Department of Neurology, Jefferson Headache Center, Thomas Jefferson University, Philadelphia, PA, USA.
Department of Neurology, Stanford University Medical Center, Stanford, CA, USA.
J Headache Pain. 2021 May 17;22(1):37. doi: 10.1186/s10194-021-01249-z.
To determine the long-term safety and tolerability profile of M207 in the acute treatment of migraine.
M207 is an investigational microneedle-based system for intracutaneous delivery of zolmitriptan for the treatment of migraine attacks. Following on the positive results of a Phase 2/3 placebo-controlled efficacy study (ZOTRIP), this study was designed to evaluate the safety of this novel product during repeated use for the treatment of migraine attacks.
In this 6-12 month open-label, multicenter observational study, participants used an eDiary to record headache symptoms and adverse events at specified intervals up to 48 h following treatment of a qualifying attack with M207 3.8 mg (intracutaneous zolmitriptan). Participants underwent clinical evaluations at specified intervals up to 12 months.
Among 335 participants who treated ≥1 migraine attack, 257 completed 6 months and 127 completed 1 year of treatment. The most common reason for withdrawal from the study was a low frequency of reported attacks post randomization. Overall, 5963 migraine attacks were treated. Most participants (96%) experienced at least 1 adverse event, the vast majority of which concerned the application site, and > 95% of which were mild. Fifteen participants (4%) withdrew due to adverse events; 4 withdrew due to 7 application site reactions, 6 of which were mild. Participants achieved pain freedom in 2477/5617 (44%) of attacks, most bothersome symptom freedom in 3315/5330 (62%) of attacks, and pain relief 2 h post-dose in 4552/5617 (81%) of attacks. Sustained pain freedom 2-24 h was seen in 1761/4698 (38%) of attacks, and 2-48 h in 1534/4429 (35%) of attacks.
The majority of participants experienced cutaneous adverse reactions such as application site erythema, swelling, and bleeding, and most reactions were scored as mild. These results are consistent with what was observed in the single migraine attack treatment ZOTRIP trial indicating that M207 is well tolerated in the setting of longer-term repeated use. Efficacy findings were also similar to those in the ZOTRIP trial.
Clinicaltrials.gov on September 13, 2017 ( NCT03282227 ).
确定 M207 在偏头痛急性治疗中的长期安全性和耐受性。
M207 是一种用于皮下递送至佐米曲普坦的新型微创系统，用于治疗偏头痛发作。在一项 2/3 期安慰剂对照疗效研究（ZOTRIP）取得积极结果后，本研究旨在评估这种新型产品在重复使用治疗偏头痛发作时的安全性。
在这项 6-12 个月的开放性、多中心观察性研究中，参与者使用电子日记在治疗合格的偏头痛发作后指定时间间隔记录头痛症状和不良事件，直至 48 小时。参与者在指定时间间隔进行临床评估，最长可达 12 个月。
在治疗≥1 次偏头痛发作的 335 名参与者中，257 名完成了 6 个月的治疗，127 名完成了 1 年的治疗。退出研究的最常见原因是随机分组后报告的发作频率较低。总体而言，治疗了 5963 次偏头痛发作。大多数参与者（96%）至少经历了 1 次不良事件，绝大多数与应用部位有关，其中超过 95%为轻度。15 名参与者（4%）因不良事件退出；4 名因 7 次应用部位反应而退出，其中 6 次为轻度。在 5617 次偏头痛发作中，有 2477 次（44%）达到了疼痛无缓解，在 5330 次偏头痛发作中，有 3315 次（62%）达到了最困扰症状无缓解，在 5617 次偏头痛发作中，有 4552 次（81%）在给药后 2 小时达到了疼痛缓解。在 4698 次偏头痛发作中，有 1761 次（38%）在 2-24 小时内持续疼痛缓解，在 4429 次偏头痛发作中，有 1534 次（35%）在 2-48 小时内持续疼痛缓解。
大多数参与者经历了皮肤不良反应，如应用部位红斑、肿胀和出血，大多数反应评为轻度。这些结果与单偏头痛发作治疗 ZOTRIP 试验中观察到的结果一致，表明 M207 在长期重复使用时具有良好的耐受性。疗效结果也与 ZOTRIP 试验相似。
Clinicaltrials.gov 于 2017 年 9 月 13 日注册（NCT03282227）。
