide.
Time frame: X1 on Day 1
Safety and tolerability of PF-06412562 assessed by Columbia Suicide Rating
C-SSRS measures suicidal ideation and/or behavior. Rated from Category 1-10 with Category 1 being the least severe, and Category 10 representing the most severe, i.e. completing suicide.
Time frame: X1 on Day 4
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
• Clinician Global Impression of Change score: measures change in disease symptoms per clinician's judgement. Each item rated 1-7, 1=marked improvement, 7= marked worsening; min Caregiver perception of change interview: interviews with participants' caregiver(s). Open-ended questions elicit open-ended answers about subject's behavior, appearance, cognition, etc. over the study
Time frame: Global Impression of Change: X3 on Days 2 and 3; Caregiver Perception of Change: X1 on Day 3
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.