Effectiveness and safety of clobazam as add-on therapy in children after the failure of first antiseizure medicine: a sub-analysis of the ADD-ON study
Year: 2025
Type: article
Abstract: OBJECTIVE: To study the effectiveness and safety of clobazam (CLB) as add-on therapy after the failure of initial antiseizure medicine (ASM) monotherapy in children (<18 years) with epilepsy, as part of a subanalysis of the ADD-ON study. METHODS: This was a subset analysis of the ADD-ON study (a prospective, multicentre, real-world, observational study of adding clobazam after the failure of first monotherapy) in children <18 years, conducted at 28 neurology outpatient clinics in India. Data pertaining to children with epilepsy aged <18 years in the ADD-ON study were evaluated. Seizure freedom rates at 1, 3, 6, 9, and 12 months after starting CLB were analyzed. Seizure diaries and personal interviews were used to assess seizure control and side effects. RESULTS: Of the 475 eligible participants from the ADD-ON study, 107 (22.5%) children were included. The median age was 13.0 (range, 3-17) years and 62.6% were boys. The median epilepsy duration was 2.0 years (range, 0.1-16). Majority of the children (n=43, 40.2%) had tonic-clonic seizures. The major reason for adding CLB to the existing therapy was inadequate control of seizures with current treatment (n=105, 98.1%). Of the 107 children, 92 completed one year of follow-up and were receiving CLB (retention rate: 85.9%) and at one-year, 74 (69.2%) children were seizure-free. Seizure freedom rates were similar for all seizure types. No major adverse effects related to clobazam were recorded during the study period. CONCLUSION: This subanalysis of the ADD-ON study suggests that clobazam is effective and well-tolerated as an add-on therapy for children after the failure of the first ASM monotherapy. Our preliminary results from this one-year follow-up study need to be substantiated by randomized controlled studies. TRIAL REGISTRATION NUMBER: CTRI/2017/12/010906.
Source: Epilepsy & Behavior
Authors: Parthasarathy Satishchandra, Chaturbhuj Rathore, Abhishek Kumar, Anirudha Apte, Amlan Mandal, Bindu Menon, Dushyant Chauhan, Jagadish Agadi, Jayanti Gurumukhani, K Asokan, K Ramadoss, K Venkateshwarlu, Lokesh Lingappa, Monika Malokar, Nagarjunakonda Venkata Sundaracharya, Pahari Ghosh, Praveen Gupta, Sangeeta Ravat, Sanjeev VK, Siddhartha Garg, Sudhir K Jha, Sudhir Vadilal Shah, Sundaram Alagesan, Sushil Razdan, Uma Padhy, Vinay Kumar Agarwal, Vinod Arora, Arvind Gadekar, Afnan Ahmed, Kedar Gandhi, Deepa Chodankar, Sunny Chinchansurkar, Avinash Arivazhahan, Shalini Menon, Nivedita Telang
Institutions: Zydus Lifesciences Limited (India), Paras HMRI Hospital, Patna, KPC Medical College and Hospital, AMRI Hospitals, Apollo Hospitals, Rainbow Children's Hospital, Guntur Medical College, Fortis Memorial Research Institute, King Edward Memorial Hospital and Seth G.S. Medical College, Satguru Partap Singh Hospital, Tirunelveli Medical College, Indian Institute of Management Jammu, Maharaja Krishna Chandra Gajapati Medical College and Hospital, Neurological Institute of Thailand, Sanofi (India)
Language: English
Subfield: Psychiatry and Mental health
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,060
Funder: Sanofi
OpenAlex ID: W4415258109