Safety and pharmacokinetic profile of rufinamide in pediatric patients aged less than 4 years with Lennox-Gastaut syndrome: An interim analysis from a multicenter, randomized, active-controlled, open-label study
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- 作者：Alexis Arzimanogloua ; aarzimanoglou@orange.fr" class="auth_mail" title="E-mail the corresponding author ; Jose A. Ferreirab ; c ; d ; jferreira@pensresearch.org" class="auth_mail" title="E-mail the corresponding author ; Andrew Satline ; Andrew_Satlin@eisai.com" class="auth_mail" title="E-mail the corresponding author ; Shannon Mendesf ; other_medicine@yahoo.com" class="auth_mail" title="E-mail the corresponding author ; Betsy Williamsg ; Betsy_Williams@eisai.com" class="auth_mail" title="E-mail the corresponding author ; David Critchleyh ; David_Critchley@eisai.net" class="auth_mail" title="E-mail the corresponding author ; Edgar Schucki ; Edgar_Schuck@eisai.com" class="auth_mail" title="E-mail the corresponding author ; Ziad Husseinj ; Ziad_Hussein@eisai.net" class="auth_mail" title="E-mail the corresponding author ; Dinesh Kumare ; Dinesh_Kumar@eisai.com" class="auth_mail" title="E-mail the corresponding author ; Shobha Dhaddae ; Shobha_Dhadda@eisai.com" class="auth_mail" title="E-mail the corresponding author ; Francesco Bibbianie ; Francesco_Bibbiani@eisai.com" class="auth_mail" title="E-mail the corresponding author
- 关键词：Lennox-Gastaut syndrome ; Rufinamide ; Antiepileptic drug therapy ; Randomized study ; Pharmacokinetic ; safety ; Infants
- 刊名：European Journal of Paediatric Neurology
- 出版年：2016
- 出版时间：May 2016
- 年：2016
- 卷：20
- 期：3
- 页码：393-402
- 全文大小：1043 K
文摘
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Study 303 features an active comparator arm with investigator-chosen add-on AEDs.
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Rufinamide was safe and well tolerated in pediatric subjects ≥1 to <4 y of age.
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Rufinamide PK in subjects ≥1 to <4 y comparable to prior analyses in LGS subjects ≥4 y.
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No adjustments necessary to weight-based dosing for rufinamide in patients ≥1 to <4 y.