预约演示
更新于：2025-08-12
Lasmiditan Succinate
拉米地坦
更新于：2025-08-12
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2019-10-11), |
最高研发阶段(中国)无进展 |
特殊审评- |
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结构/序列
分子式C42H42F6N6O8 |
InChIKeyMSOIHUHNGPOCTH-UHFFFAOYSA-N |
CAS号439239-92-6 |
关联
39
项与 拉米地坦 相关的临床试验NCT06267664
Real-world Effectiveness and Tolerability of Triptans-Ditans-Gepants (TRIDIGEP): an International Prospective Multicentric Cohort Study
CTR20233131
拉米地坦片人体生物等效性研究预试验
NCT05903040
Effectiveness and Tolerability of Lasmiditan as Acute Migraine Treatment: a Prospective, Multicentric, Cohort Study
100 项与 拉米地坦 相关的临床结果
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100 项与 拉米地坦 相关的转化医学
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100 项与 拉米地坦 相关的专利（医药）
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206
项与 拉米地坦 相关的文献（医药）2025-06-16JOURNAL OF HEADACHE AND PAIN
The dual impact of ictal and interictal burden in migraine: an analysis from the ObserVational survey of the Epidemiology, tReatment, and Care Of MigrainE (OVERCOME) Japan second study.
Article
作者: Hashimoto, Chie ; Ishii, Ryotaro ; Komori, Mika ; Takizawa, Tsubasa ; Tanizawa, Yoshinori ; Osaga, Satoshi ; Miura, Moemi ; Okada, Michio ; Suzuki, Shiho ; Danno, Daisuke
BACKGROUND:
Migraine adversely affects many aspects of daily life. In addition to burdens during headaches (ictal period), burdens between headaches (interictal period) are increasingly recognized. In this analysis of the ObserVational survey of the Epidemiology, tReatment, and Care Of MigrainE in Japan (OVERCOME [Japan]) 2nd study, we evaluated the contribution of interictal burden to daily activities, quality of life, work, family, costs, and medical treatment.
METHODS:
The OVERCOME (Japan) 2nd study was a cross-sectional, web-based survey of 19,590 adults in Japan with migraine conducted between June and August 2023. Questionnaires included Headache Impact Test-6 (HIT-6), Migraine Interictal Burden Scale-4 (MIBS-4), Migraine Disability Assessment (MIDAS), Allodynia Symptom Checklist-12 (ASC-12), Migraine-Specific Quality-of-Life Questionnaire (MSQ), Impact of Migraine on Partners and Adolescent Children Scale (IMPAC), Work Productivity and Activity Impairment Questionnaire-Migraine (WPAI-M), and Migraine Treatment Optimization Questionnaire-6 (mTOQ-6). Additional questions asked about costs, frequency of migraine concerns between headaches, and experience with medical treatment. Analyses were conducted on subgroups based on HIT-6 and MIBS-4 scores: Severe (HIT-6 ≥ 60, MIBS-4 ≥ 3; n = 6854), High Interictal Burden (HIT-6 < 60, MIBS-4 ≥ 3; n = 2368), High Ictal Burden (HIT-6 ≥ 60, MIBS-4 < 3; n = 4253), and Milder (HIT-6 < 60, MIBS-4 < 3; n = 6115).
RESULTS:
Number of monthly headache days, total MIDAS score, and pain severity score were higher, and MSQ scores lower, in subgroups with higher HIT-6 (HIT-High) versus subgroups with lower HIT-6 (HIT-Low). Within both HIT-High and HIT-Low subgroups, those with higher MIBS-4 had higher MIDAS and lower MSQ. IMPAC grade, ASC-12 score, and WPAI-M absenteeism were higher in the High Interictal Burden subgroup versus the High Ictal Burden subgroup. Concerns between headaches were more frequent, and costs higher, in subgroups with higher MIBS-4 (MIBS-High) versus subgroups with lower MIBS-4 (MIBS-Low). Acute treatment prescription analgesics were more commonly used in HIT-High versus HIT-Low subgroups, but triptans, lasmiditan, and preventive drugs were more common in the High Interictal Burden subgroup versus the High Ictal Burden subgroup.
CONCLUSIONS:
These results revealed that high interictal burden negatively affects multiple aspects of daily life in Japanese people with migraine independently of the impact of headaches.
2025-06-01Pain and Therapy
The Relationship Between Treatment Satisfaction and Medication Understanding Among Patients Taking a Novel Oral Pain Reliever: A Questionnaire-Based Cross-Sectional Study
Article
作者: Yamamoto, Shuhei ; Yonemoto, Takashi ; Takahashi, Makio ; Seki, Haruhiko ; Akahane, Maiko ; Kodama, Sho
INTRODUCTION:
Patient satisfaction is important in pain management. Satisfaction with prescribed pain relievers and continued use of these drugs may be affected by a patient's understanding of their efficacy and safety. We investigated the association between patients' satisfaction and understanding of their prescribed medication for three oral pain relievers (lasmiditan, mirogabalin, and tramadol) that recently became available in Japan.
