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Lasmiditan (LY573144) 治疗 6 至 17 岁偏头痛儿童的 12 个月研究 (PIONEER-PEDS2)

2026年5月29日 更新者：Eli Lilly and Company

Lasmiditan 用于儿童偏头痛患者的 3 期、为期 12 个月的开放标签研究 - PIONEER-PEDS2

之所以进行这项为期 12 个月的开放标签研究，是为了了解研究药物 lasmiditan 对于 6 至 17 岁儿童偏头痛的间歇性急性治疗是否安全有效。 该研究将持续约 12 个月，最多可能包括 7 次就诊。

研究概览

地位

终止

条件

干预/治疗

研究类型

介入性

注册 (实际的)

558

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 俄罗斯
      • Moscow、俄罗斯、121467
        • Limited Liability Company University Clinic of headaches
      • Novosibirsk、俄罗斯、630091
        • Sibneyromed Urban Neurological Center
  • 加拿大
      • Sarnia、加拿大、N7T 4X3
        • Bluewater Clinical Research Group Inc.
  • 印度
      • Gurgaon、印度、122003
        • Artemis Hospital
      • Mangalore、印度、575003
        • Mangala Hospital & Mangala Kidney Foundation
      • Nagpur、印度、440012
        • Getwell Hospital and Research Institute
      • New Delhi、印度、110060
        • Sir Ganga Ram Hospital
      • New Delhi、印度、110002
        • G.B. Pant Institute of Postgraduate Medical Education & Research
      • Thane、印度、401107
        • Bhakti Vedanta Hospital and Research Institute
  • 墨西哥
      • Aguascalientes、墨西哥、20116
        • Centro de Investigacion Medica Aguascalientes
      • Chihuahua City、墨西哥、31203
        • Unidad de Investigación en Salud
      • Cuernavaca、墨西哥、1203
        • AGNI Research and Assessment S.C.
      • Guadalajara、墨西哥、44690
        • PanAmerican Clinical Research - Guadalajara
      • Monterrey、墨西哥、66460
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • 德国
      • Bad Homburg、德国、61348
        • Private Practice - Dr. Irma Schöll
      • Freiburg im Breisgau、德国、79106
        • Universitaetsklinikum Freiburg
  • 意大利
      • Bari、意大利、70123
        • Ospedale San Paolo Bari
      • Milan、意大利、20133
        • IRCCS Istituto Neurologico Carlo Besta
      • Naples、意大利、80131
        • Università degli Studi della Campania Luigi Vanvitelli
      • Pavia、意大利、27100
        • Fondazione Istituto Neurologico C. Mondino
      • Roma、意大利、00165
        • Ospedale Pediatrico Bambino Gesu
  • 日本
      • Hiroshima、日本、730-8518
        • Hiroshima City Hospital
      • Kagoshima、日本、890-0052
        • Tanaka Neurosurgery&Headache Clinic
      • Kai、日本、400-0124
        • Nagaseki Headache Clinic
      • Kiryū、日本、376-0035
        • Hikita Pediatric clinic
      • Kobe、日本、658-0064
        • Konan Hospital
      • Kochi、日本、780-8011
        • Umenotsuji Clinic
      • Kyoto、日本、605-0981
        • Japanese Red Cross Kyoto Daiichi Hospital
      • Kyoto、日本、600-8811
        • Tatsuoka Neurology Clinic
      • Minato、日本、108-0075
        • Shinagawa Strings Clinic
      • Nishinomiya、日本、663-8501
        • Hyogo College of Medicine
      • Nishinomiya、日本、663-8014
        • Nishinomiya Municipal Central Hospital
      • Nishinomiya、日本、663-8204
        • Yamaguchi Clinic
      • Osaka、日本、556-0017
        • Tominaga Hospital
      • Sendai、日本、982-0014
        • Sendai Headache and Neurology Clinic
      • Shinjuku-ku、日本、160-0023
        • Tokyo Medical University Hospital
      • Tokyo、日本、151-0051
        • Tokyo Headache Clinic
  • 比利时
      • Brussels、比利时、1090
        • UZ Brussel
      • Saint-Nicolas、比利时、4460
        • Private Practice - Dr. Sava Simona
  • 法国
      • Amiens、法国、80054
        • Chu D'Amiens-Picardie - Hopital Sud
      • Clermont-Ferrand、法国、63100
        • Centre Hospitalier Universitaire Estaing
      • Créteil、法国、94010
        • Centre Hospitalier Intercommunal de Créteil
      • Mont-de-Marsan、法国、40024
        • Centre Hospitalier Général de Mont de Marsan - Hôpital Layné
  • 波多黎各
      • Caguas、波多黎各、00727
        • Dr. Samuel Sanchez PSC
      • Dorado、波多黎各、00646
        • Puerto Rico Health Institute
