Back to resultsPF 06412562 in Subjects With Advanced Stage Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-06412562
Standard of Care Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's Disease, Parkinson Disease, End-Stage, Progressed, Advanced Parkinson's Disease, End-Stage Parkinson's Disease, Clinical intervention, Double-blind, randomized
Eligibility 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)
Sites / Locations
- Penn State Milton S. Hershey Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PF-06412562
Standard of Care carbidopa/levodopa
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Safety and tolerability of PF-06412562 assessed by blood sample results
NA (mmol/L), K(mmol/L), HCO3(mmol/L)
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)
Safety and tolerability of PF-06412562 assessed by blood sample results
AST (U/L), ALT (U/L)
Safety and tolerability of PF-06412562 assessed by blood sample results
white blood cell count (K/uL), platelets (K/uL)
Safety and tolerability of PF-06412562 assessed by blood sample results
Hematocrit (%)
Safety and tolerability of PF-06412562 assessed by blood sample results
hemoglobin (g/dL)
Safety and tolerability of PF-06412562 assessed by blood sample results
NA (mmol/L), K(mmol/L), HCO3(mmol/L)
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)
Safety and tolerability of PF-06412562 assessed by blood sample results
AST (U/L), ALT (U/L)
Safety and tolerability of PF-06412562 assessed by blood sample results
white blood cell count (K/uL), platelets (K/uL)
Safety and tolerability of PF-06412562 assessed by blood sample results
hematocrit (%)
Safety and tolerability of PF-06412562 assessed by blood sample results
hemoglobin (g/dL)
Safety and tolerability of PF-06412562 assessed by blood sample results
Red blood cell count (M/uL)
Safety and tolerability of PF-06412562 assessed by vital signs
height (inches)
Safety and tolerability of PF-06412562 assessed by vital signs
weight (lbs)
Safety and tolerability of PF-06412562 assessed by vital signs
blood pressure (mmHg)
Safety and tolerability of PF-06412562 assessed by vital signs
heart rate (bpm)
Safety and tolerability of PF-06412562 assessed by vital signs
respiratory rate (breathes/min)
Safety and tolerability of PF-06412562 assessed by vital signs
temperature (F)
Safety and tolerability of PF-06412562 assessed by vital signs
height (inches)
Safety and tolerability of PF-06412562 assessed by vital signs
blood pressure (mmHg)
Safety and tolerability of PF-06412562 assessed by vital signs
heart rate (bpm)
Safety and tolerability of PF-06412562 assessed by vital signs
respiratory rate (breathes/min)
Safety and tolerability of PF-06412562 assessed by vital signs
temperature (F)
Safety and tolerability of PF-06412562 assessed by vital signs
height (inches)
Safety and tolerability of PF-06412562 assessed by vital signs
weight (lbs)
Safety and tolerability of PF-06412562 assessed by vital signs
blood pressure (mmHg)
Safety and tolerability of PF-06412562 assessed by vital signs
heart rate (bpm)
Safety and tolerability of PF-06412562 assessed by vital signs
respiratory rate (breathes/min)
Safety and tolerability of PF-06412562 assessed by vital signs
temperature (F)
Safety and tolerability of PF-06412562 assessed by vital signs
height (inches)
Safety and tolerability of PF-06412562 assessed by vital signs
weight (lbs)
Safety and tolerability of PF-06412562 assessed by vital signs
blood pressure (mmHg)
Safety and tolerability of PF-06412562 assessed by vital signs
heart rate (bpm)
Safety and tolerability of PF-06412562 assessed by vital signs
respiratory rate (breathes/min)
Safety and tolerability of PF-06412562 assessed by vital signs
temperature (F)
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
Blood pressure (mmHg), cold pressor test measuring blood pressure (mmHg)
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
heart rate (beats/min), sinus arrhythmia (beats/min)
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
Blood pressure (mmHg), cold pressor test measuring blood pressure (mmHg)
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
heart rate (beats/min), sinus arrhythmia (beats/min)
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
Blood pressure (mmHg), cold pressor test measuring blood pressure (mmHg)
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
heart rate (beats/min), sinus arrhythmia (beats/min)
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
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
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.
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03665454
First Posted
August 1, 2018
Last Updated
July 30, 2019
Sponsor
Milton S. Hershey Medical Center
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT03665454
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 24, 2018 (Actual)
Primary Completion Date
March 21, 2019 (Actual)
Study Completion Date
April 21, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
Pfizer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's Disease, Parkinson Disease, End-Stage, Progressed, Advanced Parkinson's Disease, End-Stage Parkinson's Disease, Clinical intervention, Double-blind, randomized
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PF-06412562
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care carbidopa/levodopa
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
PF-06412562
Intervention Description
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
Intervention Name(s)
Standard of Care Placebo
Other Intervention Name(s)
Sinemet
Intervention Description
25/100 mg tablet(s) of carbidopa/levodopa will be encapsulated and administered according to the subject's home regimen.
