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Lasmiditan (LY573144) 治疗 6 至 17 岁偏头痛儿童的研究 (PIONEER-PEDS1)

2026年8月11日 更新者：Eli Lilly and Company

缓解偏头痛的儿科选择：Lasmiditan 用于急性偏头痛治疗的随机、双盲、安慰剂对照研究：PIONEER-PEDS1

进行这项研究的目的是了解 lasmiditan 对 6 至 17 岁偏头痛儿童是否安全有效。 该研究将持续长达 20 周，最多可能包括 4 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)

847

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
      • Saint Petersburg、俄罗斯、194100
        • Saint-Petersburg State Pediatric Medical University
  • 加拿大
      • Kelowna、加拿大、V1Y 1Z9
        • OCT Research ULC
      • Sarnia、加拿大、N7T 4X3
        • Bluewater Clinical Research Group Inc.
  • 印度
      • Ahmedabad、印度、380005
        • Panchshil hospital
      • 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、110029
        • All India Institute of Medical Sciences
      • 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、20217
        • 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
      • Mexico City、墨西哥、6720
        • Hospital Infantil de México Federico Gómez
      • 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
      • Varese、意大利、21100
        • Ospedale Filippo del Ponte Varese
  • 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
      • Ghent、比利时、9000
        • UZ Gent
      • 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
      • Lille、法国、59037
        • Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
      • Mont-de-Marsan、法国、40024
        • Centre Hospitalier Général de Mont de Marsan - Hôpital Layné
      • Toulouse、法国、31059
        • Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan
  • 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、00693
        • Wellness Clinical Research Vega Baja
  • 罗马尼亚
      • Bucharest、罗马尼亚、41914
        • Prof. Dr. Alexandru Obregia Psychiatry Hospital
      • Constanța、罗马尼亚、900591
        • Constanta County Emergency Clinical Hospital Sf.Ap.Andrei
      • 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
      • Exeter、California、美国、93221
        • Pine Street Pediatrics
      • Imperial、California、美国、92251
        • Sun Valley Research Center
      • 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
    • Colorado
      • Aurora、Colorado、美国、80045
        • Children's Hospital Colorado
      • Colorado Springs、Colorado、美国、80907
        • Colorado Springs Neurological Associates
    • 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.
    • Kansas
      • Wichita、Kansas、美国、67207
        • Alliance for Multispecialty Research, LLC
    • 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、02451
        • MedVadis Research Corporation
      • Worcester、Massachusetts、美国、01601
        • New England Regional headache Center, Inc
    • 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
    • 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 Wilson Parke
      • 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
      • Layton、Utah、美国、84041
        • Alliance for Multispecialty Research, LLC
      • 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 Clinical Research Center
    • 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
      • Barcelona、西班牙、8041
        • Hospital de La Santa Creu i Sant Pau
      • Esplugues de Llobregat、西班牙、8950
        • Hospital Sant Joan de Déu
      • Madrid、西班牙、28041
        • Hospital Universitario 12 de Octubre
      • Pozuelo de Alarcón、西班牙、28223
        • Hospital Universitario Quironsalud Madrid
      • 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：

  • 参与者必须具有国际头痛协会国际头痛疾病分类第 3 版 (ICHD-3) (ICHD-3 2018) 诊断标准 1.1 或 1.2.1 所定义的伴或不伴先兆偏头痛病史，并符合以下标准：

