Parkinson's Disease Isradipine Safety Study

Condition(s) targeted: Parkinson's Disease

Intervention: Dynacirc CR (Isradipine) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Northwestern University

Official(s) and/or principal investigator(s):
Tanya Simuni, M.D., Principal Investigator, Affiliation: Northwestern University

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.

Official title: Phase II Safety and Tolerability of Isradipine (A Potential Neuroprotective Agent) in Patients With Parkinson's Disease- Stage II

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Tolerability of Isradipine Based on the Number of Participants That Complete the Study

Secondary outcome:

Safety of the Standard Titration Schedule in PD Population as Measured by the Number of Patients That Are Able to Increase the Dose to 20 mg Daily

Number of Participants That Tolerated Each Dose of Isradipine

Number of Participants That Tolerated Each Dose Level of Isradipine Between PD Patients Treated With Antihypertensive Agent and Not on Antihypertensive Agent

Number of Participants That Completed the Study at Each Dose Level of Isradipine

Change in Motor UPDRS Scores: Baseline vs. Final Visit

Pharmacokinetic Data - Mean Serum Concentration and Dosage Exposure Across the Dose Range of Isradipine

Minimum age: 30 Years. Maximum age: 75 Years. Gender(s): Both.

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.

710 N. Lake Shore Dr., Chicago, Illinois 60610, United States

Starting date: April 2008
Last updated: April 29, 2013