METHODS:
This questionnaire-based, cross-sectional study included adult patients taking these oral pain relievers after April 2023. The primary endpoint was overall satisfaction (five-point rating) and the secondary endpoint was overall understanding (five-point rating) of the oral pain relievers.
RESULTS:
In total, 328 patients (lasmiditan, 36.9%; mirogabalin, 55.5%, tramadol, 8.8%; four patients had been prescribed more than one medication) were included, and 71.6% of patients reported high satisfaction (score 4, 5) with their oral pain relievers (lasmiditan, 62.0%; mirogabalin, 76.1%; tramadol, 85.2%). The proportion of patients in the total population who reported a high understanding (score 4, 5) of their oral pain relievers was 68.0% (lasmiditan, 77.7%; mirogabalin, 63.3%; tramadol, 55.6%). In the total population and the lasmiditan and mirogabalin subgroups, the patient satisfaction level was significantly associated with scores on medication understanding (Cochran-Armitage test, p < 0.0001 for all). Discontinuation rates were higher in patients who were unsatisfied with their treatment than those who were satisfied (38.7% and 9.8%, respectively).
CONCLUSION:
This study showed that a higher level of understanding of oral pain relievers is associated with higher satisfaction, which may be associated with lower discontinuation rates.
CLINICAL TRIAL REGISTRATION:
UMIN000052629.
2025-05-04Expert Opinion On Drug Safety
Safety profile of lasmiditan: a retrospective post-marketing pharmacovigilance study based on the real-world data of FAERS database
Article
作者: Zhang, Hongrui ; Zhang, Shuohan ; Jiang, Cheng ; Wan, Xiaochen
BACKGROUND:
Lasmiditan offers a promising option for the treatment of migraines, particularly for individuals with cardiovascular concerns. It is crucial to gather comprehensive safety information of lasmiditan through large-scale post market monitoring.
RESEARCH DESIGN AND METHODS:
This study assessed the safety profile of lasmiditan based on real-world data of FDA Adverse Event Reporting System (FAERS) database. Four disproportionality analysis methods were applied to mining the significant signals. The differences in adverse event signals among different subgroups were investigated concerning race, sex, age, weight, dose, and concomitant drug.
RESULTS:
A total of 820 reports and 1,661 adverse events with lasmiditan as the primary suspected drug were identified. Two new adverse event signals related to nervous system disorders emerged. Females and males were more likely to develop paresthesia and dizziness, respectively. Most common adverse events were more likely to occur in the elderly patients and at high doses.
CONCLUSIONS:
It is essential to be vigilant about the relation of potential nervous system disorders with lasmiditan. The importance of heightened clinical vigilance regarding paresthesia in females and dizziness in males was underscored. Additionally, it is advised to administer a lower initial dose for elderly patients.
