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A Study of Lasmiditan (LY573144) Over Four Migraine Attacks

Primary Purpose

Migraine

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lasmiditan
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring acute treatment, migraine pain, multiple attacks, headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1
  • History of disabling migraine for at least 1 year
  • Migraine onset before the age of 50 years
  • History of 3 to 8 migraine attacks per month (<15 headache days per month) during the past 3 months
  • MIDAS score ≥11
  • Able and willing to complete an eDiary to record the details of each migraine attack treated with study drug
  • Women of child-bearing potential must be using or willing to use a highly effective form of contraception
  • Agree not to post any personal medical data or information related to the study on any website or social media site until the entire trial has completed

Exclusion Criteria:

  • Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets
  • History or evidence of hemorrhagic stroke, epilepsy, or any other condition placing the participant at increased risk of seizures
  • History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo, Meniere's disease, vestibular migraine, and other vestibular disorders
  • History of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy)
  • History of orthostatic hypotension with syncope
  • Significant renal or hepatic impairment in the opinion of the investigator or if they meet hepatic monitoring criteria
  • Participants who, in the investigator's judgment, are actively suicidal and therefore deemed to be at significant risk for suicide
  • History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (eg, hemicranias continua, medication overuse headache where headache frequency is ≥15 headache days per month)
  • Use of more than 3 doses per month of either opioids or barbiturates
  • Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within 3 months prior to screening
  • Pregnant or breast-feeding women
  • History of drug or alcohol abuse/dependence within 1 year prior to screening
  • Any medical condition or clinical laboratory test which in the judgment of the investigator makes the participant unsuitable for the study
  • Currently enrolled in any other clinical study involving an investigational product
  • Relatives of, or staff directly reporting to, the Investigator
  • Participants who are employees of the sponsor

Sites / Locations

  • Rehabilitation & Neurological Services LLC
  • Barrow Neurological Institute
  • UCSD Altman Clinical & Translational Research Institute (ACTRI)
  • Colorado Neurological Institute
  • Georgetown University Hospital
  • George Washington University Medical Center
  • Diamond Headache Clinic
  • Ochsner Medical Center - North Shore
  • StudyMetrix Research, LLC
  • Nevada Headache Institute
  • Dent Neurological Institute
  • Montefiore Headache Center
  • Island Neuro Associates,PC
  • Northwest Clinical Research Center
  • KH der Barmherzigen Schwestern Linz BetriebsGesmbH
  • Universitätsklinik Innsbruck
  • Christian-Doppler-Klinik
  • AKH
  • Jessa Ziekenhuis
  • Algemeen Ziekenhuis St Jan Brugge
  • Universitair Ziekenhuis Brussel
  • Universitair Ziekenhuis Gent
  • CHC MontLégia
  • Valdor - ISOSL CCV - Clinique des céphalées du Valdor - Neurology
  • Beijing Tiantan Hospital Affiliated to Capital Medical Univ
  • Xuanwu Hospital-Capital Medical University
  • The First Affiliated Hospital Chongqing Medical University
  • Guangzhou First People's Hospital
  • The University of Hong Kong-Shenzhen Hospital
  • Hebei General Hospital
  • First hospital affiliated to Zhengzhou University
  • Wuhan Union (Xiehe) Hospital
  • Xiangya Hospital, Central South University
  • The First Affliated Hospital of Suzhou University
  • Affiliated Hospital of Jiangsu University
  • First Affiliated Hospital of Gannan Medical University
  • Pingxiang People's Hospital
  • No.2 Hospital Affiliated to Jilin University
  • Dalian Municipal Central Hospital Affiliated of Dalian Medical University
  • Jiangsu Province Hospital
  • First Affiliated Hospital of Xi'an Jiaotong University
  • Shengli Oilfield Central Hospital
  • People's hospital of Rizhao
  • HuaShan Hospital Affiliated To Fudan University
  • West China Hospital of Sichuan University
  • No 1 Affiliate Hospital of Kunming Medical College
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • The First Affiliated Hospital of Wenzhou Medical College
  • Baotou Central Hospital
  • Peking Union Medical College Hospital
  • Chinese PLA General Hospital
  • The First Affiliated Hospital of Harbin Medical University
  • Tianjin Medical University General Hospital
  • Clintrial, s.r.o.
  • Neurologicka ambulance, Neurologie Brno s.r.o.
  • Brain-Soultherapy s.r.o
  • DADO MEDICAL, s.r.o.
  • Neurologicka ordinace
  • Neurologicka ambulance Prerov
  • CCBR-Alborg-DK
  • Glostrup Hospital
  • Center for Clinical and Basic Research -CCBR
  • APHM Hôpital de la Timone
  • Centre Hospitalier Annecy Genevois - Site d'Annecy
  • Hopital Lariboisière
  • CHU de Rouen Hopital Charles Nicolle
  • CHU St Etienne Hopital Nord
  • Synexus Clinical Research GmbH
  • DRK-Kliniken Nordhessen
  • Gemeinschaftspraxis für Neurologie und Psychiatrie
  • Praxis Dr. Philipp Stude
  • Synexus Clinical Research GmbH
  • DataMed Klinische Studien GmbH
  • Praxis für Neurologie und Psychiatrie
  • Synexus Clinical Research GmbH
  • Universitätsklinikum Jena
  • Charité Universitätsmedizin Berlin
  • Synexus Clinical Research GmbH
  • Neurologische Praxis Eppendorf
  • PANAKEIA - Arzneimittelforschung Leipzig GmbH
  • Valeomed Kft.
  • SE Neurologiai Klinika
  • Orszagos Idegtudomanyi Intezet
  • Nizam's Institute of Medical Sciences
  • Apollo Hospitals International Ltd.
  • Artemis Hospital
  • M S Ramaiah Medical College Hospital
  • Mangala Hospitals & Mangala Kidney Foundation
  • Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.
  • HCG Manavata Cancer Centre
  • Deenanth Mangeshkar Hospital and Research Centre
  • Gobind Ballabh Pant Hospital
  • Sir Ganga Ram Hospital
  • Istituto Neurologico Neuromed
  • Ospedale Bellaria
  • Istituto Neurologico Carlo Besta
  • Fondazione Istituto Neurologico Nationale C. Mondino
  • Clinical Research Institute S C
  • Clinstile, S.A de C.V
  • CRI Centro Regiomontano de Investigacion S.C.
  • Hospital Universitario Dr. Jose Eleuterio Gonzalez
  • Medical Care and Research, S.A. de C.V.
  • Instituto de Investigaciones Aplicadas a la Neurociencia A.C
  • Eci Estudios Clinicos Int.
  • Centro de Atención e Investigación Cardiovascular del Potosí S.C.
  • Canisius-Wilhelmina Ziekenhuis
  • Boerhaave Medisch Centrum
  • Isala Klinieken
  • First Moscow State Medical University n.a. Sechenov
  • University Headache Clinic
  • Medis Priokskiy
  • Saint Petersburg State Medical University n.a. Pavlov I.P.
  • Hospital Universitari de Bellvitge
  • Hospital Universitario Marques De Valdecilla
  • Clinica Universitaria De Navarra
  • Hospital Universitari Vall d'Hebron
  • Hospital Universitario La Paz
  • Hospital Universitario Virgen del Rocio
  • Hospital Clínico Universitario de Valencia
  • Hospital Universitario La Fe de Valencia
  • Hospital Clinico Universitario de Valladolid
  • H.C.U. Lozano Blesa
  • Kantonsspital Luzern
  • Kantonsspital St. Gallen
  • KopfwehZentrum Hirslanden Zürich
  • Rehaclinic Bad Zurzach
  • Inselspital Bern
  • Synexus Thames Valley Clinical Research Centre
  • Hull Royal Infirmary
  • Kings College Hospital
  • Re-Cognition Health Ltd
  • Synexus Manchester Clinical Research Centre
  • Synexus Lancashire Clinical Research Centre
  • Synexus Merseyside Clinical Research Centre
  • Synexus Hexham General Hospital
  • Queen Elizabeth University Hospital
  • Synexus Wales Clinical Research Centre
  • Synexus Scotland Clinical Research Centre
  • Re-Cognition Health Ltd
  • Re-Cognition Health Ltd
  • Synexus Midlands Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Experimental

