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

Completed · Phase 2 · Has a placebo group

Conditions studied: Parkinson Disease

In brief

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.

Key facts

Study ID

NCT00909545

Run by

Northwestern University

People needed

99

Starts

2009-07-01

Expected to finish

2012-02-01

Last updated by the study team

2013-04-17

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Parkinson Institute — Sunnyvale, California, United States
• Institute for Neurodegenerative Disorders — New Haven, Connecticut, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• University of South Flordia — Tampa, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Pacific Health Institute — Honolulu, Hawaii, United States
• Northwestern University — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Boston University — Boston, Massachusetts, United States
• Michigan State University — East Lansing, Michigan, United States
• Park Nicolet Clinic — Golden Valley, Minnesota, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• University of Rochester — Rochester, New York, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Tennessee — Memphis, Tennessee, United States
• Ottowa Hospital Civic Site — Ottawa, Ontario, Canada
• Toronto Western Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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