Primary Outcome Measure Information:
Title
Safety and tolerability of PF-06412562 assessed by blood sample results
Description
NA (mmol/L), K(mmol/L), HCO3(mmol/L)
Time Frame
Day 1
Title
Safety and tolerability of PF-06412562 assessed by blood sample results
Description
Ca (mg/dL), Mg (mg/dL), BUN( mg/dL), Creatinine (mg/dL), Bilirubin (mg/dL)
Time Frame
Day 1
Title
Safety and tolerability of PF-06412562 assessed by blood sample results
Description
AST (U/L), ALT (U/L)
Time Frame
Day 1
Title
Safety and tolerability of PF-06412562 assessed by blood sample results
Description
white blood cell count (K/uL), platelets (K/uL)
Time Frame
Day 1
Title
Safety and tolerability of PF-06412562 assessed by blood sample results
Description
Hematocrit (%)
Time Frame
Day 1
Title
Safety and tolerability of PF-06412562 assessed by blood sample results
Description
hemoglobin (g/dL)
Time Frame
Day 1
Title
Safety and tolerability of PF-06412562 assessed by blood sample results
Description
NA (mmol/L), K(mmol/L), HCO3(mmol/L)
Time Frame
Day 4
Title
Safety and tolerability of PF-06412562 assessed by blood sample results
Description
Ca (mg/dL), Mg (mg/dL), BUN (mg/dL), creatinine (mg/dL), bilirubin (mg/dL)
Time Frame
Day 4
Title
Safety and tolerability of PF-06412562 assessed by blood sample results
Description
AST (U/L), ALT (U/L)
Time Frame
Day 4
Title
Safety and tolerability of PF-06412562 assessed by blood sample results
Description
white blood cell count (K/uL), platelets (K/uL)
Time Frame
Day 4
Title
Safety and tolerability of PF-06412562 assessed by blood sample results
Description
hematocrit (%)
Time Frame
Day 4
Title
Safety and tolerability of PF-06412562 assessed by blood sample results
Description
hemoglobin (g/dL)
Time Frame
Day 4
Title
Safety and tolerability of PF-06412562 assessed by blood sample results
Description
Red blood cell count (M/uL)
Time Frame
Day 4
Title
Safety and tolerability of PF-06412562 assessed by vital signs
Description
height (inches)
Time Frame
Time Frame: Vital signs: X2 on Day 1
Title
Safety and tolerability of PF-06412562 assessed by vital signs
Description
weight (lbs)
Time Frame
X2 on Day 1
Title
Safety and tolerability of PF-06412562 assessed by vital signs
Description
blood pressure (mmHg)
Time Frame
X2 on Day 1
Title
Safety and tolerability of PF-06412562 assessed by vital signs
Description
heart rate (bpm)
Time Frame
X2 on Day 1
Title
Safety and tolerability of PF-06412562 assessed by vital signs
Description
respiratory rate (breathes/min)
Time Frame
X2 on Day 1
Title
Safety and tolerability of PF-06412562 assessed by vital signs
Description
temperature (F)
Time Frame
X2 on Day 1
Title
Safety and tolerability of PF-06412562 assessed by vital signs
Description
height (inches)
Time Frame
X3 on Days 2
Title
Safety and tolerability of PF-06412562 assessed by vital signs
Description
blood pressure (mmHg)
Time Frame
X3 on Days 2
Title
Safety and tolerability of PF-06412562 assessed by vital signs
Description
heart rate (bpm)
Time Frame
X3 on Days 2
Title
Safety and tolerability of PF-06412562 assessed by vital signs
Description
respiratory rate (breathes/min)
Time Frame
X3 on Days 2
Title
Safety and tolerability of PF-06412562 assessed by vital signs
Description
temperature (F)
Time Frame
X3 on Days 2
Title
Safety and tolerability of PF-06412562 assessed by vital signs
Description
height (inches)
Time Frame
X3 on Days 3
Title
Safety and tolerability of PF-06412562 assessed by vital signs
Description
weight (lbs)
Time Frame
X3 on Days 3
Title
Safety and tolerability of PF-06412562 assessed by vital signs
Description
blood pressure (mmHg)
Time Frame
X3 on Days 3
Title
Safety and tolerability of PF-06412562 assessed by vital signs
Description
heart rate (bpm)
Time Frame
X3 on Days 3
Title
Safety and tolerability of PF-06412562 assessed by vital signs
Description
respiratory rate (breathes/min)
Time Frame
X3 on Days 3
Title
Safety and tolerability of PF-06412562 assessed by vital signs
Description
temperature (F)
Time Frame
X3 on Days 3
Title
Safety and tolerability of PF-06412562 assessed by vital signs
Description
height (inches)
Time Frame
X2 on Day 4
Title
Safety and tolerability of PF-06412562 assessed by vital signs
Description
weight (lbs)
Time Frame
X2 on Day 4
Title
