Single Blind Comparative Study of Clobazam (NH-15)

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  • 抗てんかん薬clobazam (NH-15) の第三相臨床試験
  • 小児難治てんかんを対象としたclonazepamとの単盲検比較法による検討
  • with Clonazepam in Intractable Childhood Epilepsies

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Abstract

A single blind clinical study of clobazam (CLB) was performed mainly in Lennox-Gastaut syndrome or its variant in childhood, in comparison with clonazepam (CZP). There was no difference in patient clinical background between the two groups. More than 50% seizure reduction was attained in 61.8% of patients treated with CLB, which is significantly (p=0.001) higher than the 21.9% achieved with CZP. The respective improvement rates (over 50% seizure reduction) with CLB and CZP were 58.8% and 31.3% in Lennox-Gastaut syndrome (p=0.166), and 66.7% and 7.1% in its variant with significant difference (p=0.002). More than half the patients taking CLB showed efficacy in all seizure types excepting myoclonic seizure. In global improvement rates, considering effects on clinical seizures, EEG and behavior, CLB (55.9%) was significantly (p=0.006) better than CZP (21.9%). Main adverse reactions, such as drowsiness, dizziness and vomiting, were observed in 41.7% of the CLB group; drowsiness, nervousness, aggressiveness, hyperkinesia and stridor were seen in 57.5% of the CZP group. No significant abnormalities in laboratory tests were detected in either group.

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