The Effects on Cognitive Function and Behavioral Problems of Topiramate Compared to Carbamazepine 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 over 4 weeks. CBZ was started at a dose of 10 mg/kg/day with the minimum target dose...

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Bibliographic Details
Published in:Epilepsia (Copenhagen) 2007-09, Vol.48 (9), p.1716-1723
Main Authors: Kang, Hoon‐Chul, Eun, Baik‐Lin, Wu Lee, Chang, Ku Moon, Han, Kim, Joon‐Sik, Wook Kim, Dong, Soo Lee, Joon, Young Chae, Kyu, Ho Cha, Byung, Sook Suh, Eun, Chae Park, Jung, Lim, Kyunghwa, Hye Ha, Eun, Ho Song, Dong, Dong Kim, Heung
Format: Article
Language:English
Subjects:
Adolescent
Age Factors
Anticonvulsants - adverse effects
Anticonvulsants - therapeutic use
Anticonvulsants. Antiepileptics. Antiparkinson agents
Behavioral problems
Benign rolandic epilepsy
Biological and medical sciences
Carbamazepine
Carbamazepine - adverse effects
Carbamazepine - therapeutic use
Child
Child Behavior Disorders - chemically induced
Child Behavior Disorders - diagnosis
Child Behavior Disorders - epidemiology
Child, Preschool
Cognition Disorders - chemically induced
Cognition Disorders - diagnosis
Cognition Disorders - epidemiology
Cognitive function
Dose-Response Relationship, Drug
Drug Administration Schedule
Drug toxicity and drugs side effects treatment
Epilepsy, Rolandic - drug therapy
Epilepsy, Rolandic - psychology
Fructose - adverse effects
Fructose - analogs & derivatives
Fructose - therapeutic use
Headache. Facial pains. Syncopes. Epilepsia. Intracranial hypertension. Brain oedema. Cerebral palsy
Humans
Medical sciences
Miscellaneous (drug allergy, mutagens, teratogens...)
Nervous system (semeiology, syndromes)
Neurology
Neuropharmacology
Neuropsychological Tests - statistics & numerical data
Personality Inventory
Pharmacology. Drug treatments
Topiramate
Treatment Outcome
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Summary: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 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.
ISSN:0013-9580
1528-1167
DOI:10.1111/j.1528-1167.2007.01160.x