Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease
NCT ID: NCT00909545
Last Updated: 2013-04-17
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
99 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-07-31
Study Completion Date
2012-02-29
Brief Summary
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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.
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Detailed Description
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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 is feasible to achieve the serum concentrations in humans that were neuroprotective in preclinical models with the FDA approved dosage range. Pilot data demonstrate acceptable tolerability of isradipine CR in the PD population. Tolerability is inversely proportional to the dosage dependent. Considering that tolerability of isradipine CR is inversely proportional to the dosage exposure, it is essential to proceed with the dose selection tolerability study in preparation for the future efficacy trials.
The tolerability, defined as the ability to complete the study, of three dosages of isradipine CR relative to placebo in subjects with early Parkinson's disease will be examined first. The dosage that is tolerable and demonstrates preliminary efficacy will be evaluated further in the future pivotal efficacy studies.
The tolerability, defined as the ability to complete the study, of three dosages of isradipine CR relative to placebo in subjects with early Parkinson's disease will be examined first. The dosage that is tolerable and demonstrates preliminary efficacy will be evaluated further in the future pivotal efficacy studies.
Conditions
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Parkinson Disease
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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Isradipine CR 5mg
Isradipine CR 5mg/day
Group Type
ACTIVE_COMPARATOR
Isradipine CR 5mg
Intervention Type
DRUG
5mg dose: 1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
Isradipine CR 10mg
Isradipine CR 10mg/day
Group Type
ACTIVE_COMPARATOR
Isradipine CR 10mg
Intervention Type
DRUG
10mg dose: 2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
Isradipine CR 20mg
Isradipine CR 20mg/day
Group Type
ACTIVE_COMPARATOR
Isradipine CR 20mg
Intervention Type
DRUG
20mg dose: 4 Dynacirc CR 5mg tablets once daily
Placebo
Placebo
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
4 Placebo to Match (PTM) tablets once daily
Interventions
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Isradipine CR 5mg
5mg dose: 1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
Intervention Type
DRUG
Isradipine CR 10mg
10mg dose: 2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
Intervention Type
DRUG
Isradipine CR 20mg
20mg dose: 4 Dynacirc CR 5mg tablets once daily
Intervention Type
DRUG
Placebo
4 Placebo to Match (PTM) tablets once daily
Intervention Type
DRUG
Other Intervention Names
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Isradipine CR
Dynacirc CR
Isradipine CR
Dynacirc CR
Isradipine CR
Dynacirc CR
Eligibility Criteria
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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.
* 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
* 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
Minimum Eligible Age
30 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Michael J. Fox Foundation for Parkinson's Research
OTHER
Sponsor Role
collaborator
Northwestern University Dixon Fund
UNKNOWN
Sponsor Role
collaborator
The Parkinson Study Group
NETWORK
Sponsor Role
collaborator
Northwestern University
OTHER
Sponsor Role
lead
Responsible Party
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Tanya Simuni
Prinicpal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Tanya Simuni, MS
Role: STUDY_CHAIR
Northwestern University
Locations
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Parkinson Institute
Sunnyvale, California, United States
Site Status
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States
Site Status
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Site Status
University of Miami
Miami, Florida, United States
Site Status
University of South Flordia
Tampa, Florida, United States
Site Status
Emory University School of Medicine
Atlanta, Georgia, United States
Site Status
Pacific Health Institute
Honolulu, Hawaii, United States
Site Status
Northwestern University
Chicago, Illinois, United States
Site Status
Rush University Medical Center
Chicago, Illinois, United States
Site Status
Boston University
Boston, Massachusetts, United States
Site Status
Michigan State University
East Lansing, Michigan, United States
Site Status
Park Nicolet Clinic
Golden Valley, Minnesota, United States
Site Status
University of Minnesota
Minneapolis, Minnesota, United States
Site Status
Washington University
St Louis, Missouri, United States
Site Status
University of Rochester
Rochester, New York, United States
Site Status
University of Cincinnati
Cincinnati, Ohio, United States
Site Status
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Site Status
University of Tennessee
Memphis, Tennessee, United States
Site Status
Ottowa Hospital Civic Site
Ottawa, Ontario, Canada
Site Status
Toronto Western Hospital
Toronto, Ontario, Canada
Site Status
Countries
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United States
Canada
References
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Other Identifiers
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CTCC Protocol #124
Identifier Type: -
Identifier Source: org_study_id
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