Arm Label

100 milligram (mg) Lasmiditan

200 mg Lasmiditan

Control 1 Sequence

Control 2 Sequence

100 mg Lasmiditan Maximum Extended Enrollment (MEE)

200 mg Lasmiditan MEE

Control 1 Sequence MEE

Control 2 Sequence MEE

Open Label Extension

Arm Description

Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.

Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.

Control 1: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.

Control 2: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.

Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.

Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.

Control 1: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.

Control 2: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 4. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.

Participants initially received 100 mg Lasmiditan at the first OLE visit, with flexible dosing (50, 100, or 200 mg) thereafter to optimize efficacy and tolerability.

Outcomes

Primary Outcome Measures

Percentage of Participants That Are Pain Free 2 Hours Postdose During the First Attack
Pain-free is defined as mild, moderate, or severe headache pain becoming none at 2 hours postdose during the first attack.
Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 2 Out of 3 Attacks
To evaluate the 2 out of 3 primary consistency endpoint, the results of ITT evaluable attacks in the lasmiditan 100-mg and 200-mg groups will be assessed, and the ITT-evaluable attacks treated with placebo in the control group will be used for comparison. For participants with more than 3 ITT evaluable attacks, only the first 3 will be considered. Pain-free was defined as mild, moderate, or severe headache pain becoming none at the indicated assessment time.

