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

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to establish a dosage of isradipine CR that is tolerable and demonstrates preliminary efficacy for utilization in future pivotal efficacy studies.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Collaborators: Michael J. Fox Foundation for Parkinson's Research; Northwestern University Dixon Fund; The Parkinson Study Group
• Treatments: Isradipine

Criteria

Inclusion Criteria:

• Subjects with early idiopathic PD. If tremor is not present, subjects must have unilateral onset and persistent asymmetry of the symptoms.

• Be over 30 years old at the time of diagnosis of PD.

• Hoehn & Yahr stage is less than or equal to 2.5.

• Currently not receiving dopaminergic therapy and not projected to require dopaminergic therapy for at least 6 months from enrollment.

• Use of MAO-B inhibitors (rasagiline, selegiline), amantadine, or anticholinergics will be allowed. The dosage has to be stable for 3 months prior to baseline visit and throughout the duration of the study.

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