A Phase 3 Double-Blind, Placebo Controlled, Parallel Group Study Of A Disease Modifying Agent In Subjects With Early Parkinson Disease
Posted Date: Jun 6, 2018
- Investigator: Alok Sahay
- Specialties: Parkinson's Disease, Neurology, Movement Disorders
- Type of Study: Drug
The purpose of this study is to determine if an investigational drug called isradipine is safe and helpful in slowing the rate of PD decline. Isradipine has been approved by the Food and Drug Administration (FDA) to treat high blood pressure but is considered investigational in this study, as it has not been approved for use in patients with PD. In this study we are comparing 10mg of isradipine to placebo (a pill that looks like the study drug but doesn’t have any active medication in it, like a sugar pill). Be aware that this form refers to isradipine and placebo as “study drug.” If you are eligible and choose to be in the study you will be randomized to take either: Isradipine (5mg taken by mouth twice daily) OR Placebo ‘Randomized’ means that we will use a computer program to assign you by chance to either placebo or study drug (like tossing a coin). You have an equal chance of receiving study drug or placebo. Neither you nor the researchers will know whether you are taking study drug or placebo. Isradipine can affect the function of specialized channels that are present in the types of brain cells that are affected in PD patient. These cells are usually responsible for making dopamine, which is depleted in patients with PD. Isradipine may block the damage caused by the flow of certain chemicals through these channels. Laboratory data has showed that isradipine may prevent the development of Parkinson-like symptoms in animal studies. Isradipine has been evaluated in some patients with PD. The first study with isradipine controlled release (CR) in patients with early PD and normal blood pressure found that the drug was reasonably well tolerated and safe. The controlled release formulation of isradipine is not available for use and therefore this study is using the immediate release formulation.
You Are Being Asked To Take Part In This Research Study Because You Have Been Diagnosed With Parkinson’S Disease In The Last Three Years, Were At Least 30 Years Old When You Were Diagnosed, And It Is Expected That You Will Not Need Medications To Treat The Symptoms Of Pd In The Next Three Months.
Sahay, Early Stages Of Parkinson's Disease, Newly Diagnosed, Isradipine, Parkinson's Disease
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