Secondary Outcome Measures

Percentage of Participants With Pain Relief at 2 Hours Post Dose During the First Attack
Headache pain-relief is defined as a reduction in pain severity from moderate or severe at baseline to mild or none, or a reduction in pain severity from mild at baseline to none, at the indicated assessment time.
Percentage of Participants With Pain Relief at 2 Hours Postdose in at Least 2 Out of 3 Attacks
Headache pain relief is defined as a reduction in pain severity from moderate to severe at baseline to mild or none at 2 hours postdose in at least 2 out of 3 attacks. To evaluate at least 2 out of 3 consistency endpoints, the results of ITT-evaluable attacks in the lasmiditan 100-mg and 200-mg groups will be assessed, and the ITT-evaluable attacks treated with placebo in the control group will be used for comparison. For participants with more than 3 ITT-evaluable attacks, only the first 3 with the same treatment will be considered.
Percentage of Participants With 24-Hour Sustained Pain Freedom During the First Attack
Sustained pain freedom defined as pain free at 2 and 24 hours with no rescue medication.
Percentage of Participants With 48-Hour Sustained Pain Freedom During First Attack
Sustained pain freedom defined as pain free at 2 and 48 hours with no rescue medication.
Percentage of Participants That Are Pain Free 2 Hours Postdose During the First Attack in Triptan Insufficient Responders.
Pain-free is defined as mild, moderate, or severe headache pain becoming none at 2 hours postdose during the first attack. A triptan insufficient responder is defined as having one of the following: 1) Scoring ≤5 on 4 questions from the Migraine Treatment Optimization Questionnaire (mTOQ-6) that defines participants with poor or very poor response to their current regimen; 2) Indicated they obtained pain freedom at 2 hours in 0 out of 3, or 1 out of 3 attacks when treated with the most recent triptan, or 3) are not currently taking triptan and discontinued their most recent triptan due to lack of efficacy, tolerability issue, or contradictions to a past triptan.
Percentage of Participants With no Disability as Measured by the Disability Item, at 2 Hours Postdose During the First Attack
Percentage of participants with no disability as measured by the disability item, at 2 hours postdose during the first attack. Disability was measured by determining the level of interference with normal activities with 4 response options including not at all; mild interference, marked interference; and need complete bed rest.
Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 2 Out of 3 Attacks in Triptan Insufficient Responders
Headache pain-free is defined as a reduction in pain severity from mild, moderate, or severe at baseline to none at the indicated assessment time. A subject is not counted as being pain-free at a specific time point if she or he used rescue or recurrence medication at or before the specific time point.
Percentage of Participants Free of Most Bothersome Symptom (MBS) Associated With Migraine at 2 Hours Postdose During the First Attack
MBS freedom is defined as the absence of the associated symptom of migraine (nausea, phonophobia, or photophobia) at the indicated assessment time that was identified at baseline as the most bothersome symptom.
Percentage of Participants Requiring Rescue Medication for Migraine Within 24 Hours of Treatment During the First Attack
Percentage of participants requiring rescue medication for migraine within 2 to 24 hours of treatment during the first attack
Percentage of Participants That Are Free of Symptoms Associated With Migraine at 2 Hours Postdose During the First Attack
Percentage of participants that are free of symptoms associated with migraine (photophobia, phonophobia, nausea, and vomiting) at 2 hours postdose during the first attack.
Percentage of Participants With Migraine Recurrence at 24 Hours During the First Attack
Percentage of participants with migraine recurrence at 24 hours during the first attack defined as return of any headache in participants who were pain free at 2 hours.
Percentage of Participants With Pain Freedom, Pain Relief, Freedom From MBS, and No Disability Postdose During First Attack
Percentage of participants with pain freedom, pain relief, freedom from MBS, and no disability postdose during first attack.
Change From Baseline in Total Score as Measured by the Migraine Disability Assessment Test (MIDAS) Scale
The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of 5 items that reflect the number of days reported as missed, or with reduced productivity at work or home and social events. Each question is answered as the number of days during the past 3 months of assessment, ranging from 0 to 90, with the total score being the summation of the 5 numeric responses. A higher value is indicative of more disability.
Percentage of Participants Very Much or Much Better as Measured by Patient Global Impression of Change (PGI-C), at 2 Hours Postdose During the First Attack
The PGI-C is a one-item questionnaire that asks participants to provide their impression of change since taking the medicine. The PGI-C is measured using a 7-point Likert scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Reported are participants whose combined impression of change since taking the medicine was very much better and much better at 2 hours postdose.
Migraine Quality of Life Questionnaire (MQoLQ) Score at 24 Hours Post First Dose of Study During First Attack
The 24-hour Migraine Quality of Life Questionnaire (24-hr MQoLQ) has been specifically developed to measure the HRQoL of participants with migraine within a 24-hour period after having taken migraine medication A domain score is calculated by summing the responses to the 3 questions and the domain score ranges from 3 to 21, with lower scores indicating less impairment. The questionnaire will be administered 24 hours after dosing with study drug during each migraine. The analysis of variance (ANOVA) model was used with region and treatment adjusted for the overall treatment effect.
Percentage of Participants Satisfied With Their Treatment Measured by a 4-Item Questionnaire
Treatment satisfaction was evaluated at the End of Study (EoS) visit by determining the participant's level of satisfaction (ranging from extremely dissatisfied to extremely satisfied); their willingness to take this treatment again (ranging from strongly disagree to strongly agree) and if they would they recommend this treatment to another participants (ranging from strongly disagree to strongly agree).
Change From Baseline in Utility at 24 Hours Postdose as Measured by the EuroQol 5-Dimension 5-Level Scale (EQ-5D-5L) at 24 Hours Postdose During First Attack
The EQ-5D-5L questionnaire is a participant-rated scale that assesses health status, it consists of 2 parts. The first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 5 possible levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems).The EQ-5D can be used to generate a health state index score, which is used to compute quality-adjusted life years for utilization in health economic analyses. The health state index score is calculated based on the responses to the 5 dimensions, providing a single value on a scale from less than 0 (where 0 is a health state equivalent to death) to 1 (perfect health), with higher scores indicating better health utility. ANCOVA was used to assess the effect of Lasmiditan over placebo or control. The model includes fixed categorical effect of treatment and geographic region and baseline as covariate.
Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 3 Out of 4 Attacks
Headache pain-free is defined as a reduction in pain severity from mild, moderate, or severe to none at the indicated assessment time (2 hours postdose). To evaluate 3 out of 4 consistency endpoints; all ITT-evaluable attacks will be used. For the control group, the results of all ITT-evaluable attacks treated with lasmiditan 50 mg or placebo will be included. The control group is used for comparison. The population for 3 out of 4 consistency endpoints with sufficient number of successes or failures is defined as all participants who experienced at least 3 successes or 2 failures during ITT-evaluable attacks.
Percentage of Participants With Pain Relief at 2 Hours Postdose in at Least 3 Out of 4 Attacks
Headache pain-relief is defined as a reduction in pain severity from moderate or severe at baseline to mild or none, or a reduction in pain severity from mild at baseline to none, at the indicated assessment time (2 hours postdose). To evaluate 3 out of 4 consistency endpoints; all ITT-evaluable attacks will be used. For the control group, the results of all ITT-evaluable attacks treated with lasmiditan 50 mg or placebo will be included. The control group is used for comparison. The population for 3 out of 4 consistency endpoints with sufficient number of successes or failures is defined as all participants who experienced at least 3 successes or 2 failures during ITT-evaluable attacks.
Percentage of Participants With Associated Migraines Symptoms of Nausea, Vomiting, Photophobia, and Phonophobia Present at 2 Hours Postdose for First Attack
Presence of associated migraine symptoms at 2 hours postdose at first migraine attack, including each of the following: phonophobia, photophobia, nausea, and vomiting.