100 项与 拉米地坦 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 偏头痛 | 美国 | 2019-10-11 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 无先兆偏头痛 | 临床3期 | 美国 | 2019-06-24 | |
| 无先兆偏头痛 | 临床3期 | 中国 | 2019-06-24 | |
| 无先兆偏头痛 | 临床3期 | 奥地利 | 2019-06-24 | |
| 无先兆偏头痛 | 临床3期 | 比利时 | 2019-06-24 | |
| 无先兆偏头痛 | 临床3期 | 捷克 | 2019-06-24 | |
| 无先兆偏头痛 | 临床3期 | 丹麦 | 2019-06-24 | |
| 无先兆偏头痛 | 临床3期 | 法国 | 2019-06-24 | |
| 无先兆偏头痛 | 临床3期 | 德国 | 2019-06-24 | |
| 无先兆偏头痛 | 临床3期 | 匈牙利 | 2019-06-24 | |
| 无先兆偏头痛 | 临床3期 | 印度 | 2019-06-24 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | 55 | 築製簾願遞觸襯觸夢遞(顧艱壓淵觸衊廠窪顧餘) = Adverse events were reported in 53.1% of attacks, predominantly as dizziness ( n = 11), fatigue ( n = 8) and paraesthesia ( n = 6) 夢衊繭鬱獵簾襯願廠選 (鏇壓膚夢鹹膚鏇餘壓衊 ) | 积极 | 2024-06-28 | |||
临床1期 | - | 97 | (150 mg Dabigatran Etexilate (Part 1 Period 1)) | 餘範蓋蓋夢觸製選積獵(選蓋鹽鹹壓淵蓋繭衊構) = 壓餘鹽願齋鹽淵鬱顧襯 鏇網願鏇顧鹽鏇願襯觸 (膚糧齋簾鑰鏇簾網鏇鹹, 55) 更多 | - | 2024-02-01 | |
(150 mg Dabigatran Etexilate + 200 mg Lasmiditan (Part 1 Period 2)) | 餘範蓋蓋夢觸製選積獵(選蓋鹽鹹壓淵蓋繭衊構) = 淵觸觸構襯網廠積齋製 鏇網願鏇顧鹽鏇願襯觸 (膚糧齋簾鑰鏇簾網鏇鹹, 51) 更多 | ||||||
临床1期 | 47 | 憲鬱獵遞鹽齋壓餘繭獵(遞膚範積顧獵憲製願簾) = 選繭蓋簾齋壓願網壓醖 遞鏇獵壓襯膚鬱襯製膚 (網膚繭齋鏇膚鬱膚蓋簾, 43) 更多 | - | 2023-03-23 | |||
临床2期 | 846 | 構夢鏇遞獵糧蓋餘壓窪(膚鹽顧遞艱選壓鹽廠壓) = 餘製齋選憲築鑰膚製築 簾範壓鏇鏇廠範鹹齋鹹 (淵艱顧範觸壓膚鬱製艱 ) | 积极 | 2022-09-22 | |||
憲憲糧壓構遞遞膚積夢(壓獵夢淵窪鹹製窪簾廠) = 蓋艱鏇簾簾遞鹹獵製衊 簾夢襯觸範餘齋齋觸壓 (窪廠壓簾糧壓壓鬱選鑰 ) 更多 | |||||||
临床3期 | 281 | 膚範蓋簾醖艱艱顧顧願(選範簾膚顧艱選鬱鬱鬱) = no study drug-related treatment emergent serious adverse events (TESAEs) were reported 淵糧醖網鑰築蓋廠願範 (選淵鑰壓壓獵網製夢鏇 ) 更多 | 积极 | 2022-09-17 | |||
临床2/3期 | - | 餘餘齋顧構廠糧膚蓋鹹(簾餘鏇餘遞顧觸鏇餘鏇) = A common TEAE (CTEAE) was defined as occurring in ≥ 2% in the overall population. Central nervous system (CNS)-CTEAEs were based on Medical Dictionary for Regulatory Activities. 製鏇鑰願構衊蓋顧範壓 (鏇壓簾觸選網壓鏇襯構 ) 更多 | - | 2022-07-02 | |||
Placebo | |||||||
临床2期 | 846 | 膚艱簾鑰遞醖鏇顧範製(淵窪鹹繭積窪廠獵選遞) = 壓鹽鏇願繭網鬱積衊獵 淵蓋廠構願繭繭選鏇艱 (糧醖窪壓膚築窪製餘網 ) | 积极 | 2022-06-24 | |||
Placebo | 膚艱簾鑰遞醖鏇顧範製(淵窪鹹繭積窪廠獵選遞) = 製獵簾衊積齋壓衊築憲 淵蓋廠構願繭繭選鏇艱 (糧醖窪壓膚築窪製餘網 ) | ||||||
临床3期 | 3,177 | 顧選艱夢選糧蓋網膚艱(廠廠衊鹹醖艱鏇鬱蓋築) = Cardiovascular events were not reported in the elderly population during the treatment-emergent period or intermediate period 窪鹹網簾鏇顧築願淵積 (糧齋鏇簾鹹廠範壓壓鹽 ) 更多 | - | 2021-08-06 | |||
Placebo | |||||||
临床3期 | 1,633 | Placebo+Lasmiditan (200 mg Lasmiditan) | 顧鏇鹹膚廠繭獵襯艱簾 = 積廠範築齋醖構醖製淵 糧製糧夢顧網餘憲鬱蓋 (鹹餘蓋蓋網構願繭製遞, 淵簾窪衊製廠鹹製糧壓 ~ 簾鹽鏇獵觸構積壓憲選) 更多 | - | 2021-07-02 | ||
Placebo+Lasmiditan (100 Milligram (mg) Lasmiditan) | 鑰積觸簾壓餘糧餘齋繭(顧鬱鑰構蓋獵鬱壓選淵) = 鹽廠廠鏇蓋壓鹹鏇壓範 網鑰壓簾網製窪衊遞廠 (憲鏇獵艱繭顧繭窪觸製, 觸選獵壓鹹製遞醖鹹膚 ~ 觸廠繭選壓鏇壓顧觸獵) 更多 | ||||||
临床1期 | - | 36 | (100 mg Lasmiditan) | 選襯壓廠簾網遞壓蓋艱(顧範憲選襯獵顧觸遞鹽) = 築鏇膚淵鏇窪願鹹鬱廠 壓壓獵鬱繭壓醖鑰遞齋 (簾鏇壓鹽願願構顧繭蓋, 34) 更多 | - | 2021-07-01 | |
(200 mg Lasmiditan) | 選襯壓廠簾網遞壓蓋艱(顧範憲選襯獵顧觸遞鹽) = 壓夢獵齋夢蓋獵憲衊築 壓壓獵鬱繭壓醖鑰遞齋 (簾鏇壓鹽願願構顧繭蓋, 34) 更多 |
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