A study to describe clinical effect of Clobazam in patients with epilepsy
- Conditions
- Health Condition 1: null- EpilepsyHealth Condition 2: G409- Epilepsy, unspecified
- Registration Number
- CTRI/2017/12/010906
- Lead Sponsor
- Sanofi India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To describe the clinical impact (seizure freedom for 12 months) of Clobazam (Frisium®) as an adjunct therapy in patients who are not adequately stabilized with their anticonvulsant monotherapy.Timepoint: Time point would be 12 months for both primary and secondary outcome
- Secondary Outcome Measures
Name Time Method 1. To evaluate safety of Frisium® <br/ ><br>2. To evaluate the reasons for adding Frisium® <br/ ><br>3. To describe the management of epilepsy (in addition to Frisium®) selected by the investigator for patients who are not adequately stabilized with their anticonvulsant monotherapy. <br/ ><br>4. To evaluate the profile of the patient who are prescribed Frisium® <br/ ><br>5. To evaluate compliance of these patients to Frisium® <br/ ><br>6. To explore the reasons for discontinuation of Frisium®Timepoint: 12 months