Full Information

First Posted
September 12, 2018
Last Updated
June 29, 2022
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03670810
Brief Title
A Study of Lasmiditan (LY573144) Over Four Migraine Attacks
Official Title
Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
June 12, 2020 (Actual)
Study Completion Date
July 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The reason for this study is to see how effective and safe the study drug known as lasmiditan is in the acute treatment of 4 migraine attacks with or without aura.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
acute treatment, migraine pain, multiple attacks, headache

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1633 (Actual)

8. Arms, Groups, and Interventions

Arm Title
100 milligram (mg) Lasmiditan
Arm Type
Experimental
Arm Description
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
Arm Title
200 mg Lasmiditan
Arm Type
Experimental
Arm Description
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
Arm Title
Control 1 Sequence
Arm Type
Placebo Comparator
Arm Description
Control 1: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
Arm Title
Control 2 Sequence
Arm Type
Placebo Comparator
Arm Description
Control 2: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
Arm Title
100 mg Lasmiditan Maximum Extended Enrollment (MEE)
Arm Type
Experimental
Arm Description
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
Arm Title
200 mg Lasmiditan MEE
Arm Type
Experimental
Arm Description
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
Arm Title
Control 1 Sequence MEE
Arm Type
Placebo Comparator
Arm Description
Control 1: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
Arm Title
Control 2 Sequence MEE
Arm Type
Placebo Comparator
Arm Description
Control 2: Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3. Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 4. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
Arm Title
Open Label Extension
Arm Type
Experimental
Arm Description
Participants initially received 100 mg Lasmiditan at the first OLE visit, with flexible dosing (50, 100, or 200 mg) thereafter to optimize efficacy and tolerability.
Intervention Type
Drug
Intervention Name(s)
Lasmiditan
Other Intervention Name(s)
LY573144
Intervention Description
Administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally.
Primary Outcome Measure Information:
Title
Percentage of Participants That Are Pain Free 2 Hours Postdose During the First Attack
Description
Pain-free is defined as mild, moderate, or severe headache pain becoming none at 2 hours postdose during the first attack.
Time Frame
2 Hours Postdose
Title
Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 2 Out of 3 Attacks
Description
To evaluate the 2 out of 3 primary consistency endpoint, the results of ITT evaluable attacks in the lasmiditan 100-mg and 200-mg groups will be assessed, and the ITT-evaluable attacks treated with placebo in the control group will be used for comparison. For participants with more than 3 ITT evaluable attacks, only the first 3 will be considered. Pain-free was defined as mild, moderate, or severe headache pain becoming none at the indicated assessment time.
Time Frame
2 Hours Postdose
Secondary Outcome Measure Information:
Title
Percentage of Participants With Pain Relief at 2 Hours Post Dose During the First Attack
Description
Headache pain-relief is defined as a reduction in pain severity from moderate or severe at baseline to mild or none, or a reduction in pain severity from mild at baseline to none, at the indicated assessment time.
Time Frame
2 Hours Postdose
Title
Percentage of Participants With Pain Relief at 2 Hours Postdose in at Least 2 Out of 3 Attacks
Description
Headache pain relief is defined as a reduction in pain severity from moderate to severe at baseline to mild or none at 2 hours postdose in at least 2 out of 3 attacks. To evaluate at least 2 out of 3 consistency endpoints, the results of ITT-evaluable attacks in the lasmiditan 100-mg and 200-mg groups will be assessed, and the ITT-evaluable attacks treated with placebo in the control group will be used for comparison. For participants with more than 3 ITT-evaluable attacks, only the first 3 with the same treatment will be considered.
Time Frame
2 Hours Postdose
Title
Percentage of Participants With 24-Hour Sustained Pain Freedom During the First Attack
Description
Sustained pain freedom defined as pain free at 2 and 24 hours with no rescue medication.
Time Frame
24 Hours
Title
Percentage of Participants With 48-Hour Sustained Pain Freedom During First Attack
Description
Sustained pain freedom defined as pain free at 2 and 48 hours with no rescue medication.
Time Frame
48 Hours Postdose
Title
Percentage of Participants That Are Pain Free 2 Hours Postdose During the First Attack in Triptan Insufficient Responders.
Description
Pain-free is defined as mild, moderate, or severe headache pain becoming none at 2 hours postdose during the first attack. A triptan insufficient responder is defined as having one of the following: 1) Scoring ≤5 on 4 questions from the Migraine Treatment Optimization Questionnaire (mTOQ-6) that defines participants with poor or very poor response to their current regimen; 2) Indicated they obtained pain freedom at 2 hours in 0 out of 3, or 1 out of 3 attacks when treated with the most recent triptan, or 3) are not currently taking triptan and discontinued their most recent triptan due to lack of efficacy, tolerability issue, or contradictions to a past triptan.
Time Frame
2 Hours Postdose
Title
Percentage of Participants With no Disability as Measured by the Disability Item, at 2 Hours Postdose During the First Attack
Description
Percentage of participants with no disability as measured by the disability item, at 2 hours postdose during the first attack. Disability was measured by determining the level of interference with normal activities with 4 response options including not at all; mild interference, marked interference; and need complete bed rest.
