Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease

Exclusion Criteria

• •Subjects with a diagnosis of an atypical Parkinsonism
• •Subjects unwilling or unable to give informed consent
• •Use of CoQ10 at a dosage \>600mg daily or use of creatine \>5 grams daily within the 60 days prior to randomization
• •Exposure to dopaminergic PD therapy within 60 days prior to enrollment or for 3 months or more at any point in the past
• •History of clinically significant orthostatic hypotension or presence of orthostatic hypotension at the screening visit defined as \> 20 mmHg change in systolic BP and \>10mm change in diastolic BP after 2 min of standing, or baseline BP \<90/60
• •History of congestive heart failure
• •History of bradycardia defined as heart rate \<55
• •Presence of 2nd or 3rd degree atrioventricular block or other significant ECG abnormalities that in the investigator's opinion would compromise participation in study
• •Clinically significant abnormalities in the Screening Visit laboratory studies or electrocardiogram.
• •Presence of other known medical or psychiatric comorbidity that in the investigator's opinion would compromise participation in the study
• •Prior exposure to isradipine or other calcium channel blockers within 6 months of baseline
• •Subjects with history of hypertension treated with a maximum of 2 other antihypertensive agents will be allowed provided that the doses of concomitant anti HTN therapy can be reduced/adjusted during the study based on the BP readings in consultation with the subject's primary care physician or cardiologist.
• •Use of grapefruit juice, Ginkgo biloba, St. John's wart and/or ginseng will be prohibited during the study (as they interfere with the metabolism of isradipine).
• •Presence of cognitive dysfunction defined by a Mini Mental Status Exam ( MMSE) score \< 26 at screening
• •Subjects with clinically significant depression as determined by a Beck Depression Inventory (BDI) score \>15 at screening
• •History of exposure to typical or atypical antipsychotics or other dopamine blocking agents within 6 months prior to enrollment
• •Subjects have to be on a stable regimen of central nervous system acting medications (benzodiazepines, antidepressants, hypnotics) for 30 days prior to enrollment
• •Lactating women or women of childbearing potential who are not surgically sterilized have to use a reliable measure of contraception and have a negative serum pregnancy test at screening
• •Participation in other investigational drug trials within 30 days prior to screening
• •History of brain surgery for PD