Evidence map›Paper›PMID 36114949›Full record

Trial reportAdvances in therapy2022

Safety Findings in Lasmiditan as a Novel Acute Treatment of Migraine in Chinese Patients: A Post Hoc Analysis of the Randomized Controlled Phase 3 CENTURION Trial.

Jiying Zhou, Guogang Luo, Yuming Xu, Xiaosu Yang, Xiaoping Pan, Zhao Dong, Shiying Zhong, Hui Liu, Fei Ji, Shengyuan Yu

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Advances in therapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03670810 (Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.1field-weighted citation impact, top 50% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03670810 phase3completednot on this map

Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks

TypeinterventionalSponsorEli Lilly and CompanyRan2019 to 2021Enrolled1,633ConditionsMigraineArmsLasmiditan, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 7 institutions in 1 country.

Jiying ZhouDepartment of Neurology, The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Guogang LuoDepartment of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Yuming XuDepartment of Neurology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Xiaosu YangDepartment of Neurology, Xiangya Hospital, Central South University, Changsha, China.
Xiaoping PanDepartment of Neurology, Guangzhou First People's Hospital, South China University of Technology, Guangzhou, China.
Zhao DongDepartment of Neurology, Chinese PLA General Hospital, 28 Fuxing Road, Beijing, 100853, China.
Shiying ZhongEli Lilly and Company, Shanghai, China.
Hui LiuEli Lilly and Company, Shanghai, China.
Fei JiEli Lilly and Company, Shanghai, China.
Shengyuan YuDepartment of Neurology, Chinese PLA General Hospital, 28 Fuxing Road, Beijing, 100853, China. yusy1963@126.com.ORCID http://orcid.org/0000-0001-8933-088X
Lilly (China) · CNChinese PLA General Hospital · CNCentral South University · CNFirst Affiliated Hospital of Xi'an Jiaotong University · CNFirst Affiliated Hospital of Zhengzhou University · CNGuangzhou First People's Hospital · CNThe Affiliated Yongchuan Hospital of Chongqing Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionLasmiditan is the first 5-HT

methodsPatients were randomized 1:1:1 to lasmiditan 200 mg lasmiditan 100 mg, or a control group. The incidence of treatment-emergent adverse events (TEAEs), their severity, and incidence by treated attacks for frequently reported TEAEs (≥ 5%) were evaluated. The duration, onset, and relationship of efficacy with very common TEAEs (≥ 10%) was analyzed.

resultsA total of 281 Chinese patients were included in this post hoc analysis. No deaths and no study drug-related treatment emergent serious adverse events (TESAEs) were reported. The incidence of at least one TEAE was higher in patients receiving lasmiditan 200 mg (73.9%) and 100 mg (66.3%) versus placebo (26.6%). TEAEs were generally mild or moderate in severity, and the incidence of frequently reported TEAEs was generally highest during the first attack. Very common TEAEs with lasmiditan included dizziness, asthenia, somnolence, muscular weakness, fatigue, and nausea. The duration of dizziness was longest during the first attack. There were no cardio-cerebrovascular ischemic events and serotonin syndrome. The presence of very common TEAEs (except nausea), and severe dizziness, did not appear to have a negative influence on the efficacy.

conclusionIn the Chinese population of the CENTURION study, most of the TEAEs were neurologic, of mild or moderate severity, and self-limiting. The distribution of frequently reported TEAEs at the first attack differed from the primary cohort, while the overall safety profile of lasmiditan in the Chinese population was generally consistent with the CENTURION primary cohort. No new safety concerns were observed in the Chinese population.

trial registrationNCT03670810.

Indexed as

Migraine DisordersSerotonin Receptor AgonistsBenzamidesDizzinessDouble-Blind MethodHumansNauseaPiperidinesPyridinesTreatment OutcomeBenzamideslasmiditanPiperidinesPyridinesSerotonin Receptor AgonistsCENTURION studyChinese populationLasmiditanMigraineSafety

Identifiers

PMID36114949
OpenAlexW4296119860

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.