      • Ponce、波多黎各、00716
        • Ponce Medical School Foundation Inc.
      • Vega Baja、波多黎各、00694
        • Wellness Clinical Research Vega Baja
  • 罗马尼亚
      • Bucharest、罗马尼亚、41914
        • Prof. Dr. Alexandru Obregia Psychiatry Hospital
      • Iași、罗马尼亚、700309
        • Spitalul clinic de urgenta pentru copii Sf. Maria
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35205
        • Central Research Associates
      • Huntsville、Alabama、美国、35805
        • Rehabilitation & Neurological Services
    • Arizona
      • Phoenix、Arizona、美国、85016
        • Phoenix Children's Hospital
      • Scottsdale、Arizona、美国、85254
        • Perseverance Research Center
      • Tucson、Arizona、美国、85718
        • Center For Neurosciences
    • Arkansas
      • Little Rock、Arkansas、美国、72202
        • Arkansas Children's
    • California
      • Cerritos、California、美国、90703
        • Core Healthcare Group
      • Long Beach、California、美国、90806
        • Miller Children's & Women's Hospital Long Beach
      • Los Angeles、California、美国、90006
        • Sensa Health
      • Ontario、California、美国、91762
        • Orange County Research Institute - Ontario
    • Connecticut
      • New Haven、Connecticut、美国、06501
        • Yale University School Of Medicine
    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20010
        • Children's National Medical Center
    • Florida
      • Jacksonville、Florida、美国、32256
        • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
      • Jacksonville、Florida、美国、32207
        • Wolfson Children's Hospital
      • Miami、Florida、美国、33165
        • New Horizon Research Center
      • Miami、Florida、美国、33155
        • Biotech Pharmaceutical Group
      • Miami Lakes、Florida、美国、33015
        • Ezy Medical Research
      • New Port Richey、Florida、美国、34652
        • Suncoast Clinical Research, Inc.
      • Pensacola、Florida、美国、32503
        • Avanza Medical Research Center
      • Pompano Beach、Florida、美国、33060
        • Clinical Research Center Of Florida
      • Tampa、Florida、美国、33613
        • ForCare Clinical Research
      • Tampa、Florida、美国、33612
        • USF Health
      • West Palm Beach、Florida、美国、33407
        • Palm Beach Neurology
      • Winter Park、Florida、美国、32789
        • Pediatric Neurology P.A.
    • Georgia
      • Savannah、Georgia、美国、31406
        • Meridian Clinical Research, LLC
      • Union City、Georgia、美国、30291
        • Rophe Adult and Pediatric Medicine/SKYCRNG
    • Hawaii
      • Honolulu、Hawaii、美国、96817
        • Hawaii Pacific Neuroscience
    • Idaho
      • Ammon、Idaho、美国、83406
        • Medical Research Partners
      • Meridian、Idaho、美国、83642
        • Velocity Clinical Research, Boise
    • Illinois
      • Chicago、Illinois、美国、60657
        • Chicago Headache Center and Research Institute
      • Naperville、Illinois、美国、60563
        • Chicago Headache Center and Research Institute - Naperville
    • Indiana
      • Evansville、Indiana、美国、47715
        • Qualmedica Research, LLC
      • Fort Wayne、Indiana、美国、46804
        • Fort Wayne Neurological Center - West
      • Indianapolis、Indiana、美国、46256
        • Josephson Wallack Munshower Neurology, PC
      • Newburgh、Indiana、美国、47630
        • Deaconess Clinic - Gateway Health Center
    • Iowa
      • West Des Moines、Iowa、美国、50265
        • Integrated Clinical Trial Services, Inc.
    • Kentucky
      • Bowling Green、Kentucky、美国、42101
        • Qualmedica Research, LLC
      • Lexington、Kentucky、美国、40536
        • University of Kentucky Chandler Medical Center
      • Owensboro、Kentucky、美国、42301
        • Qualmedica Research, LLC
    • Louisiana
      • New Orleans、Louisiana、美国、70118
        • Children's Hospital New Orleans
      • New Orleans、Louisiana、美国、70119
