Parkinson's Disease Isradipine Safety Study

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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 being completed now and is conducted in preparation to NIH submission of the pivotal study on the efficacy of this agent for neuroprotection in PD. This study is conducted in parallel with Dr. Surmeier's work on further development of the preclinical data. The focus of his work now is to establishing the correlation between the dose that demonstrated neuroprotective effect in animal model and the dose used for clinical practice.

Hypothesis 1: Patients with PD will be able to tolerate isradipine across the FDA recommended dose range. We expect 10% attrition due to hypotensive effect of the agent.

Hypothesis 2: Patients with PD and concomitant stable hypertension will be able to tolerate isradipine provided that the dose of the concomitant antihypertensive agent is adjusted based on the blood pressure reading.

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

Details

• Lead Sponsor: Northwestern University
• Collaborator: Northwestern Memorial Hospital
• Treatments: Isradipine; Neuroprotective Agents

Criteria

Inclusion Criteria:

1. Patients with idiopathic Parkinson's disease age 30-75

2. Hoehn and Yahr stage <2.5

3. PD duration less than 5 years

4. For the subjects treated with PD medications, the regimen has to be stable for >1 month prior to enrollment

Exclusion Criteria:

1. Atypical Parkinsonian syndrome

2. 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

3. 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.

4. Presence of other medical conditions that in the opinion of the investigator will preclude safe use of the drug.

5. Presence of cognitive dysfunction as determined by MMSE score <24

6. Failure to sign the informed consent

7. Inability to cooperate with the study procedures

8. Presence of motor fluctuations

9. History of bradycardia defined as heart rate < 55

10. 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

11. Participation in other investigational drug trials within 30 days prior to screening

12. History of brain surgery for Parkinson's Disease.