Parkinson's Disease Isradipine Safety Study
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Dynacirc CR (Isradipine)
Intervention description: Dynacirc CR is given by the recommended schedule for titration. Subjects start on a 5mg dose and are increased in increments of 5mg every 2 weeks provided that the subjects do not have significant adverse events or symptomatic orthostatic hypotension.
Intervention MeSH terms: Isradipine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 30 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Parkinson's disease; Isradipine; Neuroprotection

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.
    

Eligibility 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.