Time Frame
2 Hours Postdose
Title
Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 2 Out of 3 Attacks in Triptan Insufficient Responders
Description
Headache pain-free is defined as a reduction in pain severity from mild, moderate, or severe at baseline to none at the indicated assessment time. A subject is not counted as being pain-free at a specific time point if she or he used rescue or recurrence medication at or before the specific time point.
Time Frame
2 Hours Postdose
Title
Percentage of Participants Free of Most Bothersome Symptom (MBS) Associated With Migraine at 2 Hours Postdose During the First Attack
Description
MBS freedom is defined as the absence of the associated symptom of migraine (nausea, phonophobia, or photophobia) at the indicated assessment time that was identified at baseline as the most bothersome symptom.
Time Frame
2 Hours Postdose
Title
Percentage of Participants Requiring Rescue Medication for Migraine Within 24 Hours of Treatment During the First Attack
Description
Percentage of participants requiring rescue medication for migraine within 2 to 24 hours of treatment during the first attack
Time Frame
24 Hours
Title
Percentage of Participants That Are Free of Symptoms Associated With Migraine at 2 Hours Postdose During the First Attack
Description
Percentage of participants that are free of symptoms associated with migraine (photophobia, phonophobia, nausea, and vomiting) at 2 hours postdose during the first attack.
Time Frame
2 Hours Postdose
Title
Percentage of Participants With Migraine Recurrence at 24 Hours During the First Attack
Description
Percentage of participants with migraine recurrence at 24 hours during the first attack defined as return of any headache in participants who were pain free at 2 hours.
Time Frame
24 Hours
Title
Percentage of Participants With Pain Freedom, Pain Relief, Freedom From MBS, and No Disability Postdose During First Attack
Description
Percentage of participants with pain freedom, pain relief, freedom from MBS, and no disability postdose during first attack.
Time Frame
30 Minutes (Min) and 1 Hour (Hr) Postdose
Title
Change From Baseline in Total Score as Measured by the Migraine Disability Assessment Test (MIDAS) Scale
Description
The MIDAS is a participant-rated scale which was designed to quantify headache-related disability over a 3-month period. This instrument consists of 5 items that reflect the number of days reported as missed, or with reduced productivity at work or home and social events. Each question is answered as the number of days during the past 3 months of assessment, ranging from 0 to 90, with the total score being the summation of the 5 numeric responses. A higher value is indicative of more disability.
Time Frame
Baseline, Week 16
Title
Percentage of Participants Very Much or Much Better as Measured by Patient Global Impression of Change (PGI-C), at 2 Hours Postdose During the First Attack
Description
The PGI-C is a one-item questionnaire that asks participants to provide their impression of change since taking the medicine. The PGI-C is measured using a 7-point Likert scale, with 1 = very much better, 2 = much better, 3 = a little better, 4 = no change, 5 = a little worse, 6 = much worse, and 7 = very much worse. Reported are participants whose combined impression of change since taking the medicine was very much better and much better at 2 hours postdose.
Time Frame
2 Hours Postdose
Title
Migraine Quality of Life Questionnaire (MQoLQ) Score at 24 Hours Post First Dose of Study During First Attack
Description
The 24-hour Migraine Quality of Life Questionnaire (24-hr MQoLQ) has been specifically developed to measure the HRQoL of participants with migraine within a 24-hour period after having taken migraine medication A domain score is calculated by summing the responses to the 3 questions and the domain score ranges from 3 to 21, with lower scores indicating less impairment. The questionnaire will be administered 24 hours after dosing with study drug during each migraine. The analysis of variance (ANOVA) model was used with region and treatment adjusted for the overall treatment effect.
Time Frame
24 Hours Post First Dose
Title
Percentage of Participants Satisfied With Their Treatment Measured by a 4-Item Questionnaire
Description
Treatment satisfaction was evaluated at the End of Study (EoS) visit by determining the participant's level of satisfaction (ranging from extremely dissatisfied to extremely satisfied); their willingness to take this treatment again (ranging from strongly disagree to strongly agree) and if they would they recommend this treatment to another participants (ranging from strongly disagree to strongly agree).
Time Frame
Week 16
Title
Change From Baseline in Utility at 24 Hours Postdose as Measured by the EuroQol 5-Dimension 5-Level Scale (EQ-5D-5L) at 24 Hours Postdose During First Attack
Description
The EQ-5D-5L questionnaire is a participant-rated scale that assesses health status, it consists of 2 parts. The first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 5 possible levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems).The EQ-5D can be used to generate a health state index score, which is used to compute quality-adjusted life years for utilization in health economic analyses. The health state index score is calculated based on the responses to the 5 dimensions, providing a single value on a scale from less than 0 (where 0 is a health state equivalent to death) to 1 (perfect health), with higher scores indicating better health utility. ANCOVA was used to assess the effect of Lasmiditan over placebo or control. The model includes fixed categorical effect of treatment and geographic region and baseline as covariate.
Time Frame
Baseline, 24 Hours Postdose
Title
Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 3 Out of 4 Attacks
