An observational study to describe the clinical impact (seizure freedom for 12 months) of clobazm (FrisiumÂ®) as an adjunct therapy in patients who are not adequately stabilized with their anticonvulsant monotherapy - ADD O

Sanofi India Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Patient more than equal to 3 years of age
•2. Investigator decides to prescribing Frisium as an adjunctive therapy in patients with epilepsy who are not adequately stabilized
•3. Signed Informed Consent obtained from the patients or legally acceptable representative prior to any study related procedure
•Note-Frisium would be prescribed by the Investigator based on his/her clinical judgement.This study will not influence the Investigators decision to either prescribe or not to prescribe Frisium.If the patient is prescribed Frisium and if he/she satisfies all the inclusion and exclusion criteria, he/she may be recruited in this study.

•1. Patient with a known hypersensitivity to clobazam or any of the excipients of Frisium 2. Patient with any history of drug or alcohol dependence 3. Patient with known case of myasthenia gravis, severe respiratory insufficiency, sleep apnoea syndrome or severe impairment of liver/ renal function 4. Patient with recognized epilepsy syndrome 5. Patient and/or caretaker will not be able to complete the patients diary
•6. Patient participating in any clinical trial or was part of a clinical trial in the last 3 months 7. Patient who is pregnant or breastfeeding

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