        • Velocity Clinical Research - New Orleans
    • Maryland
      • Baltimore、Maryland、美国、21208
        • Pharmasite Research, Inc.
    • Massachusetts
      • Methuen、Massachusetts、美国、01844
        • ActivMed Practices and Research
      • Waltham、Massachusetts、美国、02154
        • MedVadis Research Corporation
    • Michigan
      • East Lansing、Michigan、美国、48824
        • Michigan State University
    • Minnesota
      • Burnsville、Minnesota、美国、55337
        • Minneapolis Clinic of Neurology - Burnsville Office
    • Mississippi
      • Ridgeland、Mississippi、美国、39157
        • SKY Integrative Medical Center/SKYCRNG
    • Missouri
      • Kansas City、Missouri、美国、64108
        • Children's Mercy Hospital
      • Springfield、Missouri、美国、65807
        • Clinvest Research LLC
    • New York
      • Rochester、New York、美国、14609
        • Rochester Clinical Research, Inc.
    • North Carolina
      • Monroe、North Carolina、美国、28112
        • Monroe Biomedical Research
      • Statesville、North Carolina、美国、28625
        • Accellacare - Piedmont
      • Winston-Salem、North Carolina、美国、27103
        • Accellacare - Winston-Salem
    • Ohio
      • Cincinnati、Ohio、美国、45229
        • Cincinnati Children's Hospital Medical Center
      • Cincinnati、Ohio、美国、45236
        • Headache Center of Hope
    • Oregon
      • Portland、Oregon、美国、97239
        • Oregon Health and Science University
    • Pennsylvania
      • Scottdale、Pennsylvania、美国、15683
        • Frontier Clinical Research, LLC
      • Smithfield、Pennsylvania、美国、15478
        • Frontier Clinical Research, LLC
    • Rhode Island
      • East Greenwich、Rhode Island、美国、02818
        • Velocity Clinical Research, Providence
    • South Carolina
      • Greenville、South Carolina、美国、29607
        • Tribe Clinical Research, LLC
    • Texas
      • Austin、Texas、美国、78726
        • ARC Clinical Research at Four Point
      • Corpus Christi、Texas、美国、78411
        • Driscoll Children's Hospital
      • Houston、Texas、美国、77054
        • Pain and Headache Centers of Texas
      • Waxahachie、Texas、美国、75165
        • ClinPoint Trials
    • Utah
      • Logan、Utah、美国、84341
        • Medical Research Partners - Logan
    • Washington
      • Bellevue、Washington、美国、98007
        • Northwest Clinical Research Center
      • Everett、Washington、美国、98201
        • Core Clinical Research
      • Seattle、Washington、美国、98105
        • Seattle Children's Hospital
      • Seattle、Washington、美国、98105
        • Seattle Women's: Health, Research, Gynecology
    • West Virginia
      • Huntington、West Virginia、美国、25701
        • Marshall Medical Center
      • Kingwood、West Virginia、美国、26537
        • Frontier Clinical Research
  • 英国
      • Glasgow、英国、G51 4TF
        • Royal Hospital for Sick Children
      • Great Yarmouth、英国、NR31 6LA
        • James Paget University Hospital
      • London、英国、WC1N 3JH
        • Great Ormond Street Hospital for Children NHS Foundation Trust
      • London、英国、W1G 9JF
        • Re:Cognition Health - London
      • Nottingham、英国、NG7 2UH
        • Queen's Medical Centre, Nottingham University Hospitals
      • Stockport、英国、SK2 7JE
        • Stepping Hill Hospital
  • 荷兰
      • Nijmegen、荷兰、6532 SZ
        • Canisius-Wilhelmina Ziekenhuis
      • Zwolle、荷兰、8025 AB
        • Isala, locatie Zwolle
  • 西班牙
      • Barcelona、西班牙、8035
        • Hospital Universitari Vall d'Hebron
      • Esplugues de Llobregat、西班牙、8950
        • Hospital Sant Joan de Déu
      • Madrid、西班牙、28041
        • Hospital Universitario 12 de Octubre
      • Sabadell、西班牙、8208
        • Hospital Universitari Parc Tauli
      • Seville、西班牙、41013
        • Hospital Universitario Virgen del Rocío
      • Valladolid、西班牙、47005
        • Hospital Clínico Universitario de Valladolid

