Status:
COMPLETED
Parkinson's Disease Isradipine Safety Study
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Northwestern Memorial Hospital
Conditions:
Parkinson's Disease
Eligibility:
All Genders
30-75 years
Phase:
PHASE2
Brief Summary
The objective of this study is to establish the safety and tolerability of isradipine, sustained release preparation in patients with PD. This study is a logical continuation of the project that is be...
Detailed Description
Isradipine safety profile Isradipine, FDA approved for treatment of hypertension since 1990, has a well established data on its efficacy and safety in the hypertensive population (see package insert, ...
Eligibility Criteria
Inclusion
- Patients with idiopathic Parkinson's disease age 30-75
- Hoehn and Yahr stage \<2.5
- PD duration less than 5 years
- For the subjects treated with PD medications, the regimen has to be stable for \>1 month prior to enrollment
Exclusion
- Atypical Parkinsonian syndrome
- Patients with history of stable hypertension treated with 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. The number of concomitant antihypertensive agents should not exceed two. The dose of concomitant antihypertensive agents has to be stable for \> 1 month
- 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.
- Presence of other medical conditions that in the opinion of the investigator will preclude safe use of the drug.
- Presence of cognitive dysfunction as determined by MMSE score \<24
- Failure to sign the informed consent
- Inability to cooperate with the study procedures
- Presence of motor fluctuations
- History of bradycardia defined as heart rate \< 55
- Women of childbearing potential who are not surgically sterilized have to use a reliable measure of contraception and have a negative urine pregnancy test at screening
- Participation in other investigational drug trials within 30 days prior to screening
- History of brain surgery for Parkinson's Disease.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00753636
Start Date
April 1 2008
End Date
February 1 2010
Last Update
November 15 2021
Active Locations (1)
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1
710 N. Lake Shore Dr.
Chicago, Illinois, United States, 60610