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Clinical Trials/CTRI/2017/12/010906
CTRI/2017/12/010906
Recruiting
未知

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

Sanofi India Limited0 sites0 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: null- EpilepsyHealth Condition 2: G409- Epilepsy, unspecified
Sponsor
Sanofi India Limited
Status
Recruiting
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Observational

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Not specified

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