Title of study

Translated by Lorena Stroka

A randomized, double-blind, parallel-Group Multicenter comparative flexible-Dose Study of Pregabalin Versus Levetiracetam as Adjunctive therapy to reduce seizure frequency in subjects with partial seizures.

Study Number: A0081157

Hospital or Institution

Subject Name

1. Nature and purpose of study

This form is called informative consent form. It contains analytical information for the study in which you’re called to take part, and a consent form which you’ll be asked to sign if you decide to participate. You’re called to take part in a research drug study that is held by Pfizer, because you experiencing partial seizures. Separately from this study you have discussed all available  choices with your doctor and have decided to examine the possibility of participation in a clinical test evaluation of two drug effects (of Pregabalin and of Levetiracetam) for your illness. Epilepsy results from abnormal nerve discharges that affect your nervous system. Epilepsy is also known as a problem with seizures. Also, it is localized when a person first arise two seizures at least that were not caused by some known reasons. Most of seizures can be caused by unknown reasons. Seizure is a sudden abnormal explozision electrical activity in the brain that always changes the way by which a person feels or acts in a short period of time. Partial seizures can not be seen easly, while others lead to complete inability. Partial seizures start with electrical discharges in a restricted area of brain. These seizures can be separated further into complex partial seizures and simple partial seizures that are based on loss of vigilance or consciousness. When a seizure is layed out in all tha brain then it is called “generalised”. During the trial it is possible that some or all of these seizures will occur. Pregabalin is approved as an adjunctive therapy in more than 50 countries for therapy of a peripheral nervous pain, as an adjunctive therapy for partial seizure occurrences in adult subjects, and inside of the European Union for therapy of generalized anxiety disorder. Levetiracetam is approved as an adjunctive therapy in many countries for the therapy of partial seizures occurrence in persons aged over 4 and for myoclonic seizures impatients aged over 12 with epilepsy. Aim of this study is to be seen if the effects of a drug (Pregabalin) in comparision with an other drug (Levetiracetam) will help in the control of seizures activity. The study will evaluate also the appearance of any sideffect and whether it is related with Pregabalin and Levetiracetam. The study will also evaluate whether subjects will present improvement in sleep, in general state of health, and in stress and depression. In study, you’ll take either active pregabalin and placebo nor active levetiracetam and placebo. Placebo is an inactive pill that does not contain any drug. You have 50% possibilitiesto get active pregabalin or active levetiracetam. You or your doctor will not know what drug you take. In the case of need your doctor can take directly such kind of information./AlbStroka.com/

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