Status:
COMPLETED
Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Michael J. Fox Foundation for Parkinson's Research
Northwestern University Dixon Fund
Conditions:
Parkinson Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief 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.
Detailed Description
There is solid scientific rational and preclinical data supporting a clinical trial of isradipine CR as a potential disease modifying agent in early PD. Human pharmacokinetic data demonstrate that it ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00909545
Start Date
July 1 2009
End Date
February 1 2012
Last Update
April 17 2013
Active Locations (20)
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1
Parkinson Institute
Sunnyvale, California, United States, 94805
2
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States, 06510
3
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
4
University of Miami
Miami, Florida, United States, 33136