Geraud G E
Service de Neurologie, Hôpital Rangeuil, Toulouse, France.
Eur Neurol. 1996;36 Suppl 2:24-7. doi: 10.1159/000119100.
311C90 is an orally active 5-HT1D agonist with both central and peripheral actions that is currently being developed as an acute antimigraine treatment. Several studies have demonstrated the safety and efficacy of 311C90 in the treatment of a single migraine headache. The objectives of this open study are to assess the safety and efficacy of 311C90 when used for a period of up to one year. Patients can treat as many migraine headaches as desired with an oral treatment regimen of 311C90. An initial 5 mg dose for treatment of the migraine headache may be followed with a second 5 mg dose to treat recurrence should it develop. Safety assessments include electrocardiograms, the frequency, intensity and duration of adverse experiences, and routine haematology, urinalysis and clinical chemistry measures. Data presented here are an interim view of the database as of August 1995 and should be considered as preliminary observations. No clinically significant serious adverse experiences have been reported. The adverse experience and efficacy profile appears to be consistent with previous 311C90 studies and this dosing regimen of 311C90 was well tolerated during multiple exposures. Notably, response rates are as good after both initial and repeated exposure (up to 5 migraines).
311C90是一种具有中枢和外周作用的口服活性5-羟色胺1D（5-HT1D）激动剂，目前正作为一种急性偏头痛治疗药物进行研发。多项研究已证明311C90在治疗单次偏头痛方面的安全性和有效性。这项开放性研究的目的是评估311C90使用长达一年时间的安全性和有效性。患者可以根据需要使用311C90的口服治疗方案治疗尽可能多的偏头痛。偏头痛初始治疗剂量为5毫克，若复发可再服用5毫克进行治疗。安全性评估包括心电图、不良事件的发生频率、强度和持续时间，以及常规血液学、尿液分析和临床化学指标。此处呈现的数据是截至1995年8月该数据库的中期情况，应视为初步观察结果。尚未报告具有临床意义的严重不良事件。不良事件和疗效情况似乎与先前的311C90研究一致，且311C90的这种给药方案在多次给药期间耐受性良好。值得注意的是，初次给药和重复给药（多达5次偏头痛发作）后的有效率都很高。
