Hoon-Chul Kang1, Baik-Lin Eun1, Chang Wu Lee1, Han Ku Moon1, Joon-Sik Kim1, Dong Wook Kim1, Joon Soo Lee1, Kyu Young Chae1, Byung Ho Cha1, Eun Sook Suh1, Jung Chae Park1, Kyunghwa Lim1, Eun Hye Ha1, Dong Ho Song1, Heung Dong Kim1. 1. Department of Pediatrics, Epilepsy Center, Sanggye Paik Hospital, Inje University College of Medicine, SeoulDepartment of Pediatrics, Korea University College of Medicine, SeoulDepartment of Pediatrics, Wonkwang University College of Medicine, IksanDepartment of Pediatrics, Yeungnam University College of Medicine, DaeguDepartment of Pediatrics, Dong San Hospital, Keimyung University School of Medicine, DaeguDepartment of Pediatrics, Clinical Research Center, FIRST Mitochondrial Research Group, Ilsan Paik Hospital, Inje University College of Medicine, GoyangDepartment of Pediatrics, Pediatric Epilepsy Clinics, Severance Children's Hospital, Brain Research Institute, Yonsei University College of Medicine, SeoulDepartment of Pediatrics, Pochon CHA University College of Medicine, SungnamDepartment of Pediatrics, Yonsei University Wonju College of Medicine, WonjuDepartment of Pediatrics, Soonchunhyang University College of Medicine, SeoulDepartment of Pediatrics, Sowha Children's Hospital, SeoulDepartment of Child Welfare, Sookmyung Women's University, SeoulDepartment of Psychiatry, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Abstract
PURPOSE: To evaluate the cognitive and behavioral effects of topiramate (TPM) versus carbamazepine (CBZ) using efficacious doses of each drug as monotherapy for children with benign rolandic epilepsy. METHODS: A multicenter, randomized, open-label, observer-blinded, parallel-group clinical trial was conducted. TPM was introduced at a dose of 12.5 mg/day with the minimum target dose of 50 mg/day in patients <30 kg and 75 mg/day in patients >30 kg over 4 weeks. CBZ was started at a dose of 10 mg/kg/day with the minimum target dose of 20 mg/kg/day over 4 weeks. Additional individual escalation was allowed up to a maximum target dose. The primary study end point was change on a neuropsychological test battery after 28 weeks of treatment. RESULTS: Neuropsychological data were available for 88 patients (45 patients for TPM and 43 patients for CBZ). Of the cognitive variables measured, arithmetic showed significant worsening in TPM (p = 0.037). An additional test, for maze, also showed a significantly greater improvement for CBZ (p = 0.026). Of behavioral variables, no significant changes were found but the scores had a negative trend for the TPM. When 30 patients on the minimum target dose for TPM were compared to 40 patients treated with minimum target CBZ, there was no significant worsening of cognitive and behavioral effects in the TPM. CONCLUSION: The pattern of neuropsychometric changes with TPM seemed to be slightly worse overall than CBZ. However, outcome with the minimum target dose did not differ significantly in comparisons between the treatment groups.
RCT Entities:
PURPOSE: To evaluate the cognitive and behavioral effects of topiramate (TPM) versus carbamazepine (CBZ) using efficacious doses of each drug as monotherapy for children with benign rolandic epilepsy. METHODS: A multicenter, randomized, open-label, observer-blinded, parallel-group clinical trial was conducted. TPM was introduced at a dose of 12.5 mg/day with the minimum target dose of 50 mg/day in patients <30 kg and 75 mg/day in patients >30 kg over 4 weeks. CBZ was started at a dose of 10 mg/kg/day with the minimum target dose of 20 mg/kg/day over 4 weeks. Additional individual escalation was allowed up to a maximum target dose. The primary study end point was change on a neuropsychological test battery after 28 weeks of treatment. RESULTS: Neuropsychological data were available for 88 patients (45 patients for TPM and 43 patients for CBZ). Of the cognitive variables measured, arithmetic showed significant worsening in TPM (p = 0.037). An additional test, for maze, also showed a significantly greater improvement for CBZ (p = 0.026). Of behavioral variables, no significant changes were found but the scores had a negative trend for the TPM. When 30 patients on the minimum target dose for TPM were compared to 40 patients treated with minimum target CBZ, there was no significant worsening of cognitive and behavioral effects in the TPM. CONCLUSION: The pattern of neuropsychometric changes with TPM seemed to be slightly worse overall than CBZ. However, outcome with the minimum target dose did not differ significantly in comparisons between the treatment groups.
Authors: Mark A Kramer; Lauren M Ostrowski; Daniel Y Song; Emily L Thorn; Sally M Stoyell; McKenna Parnes; Dhinakaran Chinappen; Grace Xiao; Uri T Eden; Kevin J Staley; Steven M Stufflebeam; Catherine J Chu Journal: Brain Date: 2019-05-01 Impact factor: 13.501