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A Pilot Phase II Double-blind, Placebo-controlled, Dosage Finding and Tolerability Study of Isradipine as a Disease-modifying Agent in Patients With Early Parkinson’s Disease
Clinical Intervention Awards 2008
Objective/Rationale:
Isradipine, a drug approved by the FDA for treatment of high blood pressure, has been found to be neuroprotective in preclinical models of parkinsonism. The objective of this study is to determine the highest dose of isradipine that is safe in PD patients and shows relative efficacy to be used in the future definitive clinical trial. Three doses will be compared to placebo.
Project Description:
The study will recruit 100 patients with early PD who are not yet taking any medications to treat PD symptoms. Patients will be assigned to one of four treatment groups (5 mg, 10 mg, 20 mg or placebo). Patients will be followed for 12 months. Safety of each dose of isradipine will be evaluated first based on the number of patients able to complete the study on their original dosage assignment, and the rate and severity of side effects. If all doses are tolerable, then the dosage that is most effective will be selected based on the comparison of the rate of progression of PD symptoms in each group over 12 months of the study. The tolerable dosage that is most effective will be used in future studies to determine if isradipine slows progression of PD.
Relevance to Diagnosis/Treatment of Parkinson ’s Disease:
Currently, nothing has been proved to stop or slow the progression of PD. Having a drug that significantly slows the progression of the disease would broaden the therapeutic window for treatments aimed at lessening the symptoms in early-stage PD patients, improving their quality of life. This study is the first step toward determining whether isradipine, or drugs with a similar target, will fill this critical need.
Anticipated Outcome:
This study will provide information on the dosage of isradipine that is safe and has highest relative efficacy (compared to the other dosages) to be used in the future definitive study that will test if isradipine is neuroprotective in patients with PD.
Isradipine, a drug approved by the FDA for treatment of high blood pressure, has been found to be neuroprotective in preclinical models of parkinsonism. The objective of this study is to determine the highest dose of isradipine that is safe in PD patients and shows relative efficacy to be used in the future definitive clinical trial. Three doses will be compared to placebo.
Project Description:
The study will recruit 100 patients with early PD who are not yet taking any medications to treat PD symptoms. Patients will be assigned to one of four treatment groups (5 mg, 10 mg, 20 mg or placebo). Patients will be followed for 12 months. Safety of each dose of isradipine will be evaluated first based on the number of patients able to complete the study on their original dosage assignment, and the rate and severity of side effects. If all doses are tolerable, then the dosage that is most effective will be selected based on the comparison of the rate of progression of PD symptoms in each group over 12 months of the study. The tolerable dosage that is most effective will be used in future studies to determine if isradipine slows progression of PD.
Relevance to Diagnosis/Treatment of Parkinson ’s Disease:
Currently, nothing has been proved to stop or slow the progression of PD. Having a drug that significantly slows the progression of the disease would broaden the therapeutic window for treatments aimed at lessening the symptoms in early-stage PD patients, improving their quality of life. This study is the first step toward determining whether isradipine, or drugs with a similar target, will fill this critical need.
Anticipated Outcome:
This study will provide information on the dosage of isradipine that is safe and has highest relative efficacy (compared to the other dosages) to be used in the future definitive study that will test if isradipine is neuroprotective in patients with PD.
Researchers
Tanya Simuni, MD
Northwestern University
