Abstract：
Following the CENTURION phase 3 randomized controlled trial\'s four-month double-blind phase, this 12-month open-label extension collected data for up to one year about dose optimization, patterns of use, migraine-related disability, and quality of life during lasmiditan treatment.
Migraine patients ≥18 years completing the double-blind phase and treating ≥3 migraine attacks could continue into the 12-month open-label extension. The initial oral lasmiditan dose was 100 mg; the dose could subsequently be adjusted to 50 mg or 200 mg at the investigator\'s discretion.
477 patients entered and 321 (72.1%) completed the extension; 445 (93.3%) treated ≥1 attack with lasmiditan. Of 11,327 attacks, 8654 (76.4%) were lasmiditan-treated (84.9% of these involved moderate or severe pain). By study end, 17.8%, 58.7%, and 23.4% of patients were taking lasmiditan 50, 100, and 200 mg, respectively. Mean improvements were observed in disability and quality of life. The most common treatment-emergent adverse event was dizziness (35.7% of patients, 9.5% of attacks).
During this 12-month extension, lasmiditan was associated with a high rate of study completion, most attacks were treated with lasmiditan, and patients reported improvements in migraine-related disability and quality of life. No new safety findings were observed with longer exposure.Trial registration: ClinicalTrials.gov (NCT03670810); European Union Drug Regulating Authorities Clinical Trials Database (EUDRA CT: 2018-001661-17).
Migraine patients ≥18 years completing the double-blind phase and treating ≥3 migraine attacks could continue into the 12-month open-label extension. The initial oral lasmiditan dose was 100 mg; the dose could subsequently be adjusted to 50 mg or 200 mg at the investigator\'s discretion.
477 patients entered and 321 (72.1%) completed the extension; 445 (93.3%) treated ≥1 attack with lasmiditan. Of 11,327 attacks, 8654 (76.4%) were lasmiditan-treated (84.9% of these involved moderate or severe pain). By study end, 17.8%, 58.7%, and 23.4% of patients were taking lasmiditan 50, 100, and 200 mg, respectively. Mean improvements were observed in disability and quality of life. The most common treatment-emergent adverse event was dizziness (35.7% of patients, 9.5% of attacks).
During this 12-month extension, lasmiditan was associated with a high rate of study completion, most attacks were treated with lasmiditan, and patients reported improvements in migraine-related disability and quality of life. No new safety findings were observed with longer exposure.Trial registration: ClinicalTrials.gov (NCT03670810); European Union Drug Regulating Authorities Clinical Trials Database (EUDRA CT: 2018-001661-17).
摘要：
背景：在CENTURION3期随机对照试验的4个月双盲期之后，这个为期12个月的开放标签扩展收集了长达一年的剂量优化数据，使用模式，偏头痛相关的残疾，以及Lasmiditan治疗期间的生活质量。
方法：偏头痛患者≥18岁，完成双盲阶段并治疗≥3次偏头痛发作，可以持续到12个月的开放标签延长期。初始口服雷米替坦剂量为100mg;随后可根据研究者的判断将剂量调整至50mg或200mg。
结果：477例患者进入，321例（72.1％）完成了扩展；445例（93.3％）用lasmiditan治疗≥1次发作。在11327次袭击中，8654（76.4％）接受了lasmiditan治疗（其中84.9％涉及中度或重度疼痛）。到研究结束时，17.8%,58.7%,23.4%的患者服用了50、100和200毫克的Lasmiditan，分别。观察到残疾和生活质量的平均改善。最常见的治疗引起的不良事件是头晕（35.7%的患者，9.5%的攻击)。
结论：在这12个月的延期期间，Lasmiditan的研究完成率很高，大多数攻击都是用lasmiditan治疗的,患者报告偏头痛相关残疾和生活质量改善.在暴露时间较长的情况下，没有观察到新的安全性发现。试验注册：ClinicalTrials.gov（NCT03670810）;欧盟药物监管机构临床试验数据库（EUDRACT：2018-001661-17）。
方法：偏头痛患者≥18岁，完成双盲阶段并治疗≥3次偏头痛发作，可以持续到12个月的开放标签延长期。初始口服雷米替坦剂量为100mg;随后可根据研究者的判断将剂量调整至50mg或200mg。
结果：477例患者进入，321例（72.1％）完成了扩展；445例（93.3％）用lasmiditan治疗≥1次发作。在11327次袭击中，8654（76.4％）接受了lasmiditan治疗（其中84.9％涉及中度或重度疼痛）。到研究结束时，17.8%,58.7%,23.4%的患者服用了50、100和200毫克的Lasmiditan，分别。观察到残疾和生活质量的平均改善。最常见的治疗引起的不良事件是头晕（35.7%的患者，9.5%的攻击)。
结论：在这12个月的延期期间，Lasmiditan的研究完成率很高，大多数攻击都是用lasmiditan治疗的,患者报告偏头痛相关残疾和生活质量改善.在暴露时间较长的情况下，没有观察到新的安全性发现。试验注册：ClinicalTrials.gov（NCT03670810）;欧盟药物监管机构临床试验数据库（EUDRACT：2018-001661-17）。