    • 偏头痛发作史超过 6 个月
    • 在筛查访视前的 2 个月内每月报告至少 2 次且不超过 8 次中度至重度偏头痛发作
    • 典型的未经治疗的偏头痛发作的持续时间（不包括睡眠）大于或等于 3 小时
    • 根据研究者的意见，参与者在以往的偏头痛治疗中没有经历过令人满意的反应
  • 参加者必须能够吞服药片
  • 对于服用偏头痛预防药物的参与者，治疗方案稳定且在筛选前已服用至少 3 个月
  • 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：双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：Stage 1: Placebo
Participants received placebo administered orally to treat a qualifying migraine attack.
药品：安慰剂
口服给药
实验性的：Stage 1: 50/100 mg Lasmiditan
Participants received lasmiditan (50 milligram (mg) for body weight ≤40 kg or 100 mg for body weight >40 kg) administered orally to treat a qualifying migraine attack.
药品：拉米迪坦
口服给药
其他名称：
  • LY573144
安慰剂比较：Stage 2: Placebo (Stage 1 Lasmiditan Non-responders)
Participants who did not respond to lasmiditan in stage 1 were randomized in stage 2 to receive placebo administered orally to treat a single migraine attack.
药品：安慰剂
口服给药
安慰剂比较：Stage 2: Placebo (Stage 1 Placebo Non-responders)
Participants who did not respond to placebo in stage 1 were randomized in stage 2 to receive placebo administered once orally to treat a single migraine attack.
药品：安慰剂
口服给药
实验性的：Stage 2: 25/50 mg Lasmiditan (Stage 1 Placebo Non-responders)
Participants who did not respond to placebo in stage 1 were randomized in stage 2 to receive lasmiditan (25 mg for body weight ≤40 kg or 50 mg for body weight >40 kg), administered orally to treat a single migraine attack.
药品：拉米迪坦
口服给药
其他名称：
  • LY573144
实验性的：Stage 2: 50/ 100mg Lasmiditan (Stage 1 Placebo Non-responders)
Participants who did not respond to placebo in stage 1 were randomized in stage 2 to receive lasmiditan (50 mg for body weight ≤40 kg or 100 mg for body weight >40 kg), administered once orally to treat a single migraine attack.
药品：拉米迪坦
口服给药
其他名称：
  • LY573144
实验性的：Stage 2: 100/200 mg Lasmiditan (Stage 1 Placebo Non-responders)
Participants who did not respond to placebo in stage 1 were randomized in stage 2 to receive lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight >40 kg), administered once orally to treat a single migraine attack.
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
Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-Dose
大体时间：2 hours post dose
Pain freedom at 2 hours post-dose was defined as having a pain intensity of none at that time point. Pain was measured on a 5-face pain scale, with following scores: 1= none, 2= mild, 3 and 4= moderate, 5= severe. Participants with a reduction in baseline pain as measured on a 5-Face Pain Scale from moderate (Faces 3 and 4) or severe (Face 5) to no pain (Face 1) were considered as pain freedom. 5-Face Pain Scale; minimum value: 1 (no pain); maximum value: 5 (severe pain); higher scores indicate worse outcome.
2 hours post dose