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6年 至 17年 (孩子)

接受健康志愿者

不

描述

纳入标准：

  • 参与者必须完成研究 H8H-MC-LAHX (NCT03988088) 或研究 H8H-MC-LAHV（NCT 编号待定）
  • 参加者的体重必须至少为 15 公斤 (kg)

排除标准：

  • 参与者不得怀孕或哺乳
  • 参与者不得患有任何急性、严重或不稳定的健康状况
  • 根据研究者的意见，参与者不得主动自杀或有明显的自杀风险

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：25/50/100 mg Lasmiditan
  • Participants received lasmiditan [50 milligram (mg) for body weight less than or equal to 40 kilogram (≤ 40 kg) or 100 mg for body weight greater than (>)40 kg] administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
  • One dose reduction due to tolerability concerns (to 25 mg for body weight ≤40 kg or 50 mg for body weight >40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
药品：拉米迪坦
口服给药
其他名称：
  • LY573144
实验性的：50/100/200 mg Lasmiditan
  • Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight >40 kg) administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
  • One dose reduction due to tolerability concerns (to 50 mg for body weight ≤40 kg or 100 mg for body weight >40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
药品：拉米迪坦
口服给药
其他名称：
  • LY573144

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of Participants With at Least One Treatment Emergent Adverse Events (TEAEs)
大体时间：Baseline up to 12-month treatment period (Up to 12 Months)

An AE with an onset on or within 48 hours after a dose of study drug, or an event that worsened in intensity within 48 hours of a dose of study drug was considered a treatment-emergent adverse event (TEAE).

A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
Baseline up to 12-month treatment period (Up to 12 Months)
Number of Participants With Discontinuations Due to Adverse Events (AEs)
大体时间：Baseline up to 12-month treatment period (Up to 12 Months)
Participants who discontinued due to adverse events were reported in this outcome measure.
Baseline up to 12-month treatment period (Up to 12 Months)

