A study to describe clinical effect of Clobazam in patients with epilepsy

Conditions

Health Condition 1: null- Epilepsy Health Condition 2: G409- Epilepsy, unspecified

Satishchandra P, Rathore C, Kumar A, Apte A, Mandal A, Menon B, Chauhan D, Agadi J, Gurumukhani J, Asokan K, Ramadoss K, Venkateshwarlu K, Lingappa L, Malokar M, Sundaracharya NV, Ghosh P, Gupta P, Ravat S, Vk S, Garg S, Jha SK, Shah SV, Alagesan S, Razdan S, Padhy U, Agarwal VK, Arora V, Gadekar A, Ahmed A, Gandhi K, Chodankar D, Chinchansurkar S, Arivazhahan A, Menon S, Telang N.

2025-10-16

10.1016/j.yebeh.2025.110751

Evaluation of one-year effectiveness of clobazam as an add-on therapy to anticonvulsant monotherapy in participants with epilepsy having uncontrolled seizure episodes: An Indian experience

Parthasarathy Satishchandra, Chaturbhuj Rathore, Anirudha Apte, Abhishek Kumar, Amlan Mandal et al. (25 authors)

Epilepsy & Behavior2022-04-024 citations

10.1016/j.yebeh.2022.108671

Interventions

None listed

Eligibility

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
To describe the clinical impact (seizure freedom for 12 months) of Clobazam (FrisiumÂ®) 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

Measure	Time frame
1. To evaluate safety of FrisiumÂ® 2. To evaluate the reasons for adding FrisiumÂ® 3. To describe the management of epilepsy (in addition to FrisiumÂ®) selected by the investigator for patients who are not adequately stabilized with their anticonvulsant monotherapy. 4. To evaluate the profile of the patient who are prescribed FrisiumÂ® 5. To evaluate compliance of these patients to FrisiumÂ® 6. To explore the reasons for discontinuation of FrisiumÂ®Timepoint: 12 months	—

Measure

Time frame

1. To evaluate safety of FrisiumÂ® 2. To evaluate the reasons for adding FrisiumÂ® 3. To describe the management of epilepsy (in addition to FrisiumÂ®) selected by the investigator for patients who are not adequately stabilized with their anticonvulsant monotherapy. 4. To evaluate the profile of the patient who are prescribed FrisiumÂ® 5. To evaluate compliance of these patients to FrisiumÂ® 6. To explore the reasons for discontinuation of FrisiumÂ®Timepoint: 12 months

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Countries

India

Contacts

Public ContactRaviteja Adapa

Sanofi India Limited

Deepa.Chodankar@sanofi.com9096867313

Outcome results