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-Dose (Age Sub-Groups)
大体时间：2 hours post-dose
Pain freedom at 2 hours post-dose was defined as having a pain intensity of none at that time point. Pain was measured on a 5-face pain scale, with following scores: 1= none, 2= mild, 3 and 4= moderate, 5= severe. Participants with a reduction in baseline pain as measured on a 5-Face Pain Scale from moderate (Faces 3 and 4) or severe (Face 5) to no pain (Face 1) were considered as pain freedom. 5-Face Pain Scale; minimum value: 1 (no pain); maximum value: 5 (severe pain); higher scores indicate worse outcome.
2 hours post-dose
Percentage of Participants With Pain Relief at 2 Hours Post-Dose
大体时间：2 hours post-dose
Pain relief at 2 hours post-dose was defined as a pain intensity of none or mild at that time point. Pain was measured on a 5-face pain scale, with following scores: 1= none, 2= mild, 3 and 4= moderate, 5= severe. Participants with a reduction in baseline pain from moderate (Faces 3 and 4) or severe (Face 5) to mild or no pain (Face 1 or 2) or patient is asleep were considered to have pain relief. 5-Face Pain Scale; minimum value: 1 (no pain); maximum value: 5 (severe pain); higher scores indicate worse outcome.
2 hours post-dose
Percentage of Participants Who Had Freedom From Most Bothersome Symptom (MBS) Associated With Migraine at 2 Hours Post-Dose
大体时间：2 hours post-dose
MBS freedom was defined as MBS reported before dosing that was absent post-dose. MBS included nausea, photophobia, or phonophobia. MBS were measured using a binary scale (Yes/No) using electronic diary (e-Diary) at 2-hours post-dose. Participants who captured as "No" (MBS absent) were considered to have freedom from MBS.
2 hours post-dose
Percentage of Participants With Freedom From Nausea at 2 Hours Post-Dose
大体时间：2 hours post-dose
Nausea status was measured as absent or present in the e-Diary. Freedom from nausea was defined as nausea absent. Participants who captured as "No" (Nausea absent) were considered to have freedom from nausea.
2 hours post-dose
Percentage of Participants With Freedom From Photophobia at 2 Hours Post-Dose
大体时间：2 hours post-dose
Photophobia (sensitivity to light) status was measured as absent or present in the e-Diary. Freedom from photophobia was defined as photophobia absent. Participants who captured as "No" (Photophobia absent) were considered to have freedom from photophobia.
2 hours post-dose
Percentage of Participants With Freedom From Phonophobia at 2 Hours Post-Dose
大体时间：2 hours post-dose
Phonophobia (sensitivity to sound) status was measured as absent or present in the e-Diary. Freedom from phonophobia was defined as phonophobia absent. Participants who captured as "No" (phonophobia absent) were considered to have freedom from phonophobia.
2 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 Through 24 Hours Post-Dose
大体时间：2 through 24 hours post-dose
Sustained pain freedom from 2 through 24 hours post-dose was defined as a pain intensity of none at all time points with 24 hours post-dose. Pain intensity was assessed using a 5-Face Pain Scale (1 = none, 2 = mild, 3 or 4 = moderate, 5 = severe). Participants with score of 1 (with no pain) through 2 to 24 hours post-dose with no use of rescue medication or no relapse within the 24 hours of the initial treatment were considered to have sustained pain freedom. 5-Face Pain Scale; minimum value: 1 (no pain); maximum value: 5 (severe pain); higher scores indicate worse outcome.
2 through 24 hours post-dose
Percentage of Participants Who Used Rescue Medication for Migraine From 2 Through 24 Hours Post-Dose
大体时间：2 through 24 hours post-dose
Rescue medication was permitted after completion of the 2-hour assessment if the migraine did not respond (participant was not pain free).
2 through 24 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 Through 48 Hours Post-Dose
大体时间：2 through 48 hours post-dose
Sustained pain freedom from 2 through 48 hours post-dose was defined as a pain intensity of none at all time points with 48 hours post-dose. Pain intensity was assessed using a 5-Face Pain Scale (1 = none, 2 = mild, 3 or 4 = moderate, 5 = severe). Participants with score of 1 (with no pain) through 2 to 48 hours post-dose with no use of rescue medication or no relapse within the 48 hours of the initial treatment were considered to have sustained pain freedom. 5-Face Pain Scale; minimum value: 1 (no pain); maximum value: 5 (severe pain); higher scores indicate worse outcome.
2 through 48 hours post-dose
Percentage of Participants Who Used Rescue Medication for Migraine From 2 Through 48 Hours Post-Dose
大体时间：2 through 48 hours post-dose
Rescue medication was permitted after completion of the 2-hour assessment if the migraine did not respond (participant was not pain free).
2 through 48 hours post-dose
Percentage of Participants With No Disability at 2 Hours Post-Dose
大体时间：2 hours post-dose
Disability was assessed by the level of interference with normal activities using an electronic diary. Participants rated how much their migraine interfered with usual activities (e.g., play, schoolwork, or other work) using a 4 point numeric rating scale, where 0 = not at all, 1 = a little, 2 = a lot, and 3 = complete interference (required bed rest). No Disability was defined as the first time point at which a score of 0 (no interference) was reported. 4-Point Numeric Rating Scale; minimum value: 0 (not at all); maximum value: 3 (complete interference/bed rest required); higher scores indicate worse outcome. Percentages for each response category were estimated using a repeated-measures logistic mixed-effects model (treatment + time + age group + treatment*time + preventive treatment), not as a simple count divided by the Overall Number of Participants Analyzed (N). As a result, individual percentages may not correspond to a whole number of participants out of N.
2 hours post-dose
Acceptability of Tablet Formulation (Ease of Swallowing) at 24 Hours Post-Dose
大体时间：24 hours post-dose
Acceptability of the lasmiditan oral formulation (single tablet) was assessed using an electronic diary at the 24 hour post dose assessment. Participants were asked to report their experience of swallowing the study medication by responding to the question: "Think about the experience of swallowing the study medicine. How easy or hard was it for you to swallow one of the pills?" Responses were recorded on a 5 point ordinal scale: Very easy, Easy, Neither easy nor hard, Hard, or Very hard. 5-Point Ordinal Scale; minimum value: 1 (Very Easy); maximum value: 5 (Very Difficult); higher scores indicate worse outcome.
24 hours post-dose

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研究主要日期

学习开始 (实际的)

2020年6月15日

初级完成 (实际的)

2025年11月12日

研究完成 (实际的)

2025年11月12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9月2日

上次提交的符合 QC 标准的更新

2026年8月11日

最后验证

2026年8月1日

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其他研究编号

  • 16927
  • 2019 (美国 NIH 拨款/合同：Chief Medical Office (CMO) Alberta Health Services)
  • 2023 (美国 NIH 拨款/合同：GRAMMY Museum Foundation)
  • H8H-MC-LAHV (其他标识符：Eli Lilly and Company)
  • 2019-004378-24 (EudraCT编号)
  • 2023-506253-38-00 (克蒂斯)

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