Description
Headache pain-free is defined as a reduction in pain severity from mild, moderate, or severe to none at the indicated assessment time (2 hours postdose). To evaluate 3 out of 4 consistency endpoints; all ITT-evaluable attacks will be used. For the control group, the results of all ITT-evaluable attacks treated with lasmiditan 50 mg or placebo will be included. The control group is used for comparison. The population for 3 out of 4 consistency endpoints with sufficient number of successes or failures is defined as all participants who experienced at least 3 successes or 2 failures during ITT-evaluable attacks.
Time Frame
2 Hours Postdose
Title
Percentage of Participants With Pain Relief at 2 Hours Postdose in at Least 3 Out of 4 Attacks
Description
Headache pain-relief is defined as a reduction in pain severity from moderate or severe at baseline to mild or none, or a reduction in pain severity from mild at baseline to none, at the indicated assessment time (2 hours postdose). To evaluate 3 out of 4 consistency endpoints; all ITT-evaluable attacks will be used. For the control group, the results of all ITT-evaluable attacks treated with lasmiditan 50 mg or placebo will be included. The control group is used for comparison. The population for 3 out of 4 consistency endpoints with sufficient number of successes or failures is defined as all participants who experienced at least 3 successes or 2 failures during ITT-evaluable attacks.
Time Frame
2 Hours Postdose
Title
Percentage of Participants With Associated Migraines Symptoms of Nausea, Vomiting, Photophobia, and Phonophobia Present at 2 Hours Postdose for First Attack
Description
Presence of associated migraine symptoms at 2 hours postdose at first migraine attack, including each of the following: phonophobia, photophobia, nausea, and vomiting.
Time Frame
2 Hours Postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1 History of disabling migraine for at least 1 year Migraine onset before the age of 50 years History of 3 to 8 migraine attacks per month (<15 headache days per month) during the past 3 months MIDAS score ≥11 Able and willing to complete an eDiary to record the details of each migraine attack treated with study drug Women of child-bearing potential must be using or willing to use a highly effective form of contraception Agree not to post any personal medical data or information related to the study on any website or social media site until the entire trial has completed Exclusion Criteria: Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets History or evidence of hemorrhagic stroke, epilepsy, or any other condition placing the participant at increased risk of seizures History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo, Meniere's disease, vestibular migraine, and other vestibular disorders History of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy) History of orthostatic hypotension with syncope Significant renal or hepatic impairment in the opinion of the investigator or if they meet hepatic monitoring criteria Participants who, in the investigator's judgment, are actively suicidal and therefore deemed to be at significant risk for suicide History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (eg, hemicranias continua, medication overuse headache where headache frequency is ≥15 headache days per month) Use of more than 3 doses per month of either opioids or barbiturates Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within 3 months prior to screening Pregnant or breast-feeding women History of drug or alcohol abuse/dependence within 1 year prior to screening Any medical condition or clinical laboratory test which in the judgment of the investigator makes the participant unsuitable for the study Currently enrolled in any other clinical study involving an investigational product Relatives of, or staff directly reporting to, the Investigator Participants who are employees of the sponsor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Rehabilitation & Neurological Services LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
UCSD Altman Clinical & Translational Research Institute (ACTRI)
City
La Jolla
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Colorado Neurological Institute
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
George Washington University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Diamond Headache Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60642
Country
United States
Facility Name
Ochsner Medical Center - North Shore
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
StudyMetrix Research, LLC
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63303
Country
United States
Facility Name
Nevada Headache Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113-2237
Country
United States
Facility Name
Dent Neurological Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Montefiore Headache Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Island Neuro Associates,PC
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007-4209
Country
United States
Facility Name
KH der Barmherzigen Schwestern Linz BetriebsGesmbH
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4010
Country
Austria
Facility Name
Universitätsklinik Innsbruck
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Christian-Doppler-Klinik
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
AKH
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Jessa Ziekenhuis
City
Hasselt
State/Province
Limburg
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Algemeen Ziekenhuis St Jan Brugge
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Universitair Ziekenhuis Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
CHC MontLégia
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Valdor - ISOSL CCV - Clinique des céphalées du Valdor - Neurology
City
Liege
ZIP/Postal Code
4020
Country
Belgium
Facility Name
