Have you or your loved ones been diagnosed with parkinson disease?
You may be eligible to participate in a parkinson disease clinical trial.
Have you or your loved ones been diagnosed with parkinson disease? You may be eligible to participate in a parkinson disease clinical trial.
What is a clinical trial? Is participating in a clinical trial right for you? Learn more
Parkinson Disease Clinical Trial in Hershey PA
Have you or your loved ones been diagnosed with parkinson disease?
You may be eligible to participate in a parkinson disease clinical trial.
Have you or your loved ones been diagnosed with parkinson disease? You may be eligible to participate in a parkinson disease clinical trial.
Completed
Male & Female
All ages
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.
Details for the study
Brief Title
PF 06412562 in Subjects With Advanced Stage Parkinson's Disease
Official 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
Brief Summary
The purpose of this study is to test the safety and tolerability of the investigational drug<br /> PF-06412562 compared to the current medical standard of care medication for Parkinson's<br /> disease, carbidopa/levodopa. This research also is being done to find out if the<br /> investigational drug PF-06412562 can help improve the motor (movement) function, alertness,<br /> and cognitive (thinking) skills of people who are considered to be in the advanced-stage of<br /> Parkinson's disease. In this study, PF06412562 is 'investigational,' which means that it is<br /> experimental and has not been approved by the US Food and Drug Administration (FDA), but can<br /> be used in clinical research studies such as this one.
Detailed Description
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.
Treatments and/or Procedures
Standard of care placebo
25/100 mg tablet(s) of carbidopa/levodopa will be encapsulated and administered according to the subject's home regimen.
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.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
heart rate (beats/min), sinus arrhythmia (beats/min)
Primary
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
Blood pressure (mmHg), cold pressor test measuring blood pressure (mmHg)
Primary
Safety and tolerability of PF-06412562 assessed by vital signs
temperature (F)
Primary
Safety and tolerability of PF-06412562 assessed by vital signs
respiratory rate (breathes/min)
Primary
Safety and tolerability of PF-06412562 assessed by vital signs
weight (lbs)
Primary
Safety and tolerability of PF-06412562 assessed by vital signs
blood pressure (mmHg)
Primary
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
Blood pressure (mmHg), cold pressor test measuring blood pressure (mmHg)
Primary
Safety and tolerability of PF-06412562 assessed by vital signs
height (inches)
Primary
Safety and tolerability of PF-06412562 assessed by vital signs
temperature (F)
Primary
Safety and tolerability of PF-06412562 assessed by vital signs
heart rate (bpm)
Primary
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
heart rate (beats/min), sinus arrhythmia (beats/min)
Primary
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
heart rate (beats/min), sinus arrhythmia (beats/min)
Primary
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
Primary
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
Primary
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.
Primary
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.
Primary
Safety and tolerability of PF-06412562 assessed by vital signs
respiratory rate (breathes/min)
Primary
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
Blood pressure (mmHg), cold pressor test measuring blood pressure (mmHg)
Primary
Safety and tolerability of PF-06412562 assessed by vital signs
heart rate (bpm)
Primary
Safety and tolerability of PF-06412562 assessed by blood sample results
Hematocrit (%)
Primary
Safety and tolerability of PF-06412562 assessed by vital signs
weight (lbs)
Primary
Safety and tolerability of PF-06412562 assessed by blood sample results
NA (mmol/L), K(mmol/L), HCO3(mmol/L)
Primary
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)
Primary
Safety and tolerability of PF-06412562 assessed by blood sample results
AST (U/L), ALT (U/L)
Primary
Safety and tolerability of PF-06412562 assessed by blood sample results
white blood cell count (K/uL), platelets (K/uL)
Primary
Safety and tolerability of PF-06412562 assessed by blood sample results
hemoglobin (g/dL)
Primary
Safety and tolerability of PF-06412562 assessed by blood sample results
NA (mmol/L), K(mmol/L), HCO3(mmol/L)
Primary
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)
Primary
Safety and tolerability of PF-06412562 assessed by blood sample results
AST (U/L), ALT (U/L)
Primary
Safety and tolerability of PF-06412562 assessed by blood sample results
white blood cell count (K/uL), platelets (K/uL)
Primary
Safety and tolerability of PF-06412562 assessed by blood sample results
hematocrit (%)
Primary
Safety and tolerability of PF-06412562 assessed by blood sample results
hemoglobin (g/dL)
Primary
Safety and tolerability of PF-06412562 assessed by vital signs
blood pressure (mmHg)
Primary
Safety and tolerability of PF-06412562 assessed by blood sample results
Red blood cell count (M/uL)
Primary
Safety and tolerability of PF-06412562 assessed by vital signs
weight (lbs)
Primary
Safety and tolerability of PF-06412562 assessed by vital signs
blood pressure (mmHg)
Primary
Safety and tolerability of PF-06412562 assessed by vital signs
heart rate (bpm)
Primary
Safety and tolerability of PF-06412562 assessed by vital signs
respiratory rate (breathes/min)
Primary
Safety and tolerability of PF-06412562 assessed by vital signs
temperature (F)
Primary
Safety and tolerability of PF-06412562 assessed by vital signs
height (inches)
Primary
Safety and tolerability of PF-06412562 assessed by vital signs
blood pressure (mmHg)
Primary
Safety and tolerability of PF-06412562 assessed by vital signs
heart rate (bpm)
Primary
Safety and tolerability of PF-06412562 assessed by vital signs
respiratory rate (breathes/min)
Primary
Safety and tolerability of PF-06412562 assessed by vital signs
temperature (F)
Primary
Safety and tolerability of PF-06412562 assessed by vital signs
height (inches)
Primary
Safety and tolerability of PF-06412562 assessed by vital signs
height (inches)
Secondary
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
Other
Pilot data on potential efficacy of PF 06412562 on individual domains of sleep
8 hour overnight polysomnography (PSG): sleep study monitoring body functions, brain activity (EEG), eye movements (EOG), muscle activity (EMG), and heart rhythm (ECG) Qualitative caregiver interview: (see outcome 2 description)
Other
Pilot data on potential efficacy of PF 06412562 on individual domains of alertness
Glasgow Coma scale (GCS): records consciousness; each item rated 1-6; score range: 3-14, where 3=deep unconsciousness, 15=totally alert Stanford Sleepiness Scale (SSS): measure of alertness; rated 1-7, 1=fully alert, 7=almost asleep, min total score=1, max total score=7
Other
Pilot data on potential efficacy of PF 06412562 on individual domains of cogitation
a. Severe Impairment Battery (SIB): evaluates cognition; min total score=0, max total score=100, higher score=lower cognition COGNISTAT: cognitive screening that assesses different domains of cognition Frontal Assessment Battery (FAB): used to assess different types of dementias. Min total score=0, max total score=18, higher scores=better performance
Other
Pilot data on potential efficacy of PF 06412562 on individual domains of motor
MDS-UPDRS-motor (III) (United Parkinson's Disease Rating Scale): each question scored on scale of 0 to 4, where 0= not present, 4= severe; min total score:0, max total score:81; higher score corresponds to increased disease severity
Study 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)