Safety and tolerability of PF-06412562 assessed by vital signs
Description
blood pressure (mmHg)
Time Frame
X2 on Day 4
Title
Safety and tolerability of PF-06412562 assessed by vital signs
Description
heart rate (bpm)
Time Frame
X2 on Day 4
Title
Safety and tolerability of PF-06412562 assessed by vital signs
Description
respiratory rate (breathes/min)
Time Frame
X2 on Day 4
Title
Safety and tolerability of PF-06412562 assessed by vital signs
Description
temperature (F)
Time Frame
X2 on Day 4
Title
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
Description
Blood pressure (mmHg), cold pressor test measuring blood pressure (mmHg)
Time Frame
X1 on Day 1 over 15 min
Title
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
Description
heart rate (beats/min), sinus arrhythmia (beats/min)
Time Frame
X1 on Day 1 over 15 min
Title
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
Description
Blood pressure (mmHg), cold pressor test measuring blood pressure (mmHg)
Time Frame
X3 on Days 2 over 15 min each time
Title
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
Description
heart rate (beats/min), sinus arrhythmia (beats/min)
Time Frame
X3 on Days 2 over 15 min each time
Title
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
Description
Blood pressure (mmHg), cold pressor test measuring blood pressure (mmHg)
Time Frame
X3 on Days 3 over 15 min each time
Title
Safety and tolerability of PF-06412562 assessed by cardiology testing/cardiac autonomic function
Description
heart rate (beats/min), sinus arrhythmia (beats/min)
Time Frame
X3 on Days 3 over 15 min each time
Title
Safety and tolerability of PF-06412562 assessed by UPDRS-IV
Description
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
Title
Safety and tolerability of PF-06412562 assessed by UPDRS-IV
Description
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
Title
Safety and tolerability of PF-06412562 assessed by Columbia Suicide Rating
Description
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
Title
Safety and tolerability of PF-06412562 assessed by Columbia Suicide Rating
Description
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
Secondary Outcome Measure Information:
Title
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
Description
• 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
Other Pre-specified Outcome Measures:
Title
Pilot data on potential efficacy of PF 06412562 on individual domains of alertness
Description
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
Time Frame
Once before and X2 after drug administration on Days 2 & 3
Title
Pilot data on potential efficacy of PF 06412562 on individual domains of cogitation
Description
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
Time Frame
Once before and X2 after drug administration on Days 2 & 3
Title
Pilot data on potential efficacy of PF 06412562 on individual domains of motor
Description
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
Time Frame
Once before and X2 after drug administration on Days 2 & 3
Title
Pilot data on potential efficacy of PF 06412562 on individual domains of sleep
Description
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)
Time Frame
PSG sleep study: Days 1-3 at bedtime
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuemei Huang, MD, PhD
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34032202
Citation
Fernandez-Mendoza J, Puzino K, Amatrudo G, Bourchtein E, Calhoun SL, Plante DT, Kaplan K. The Hypersomnia Severity Index: reliability, construct, and criterion validity in a clinical sample of patients with sleep disorders. J Clin Sleep Med. 2021 Nov 1;17(11):2249-2256. doi: 10.5664/jcsm.9426.
Results Reference
derived
PubMed Identifier
32986682
Citation
Huang X, Lewis MM, Van Scoy LJ, De Jesus S, Eslinger PJ, Arnold AC, Miller AJ, Fernandez-Mendoza J, Snyder B, Harrington W, Kong L, Wang X, Sun D, Delnomdedieu M, Duvvuri S, Mahoney SE, Gray DL, Mailman RB. The D1/D5 Dopamine Partial Agonist PF-06412562 in Advanced-Stage Parkinson's Disease: A Feasibility Study. J Parkinsons Dis. 2020;10(4):1515-1527. doi: 10.3233/JPD-202188.
Results Reference
derived
Learn more about this trial
PF 06412562 in Subjects With Advanced Stage Parkinson's Disease
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