A multicenter, randomized, placebo-controlled, double-blind, 26-week study to evaluate the efficacy and safety of amantadine HCL extended release tablets in Parkinson’s disease subjects with levodopa-induced dyskinesia
Brain & Nerve
Neal Hermanowicz, MD
Parkinson's Disease (PD), is a progressive, chronic, nerve damaging (neurodegenerative) disease in which there are symptoms of resting tremor, muscular rigidity (muscle stiffness), slowness of movement (bradykinesia), and postural instability (loss of balance which causes someone to feel unsteady). One of the drugs prescribed to PD patients is called levodopa. A side effect of this drug is that it can cause movements that you cannot control, such as twisting and spinning. These movements are called levodopa-induced dyskinesia.
Amantadine hydrochloride (HCl), has been shown to reduce the problems associated with levodopa-induced dyskinesia. In the past, amantadine hydrochloride has been given in the form of a tablet that the body absorbs right away and is taken 2 to 4 times a day. The investigational drug, Amantadine HCl Extended Release Tablet, has not been approved as a marketed product (i.e., available to be prescribed or sold) by any regulatory authorities including the US Food and Drug Administration (FDA) for this indication (though it has already been approved for PD). The purpose of the study is to evaluate the safety and the effects of two tablets of Amantadine HCl Extended Release, which releases the amantadine hydrochloride into the body more slowly, taken once a day on levodopa-induced dyskinesia. This study will also determine the best amount of amantadine to give to subjects with conditions like yours.
To qualify for this study, you must:
Please note this is only a partial list of eligibility.
- Have levodopa-induced dyskinesia
- Have been on a stable dose of levodopa for at least a month
- Are able to continue with levodopa
This study includes nine outpatient clinic visits and two telephone visits. The study takes about 17½ hours over a period of 26 weeks.
This study will provide researchers with information about whether Amantadine HCl Extended Release Tablets reduce the amount of levodopa-induced dyskinesia experienced by people like you with Parkinson’s disease. It should also help the researchers know more about the safety and side-effects of Amantadine HCl Extended Release Tablets.
If the results of this study are favorable and, along with additional studies, lead to approval by the regulatory authorities of Amantadine HCl Extended Release Tablets for use in humans for levodopa-induced dyskinesia, there may be benefits for patients in the future. These benefits may include better management of Parkinson’s disease and an improved quality of life.
You will be paid $35 for each clinic visit over the course of the study. There are nine clinic visits. Total compensation for participation in the entire study is $315. If you decide to withdraw from the study or are withdrawn by the research team, you will receive compensation for the visits and/or procedures that you have completed.
Amantadine HCl, Osmotica 3005: Amantadine HCl