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Study design
Design
Randomised controlled trial.
Allocation
Computer-generated random schedule stratified by age and centre.
Blinding
Care givers and assessors blind to treatment. Blinded medications were prepared, based on body weight, at a central pharmacy and sent to the participants. Blinding of different preparations was maintained with a double dummy and overencapsulation approach.
Study question
Setting
32 outpatient sites in the USA.
Patients
453 children aged 2.5–13 years, with absence epilepsy as defined clinically and confirmed on EEG. Children with high body mass index, evidence of haematopoietic or liver dysfunction and girls who were post-menarchal were excluded.
Intervention
Patients were randomised to receive ethosuximide, valproic acid or lamotrigine, with escalation of doses over a 16-week period, with dose escalation and extension to 20 weeks if there were still …
Footnotes
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Funding Supported by NIH grants. Study medicines were provided free of charge by pharmaceutical companies.