次要结果测量

结果测量
措施说明
大体时间
Percentage of Treated Migraine Attacks With Pain Freedom (PF) at 2 Hours Post-Dose
大体时间：2 hours post-dose (for each treated migraine attack, up to 12-month treatment period)
Pain relief at 2 hours post-dose was defined as having a pain intensity of none or mild at that time point. The 5-Face Pain Scale is a single-item, self-report tool assessing pain intensity along a single domain. Participants select one face from five options to represent their current pain level; no score aggregation or calculation is performed- the selected face directly represents the pain intensity score. The five faces correspond to: Face 1= none, Face 2= mild, Faces 3-4= moderate (both faces represent moderate pain as defined by this scale, with Face 3 reflecting lower-moderate and Face 4 reflecting upper-moderate intensity) and Face 5= severe. The scale ranges from a minimum value of 1 (no pain) to a maximum value of 5 (severe pain); higher scores indicate worse outcome. Participants with a reduction in baseline pain from moderate (Faces 3 or 4) or severe (Face 5) to no pain (Face 1) at 2 hours post-dose were considered to have achieved pain freedom.
2 hours post-dose (for each treated migraine attack, up to 12-month treatment period)
Percentage of Treated Migraine Attacks With Pain Relief (PR) at 2 Hours Post-Dose
大体时间：2 hours post-dose (for each treated migraine attack, up to 12-month treatment period)
Pain relief at 2 hours post-dose was defined as having a pain intensity of none or mild at that time point. The 5-Face Pain Scale is a single-item, self-report tool assessing pain intensity along a single domain. Participants select one face from five options to represent their current pain level; no score aggregation or calculation is performed- the selected face directly represents the pain intensity score. The five faces correspond to: Face 1= none, Face 2= mild, Faces 3-4= moderate (both faces represent moderate pain as defined by this scale, with Face 3 reflecting lower-moderate and Face 4 reflecting upper-moderate intensity) and Face 5= severe. The scale ranges from a minimum value of 1 (no pain) to a maximum value of 5 (severe pain); higher scores indicate worse outcome. Participants with reduction from baseline moderate (Faces 3 or 4) or severe (Face 5) to mild or none (Face 1 or 2), or those reported as asleep at 2 hours post-dose were considered to have achieved pain relief.
2 hours post-dose (for each treated migraine attack, up to 12-month treatment period)
Percentage of Treated Migraine Attacks With Freedom From Most Bothersome Symptom (MBS) at 2 Hours After Dose
大体时间：2 hours post-dose (for each treated migraine attack, up to 12-month treatment period)

Participants identified one pre-specified most bothersome symptom (MBS) prior to each migraine dose from three options (nausea, photophobia, or phonophobia). The same pre-selected MBS was assessed at baseline (pre-dose) and at 2 hours post-dose using a binary scale recorded via electronic diary (e-Diary), where "Yes" = MBS present and "No" = MBS absent.

MBS freedom was defined as a change from MBS present ("Yes") at baseline to MBS absent ("No") at 2 hours post-dose. A response of "No" at 2 hours post-dose represents a favorable outcome. Only migraine attacks in which the MBS was reported as present at baseline were included in the analysis. No aggregation, transformation, or total score calculation was performed, as this is a single-item dichotomous assessment per attack.
2 hours post-dose (for each treated migraine attack, up to 12-month treatment period)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Eli Lilly and Company

调查人员

  • 研究主任：Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)、Eli Lilly and Company

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年6月30日

初级完成 (实际的)

2025年12月4日

研究完成 (实际的)

2025年12月4日

研究注册日期

首次提交

2020年5月18日

首先提交符合 QC 标准的

2020年5月18日

首次发布 (实际的)

2020年5月20日

研究记录更新

最后更新发布 (实际的)

2026年6月25日

上次提交的符合 QC 标准的更新

2026年5月29日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 16930
  • H8H-MC-LAHW (其他标识符：Eli Lilly and Company)
  • 2019-004379-38 (EudraCT编号)
  • 2023-506724-85-00 (克蒂斯)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

在批准研究计划和签署数据共享协议后，将在安全访问环境中提供匿名的个人患者级别数据。

IPD 共享时间框架

数据在美国和欧盟研究的适应症首次公布和批准后 6 个月提供，以较晚者为准。 数据将无限期地可供请求。

IPD 共享访问标准

研究计划必须得到独立审查小组的批准，研究人员必须签署数据共享协议。

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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