Beijing Tiantan Hospital Affiliated to Capital Medical Univ
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Xuanwu Hospital-Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
The First Affiliated Hospital Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400030
Country
China
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Facility Name
The University of Hong Kong-Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518053
Country
China
Facility Name
Hebei General Hospital
City
ShiJiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Facility Name
First hospital affiliated to Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Wuhan Union (Xiehe) Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
The First Affliated Hospital of Suzhou University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Facility Name
Affiliated Hospital of Jiangsu University
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212001
Country
China
Facility Name
First Affiliated Hospital of Gannan Medical University
City
Ganzhou
State/Province
Jiangxi
ZIP/Postal Code
341000
Country
China
Facility Name
Pingxiang People's Hospital
City
Pingxiang
State/Province
Jiangxi
Country
China
Facility Name
No.2 Hospital Affiliated to Jilin University
City
Changchun City
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Facility Name
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116033
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Shengli Oilfield Central Hospital
City
Dongying
State/Province
Shandong
ZIP/Postal Code
257034
Country
China
Facility Name
People's hospital of Rizhao
City
Rizhao
State/Province
Shandong
ZIP/Postal Code
276826
Country
China
Facility Name
HuaShan Hospital Affiliated To Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
20040
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
No 1 Affiliate Hospital of Kunming Medical College
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
The First Affiliated Hospital of Wenzhou Medical College
City
WenZhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Facility Name
Baotou Central Hospital
City
Baotou
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
100853
Country
China
Facility Name
The First Affiliated Hospital of Harbin Medical University
City
Harbin
Country
China
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Clintrial, s.r.o.
City
Praha 10
State/Province
Hl. M. Praha
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
Neurologicka ambulance, Neurologie Brno s.r.o.
City
Brno
ZIP/Postal Code
616 00
Country
Czechia
Facility Name
Brain-Soultherapy s.r.o
City
Kladno
ZIP/Postal Code
27201
Country
Czechia
Facility Name
DADO MEDICAL, s.r.o.
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Neurologicka ordinace
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
Neurologicka ambulance Prerov
City
Prerov
ZIP/Postal Code
750 02
Country
Czechia
Facility Name
CCBR-Alborg-DK
City
Alborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Glostrup Hospital
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Center for Clinical and Basic Research -CCBR
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
APHM Hôpital de la Timone
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Centre Hospitalier Annecy Genevois - Site d'Annecy
City
Metz-Tessy
ZIP/Postal Code
74374
Country
France
Facility Name
Hopital Lariboisière
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
CHU de Rouen Hopital Charles Nicolle
City
Rouen Cedex
ZIP/Postal Code
76036
Country
France
Facility Name
CHU St Etienne Hopital Nord
City
Saint Etienne Cedex 2
ZIP/Postal Code
42000
Country
France
Facility Name
Synexus Clinical Research GmbH
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60313
Country
Germany
Facility Name
DRK-Kliniken Nordhessen
City
Kassel
State/Province
Hessen
ZIP/Postal Code
34121
Country
Germany
Facility Name
Gemeinschaftspraxis für Neurologie und Psychiatrie
City
Westerstede
State/Province
Niedersachsen
ZIP/Postal Code
26655
Country
Germany
Facility Name
Praxis Dr. Philipp Stude
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44787
Country
Germany
Facility Name
Synexus Clinical Research GmbH
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44787
Country
Germany
Facility Name
DataMed Klinische Studien GmbH
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50935
Country
Germany
Facility Name
Praxis für Neurologie und Psychiatrie
City
Essen
State/Province
North Rhine-Westphalia
ZIP/Postal Code
45133
Country
Germany
Facility Name
Synexus Clinical Research GmbH
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
State/Province
Thüringen
ZIP/Postal Code
07747
Country
Germany
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Synexus Clinical Research GmbH
City
Berlin
ZIP/Postal Code
12627
Country
Germany
Facility Name
Neurologische Praxis Eppendorf
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
PANAKEIA - Arzneimittelforschung Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04275
Country
Germany
Facility Name
Valeomed Kft.
City
Esztergom
State/Province
Komarom-Esztergom
ZIP/Postal Code
2500
Country
Hungary
Facility Name
SE Neurologiai Klinika
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Orszagos Idegtudomanyi Intezet
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Nizam's Institute of Medical Sciences
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500082
Country
India
Facility Name
Apollo Hospitals International Ltd.
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
382428
Country
India
Facility Name
Artemis Hospital
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122001
Country
India
Facility Name
M S Ramaiah Medical College Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560054
Country
India
Facility Name
Mangala Hospitals & Mangala Kidney Foundation
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575003
Country
India
Facility Name
Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400053
Country
India
Facility Name
HCG Manavata Cancer Centre
