Subject: A retrospective cross-sectional, observational survey study to analyse role of levetiracetam as monotherapy in partial onset seizures with newly diagnosed epilepsy.

Epilepsy is characterized by recurrent seizures caused by abnormal neuronal discharges in the brain. ^{1, 2, 3}. Epilepsy is the third leading contributor to the global burden of disease for neurological disorders and affects 65 million people worldwide.⁴, ⁵ According meta-analysis of international studies, the prevalence of epilepsy is 6.4 cases per 1,000 persons and the annual incidence is 67.8 cases per 100,000 person-years.⁶

It is estimated that there are more than 10 million persons with epilepsy (PWE) in India⁷.Its prevalence is about 1% in our population. The prevalence is higher in the rural (1.9%) compared to urban population (0.6%).^{8, 9}

Seizures can be broadly categorized into the following two types.^{1, 2, 3} Partial onset seizures & generalized onset seizures

Partial onset seizures, originate in, or are restricted to, a localized area of the brain, with the location of the abnormal neuronal discharge determining the phenomena associate with the seizure. Further classified as simple partial, complex partial or partial with secondary generalization.¹⁰

Generalized onset seizures. Characterized by more diffuse neuronal discharges, affect both brain hemispheres at the onset of the seizure, and are further classified by the presence or absence of different phenomena (e.g. tonic, clonic, atonic, myoclonic and/or absence seizure)¹⁰

Epilepsy can persist for years and often for the patient's lifetime. ASDs (Anti-seizure drug) are the primary therapy for epilepsy and are symptomatic treatments that control seizures.¹¹ The choice of ASDs varies with different seizure types and epileptic syndromes.¹² About 30 ASDs are currently used, of which most were approved over the last 30 years.¹²

Levetiracetam monotherapy for newly diagnosed epilepsy patients study suggests that Levetiracetam (LEV) monotherapy can be effective in treating newly diagnosed epilepsy patients. 46% of patients became seizure free after starting LEV and 38% had more than a 50% reduction of their seizures. This finding is consistent with earlier studies using old and new generation AEDs ^{13, 14}.

Levetiracetam has a novel structure and unique mechanisms of action & appear to involve neuronal binding to synaptic vesicle protein 2A, inhibiting calcium release from intraneuronal stores, opposing the activity of negative modulators of GABA- and glycin-gated currents and inhibiting excessive synchronized activity between neurons. In addition, levetiracetam inhibits N-type calcium channels.¹⁰

Levetiracetam (levipil) tablets are marketed by Sun Pharmaceutical Industries Ltd. Although every product is marketed only after regulatory approval, it is important to know how it performs in day-to- day practice of individual medical practitioners. For this purpose, we have planned to conduct a survey to assess the role of Levipil tablet in patients of partial onset seizures with or without secondary generalization in patients with 16 years of age with newly diagnosed epilepsy.

We invite you to participate in this data collection activity. All you need to do is to report on a standard form your experience with levetiracetam (Levipil) in the normal course of your practice. If you agree to participate, you will need to fill data collection forms (which we call DCF).