Criteria Fulfill
Item
each subject must meet all of the following inclusion criteria to qualify for entrance into the study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Age
Item
subjects who are male or female and are aged 55 and older.
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Informed Consent Legal Guardians
Item
subjects and/or their legal guardians must be able and willing to give informed consent.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Pramipexole Dose Stable
Item
subjects must be on stable doses of pramipexole for greater than 4 weeks duration prior to screening.
boolean
C0074710 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Gender | Pregnancy Absent | Breast Feeding Absent | Childbearing Potential Contraceptive methods | Contraceptives, Oral | Injectable contraception Long-term | Hormone implant Long-term | Barrier Contraception Double | Female Condoms | Vaginal contraceptive diaphragm | Vaginal Foam Contraception | Contraceptive Sponge | Intrauterine Devices | Serum pregnancy test negative | Female Sterilization | Hysterectomy | Tubal Ligation | Postmenopausal state
Item
subjects who are female must be non-pregnant and non-nursing. women of child-bearing potential (wocbp) must use a reliable method of contraception (e.g., oral contraceptive or long-term injectable or implantable hormonal contraceptive, double-barrier methods, such as condom and diaphragm, condom and foam, condom and sponge or intra-uterine devices) and have a negative serum pregnancy test at screening. women are considered to not be of child-bearing potential if they have been surgically sterilized (physician-documented hysterectomy or tubal ligation) or if they are post-menopausal.
boolean
C0079399 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C0009905 (UMLS CUI [5])
C1262153 (UMLS CUI [6,1])
C0443252 (UMLS CUI [6,2])
C0848131 (UMLS CUI [7,1])
C0443252 (UMLS CUI [7,2])
C0004764 (UMLS CUI [8,1])
C0205173 (UMLS CUI [8,2])
C0221829 (UMLS CUI [9])
C0042241 (UMLS CUI [10])
C0042254 (UMLS CUI [11,1])
C0234007 (UMLS CUI [11,2])
C0183461 (UMLS CUI [12])
C0021900 (UMLS CUI [13])
C0430061 (UMLS CUI [14])
C0015787 (UMLS CUI [15])
C0020699 (UMLS CUI [16])
C0520483 (UMLS CUI [17])
C0232970 (UMLS CUI [18])
Parkinson Disease | Criteria Main Quantity | Resting Tremor | Bradykinesia | Muscle Rigidity | Craniocerebral Trauma Absent | Cerebrovascular accident Absent | Communicable Disease Absent | STRUCTURAL ANOMALY Absent | Abnormality Metabolic Absent
Item
subjects must have a clinical diagnosis of parkinson's based on the presence of at least 2 of the 3 cardinal criteria - rest tremor, bradykinesia, rigidity - and no obvious history of head trauma, stroke, infectious, structural, or metabolic abnormality consistent with an alternative diagnosis to parkinson's disease.
boolean
C0030567 (UMLS CUI [1])
C0243161 (UMLS CUI [2,1])
C1542147 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0234379 (UMLS CUI [3])
C0233565 (UMLS CUI [4])
C0026837 (UMLS CUI [5])
C0018674 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0038454 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0009450 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
C0749075 (UMLS CUI [9,1])
C0332197 (UMLS CUI [9,2])
C1704258 (UMLS CUI [10,1])
C0311400 (UMLS CUI [10,2])
C0332197 (UMLS CUI [10,3])
Symptoms Quantity | Somnolence ESS Questionnaire | Impaired cognition Mini-mental state examination | Hallucinations Neuropsychiatric Inventory Questionnaire | Peripheral edema Physical Examination | Ankle Circumference Measured | Calf Circumference Measured
Item
evidence of one or more of the following symptoms: somnolence (ess score ≥ 9), cognitive decline (mmse < 24 ± presence of hallucinations (npi-q), peripheral edema (present by objective physical exam with baseline ankle and calf circumference measured in centimeters).
boolean
C1457887 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C2830004 (UMLS CUI [2,1])
C3541276 (UMLS CUI [2,2])
C0338656 (UMLS CUI [3,1])
C0451306 (UMLS CUI [3,2])
C0018524 (UMLS CUI [4,1])
C3539727 (UMLS CUI [4,2])
C0085649 (UMLS CUI [5,1])
C0031809 (UMLS CUI [5,2])
C0003086 (UMLS CUI [6,1])
C0332520 (UMLS CUI [6,2])
C0444706 (UMLS CUI [6,3])
C1305418 (UMLS CUI [7,1])
C0332520 (UMLS CUI [7,2])
C0444706 (UMLS CUI [7,3])
Criteria Fulfill
Item
a subject who meets any of the following criteria will not qualify for the study:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Therapeutic procedure Somnolence | Amphetamine and derivatives | Stimulant | Provigil
Item
subjects must not be receiving any treatments for excess somnolence such as amphetamine derivatives, other stimulants or provigil.
boolean
C0087111 (UMLS CUI [1,1])
C2830004 (UMLS CUI [1,2])
C1445631 (UMLS CUI [2])
C0304402 (UMLS CUI [3])
C0722882 (UMLS CUI [4])
Cancer treatment | Heart Diseases | Kidney Diseases | Liver diseases | Lung diseases
Item
subjects with actively treated malignancies, clinically significant heart disease, kidney, liver, or pulmonary disorders will be excluded.
boolean
C0920425 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0024115 (UMLS CUI [5])
Depressive disorder | Absence Antidepressant therapy Dose Stable
Item
subjects with clinical depression who are not receiving stable doses of antidepressant therapy in excess of 4 weeks duration.
boolean
C0011581 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C1096649 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
Orthostatic Hypotension Associated with Syncope | Systolic Pressure | Diastolic blood pressure
Item
subjects with history of orthostatic hypotension (>30mm drop in systolic pressure and/or >20mm drop in diastolic pressure) associated with syncope.
boolean
C0020651 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0039070 (UMLS CUI [1,3])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
CYP1A2 Inhibitors | Cimetidine | Fluvoxamine | CYP1A2 Inducers | Omeprazole
Item
subjects started within the last 14 days on any drug known to substantially inhibit cyp1a2 (e.g., cimetidine, fluvoxamine) or induce cyp1a2 (e.g.omeprazole) (note: subjects already on these agents may be enrolled but must remain on the stable doses of the agents from 14 days prior to the beginning of the study).
boolean
C3850068 (UMLS CUI [1])
C0008783 (UMLS CUI [2])
C0085228 (UMLS CUI [3])
C3850050 (UMLS CUI [4])
C0028978 (UMLS CUI [5])
Other medical condition Unstable | Other medical condition compromises Patient safety
Item
subjects who have other medical conditions that are considered clinically unstable or that may compromise the safety of the patient during this study.
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])