City
Nasik
State/Province
Maharashtra
ZIP/Postal Code
422001
Country
India
Facility Name
Deenanth Mangeshkar Hospital and Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Gobind Ballabh Pant Hospital
City
New Delhi
ZIP/Postal Code
110002
Country
India
Facility Name
Sir Ganga Ram Hospital
City
New Delhi
ZIP/Postal Code
110060
Country
India
Facility Name
Istituto Neurologico Neuromed
City
Pozzilli
State/Province
Isernia
ZIP/Postal Code
86077
Country
Italy
Facility Name
Ospedale Bellaria
City
Bologna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Istituto Neurologico Carlo Besta
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Fondazione Istituto Neurologico Nationale C. Mondino
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Clinical Research Institute S C
City
Tlalnepantla
State/Province
Edo De Mex
ZIP/Postal Code
54055
Country
Mexico
Facility Name
Clinstile, S.A de C.V
City
Cuauhtemoc
State/Province
Federal District
ZIP/Postal Code
06700
Country
Mexico
Facility Name
CRI Centro Regiomontano de Investigacion S.C.
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64060
Country
Mexico
Facility Name
Hospital Universitario Dr. Jose Eleuterio Gonzalez
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Medical Care and Research, S.A. de C.V.
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Instituto de Investigaciones Aplicadas a la Neurociencia A.C
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Facility Name
Eci Estudios Clinicos Int.
City
Puebla
ZIP/Postal Code
72160
Country
Mexico
Facility Name
Centro de Atención e Investigación Cardiovascular del Potosí S.C.
City
San Luis Potosi
ZIP/Postal Code
78200
Country
Mexico
Facility Name
Canisius-Wilhelmina Ziekenhuis
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6532 SZ
Country
Netherlands
Facility Name
Boerhaave Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1078 VV
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
First Moscow State Medical University n.a. Sechenov
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
University Headache Clinic
City
Moscow
ZIP/Postal Code
121467
Country
Russian Federation
Facility Name
Medis Priokskiy
City
Nizhny Novgorod
ZIP/Postal Code
603137
Country
Russian Federation
Facility Name
Saint Petersburg State Medical University n.a. Pavlov I.P.
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Hospital Universitari de Bellvitge
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario Marques De Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
Clinica Universitaria De Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital Clínico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitario La Fe de Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Clinico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47010
Country
Spain
Facility Name
H.C.U. Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Kantonsspital Luzern
City
Luzern 16
State/Province
Luzern
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
KopfwehZentrum Hirslanden Zürich
City
Zollikon
State/Province
Zurich
ZIP/Postal Code
8702
Country
Switzerland
Facility Name
Rehaclinic Bad Zurzach
City
Bad Zurzach
ZIP/Postal Code
5330
Country
Switzerland
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Synexus Thames Valley Clinical Research Centre
City
Reading
State/Province
Berkshire
ZIP/Postal Code
RG2 0TG
Country
United Kingdom
Facility Name
Hull Royal Infirmary
City
Hull
State/Province
East Yorkshire
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
State/Province
Greater London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Re-Cognition Health Ltd
City
London
State/Province
Greater London
ZIP/Postal Code
W1G 9JF
Country
United Kingdom
Facility Name
Synexus Manchester Clinical Research Centre
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M15 6SX
Country
United Kingdom
Facility Name
Synexus Lancashire Clinical Research Centre
City
Chorley
State/Province
Lancashire
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
Facility Name
Synexus Merseyside Clinical Research Centre
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L22 0LG
Country
United Kingdom
Facility Name
Synexus Hexham General Hospital
City
Hexham
State/Province
Northumberland
ZIP/Postal Code
NE46 1QJ
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Synexus Wales Clinical Research Centre
City
Cardiff
State/Province
South Glamorgan
ZIP/Postal Code
CF15 9SS
Country
United Kingdom
Facility Name
Synexus Scotland Clinical Research Centre
City
Glasgow
State/Province
Strathclyde
ZIP/Postal Code
G20 0SP
Country
United Kingdom
Facility Name
Re-Cognition Health Ltd
City
Guildford
State/Province
Surrey
ZIP/Postal Code
GU2 7YD
Country
United Kingdom
Facility Name
Re-Cognition Health Ltd
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B16 8LT
Country
United Kingdom
Facility Name
Synexus Midlands Clinical Research Center
City
Birmingham
State/Province
Wstmid
ZIP/Postal Code
B15 2SQ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/
Citations:
PubMed Identifier
36114949
Citation
Zhou J, Luo G, Xu Y, Yang X, Pan X, Dong Z, Zhong S, Liu H, Ji F, Yu S. 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. Adv Ther. 2022 Nov;39(11):5229-5243. doi: 10.1007/s12325-022-02291-2. Epub 2022 Sep 17.
Results Reference
derived
PubMed Identifier
35979677
Citation
MacGregor EA, Komori M, Krege JH, Baygani S, Vincent M, Pavlovic J, Igarashi H. Efficacy of lasmiditan for the acute treatment of perimenstrual migraine. Cephalalgia. 2022 Dec;42(14):1467-1475. doi: 10.1177/03331024221118929. Epub 2022 Aug 18.
Results Reference
derived
PubMed Identifier
35779194
Citation
Doty EG, Hauck PM, Krege JH, Komori M, Hake AM, Dong Y, Lipton RB. The Association Between the Occurrence of Common Treatment-Emergent Adverse Events and Efficacy Outcomes After Lasmiditan Treatment of a Single Migraine Attack: Secondary Analyses from Four Pooled Randomized Clinical Trials. CNS Drugs. 2022 Jul;36(7):771-783. doi: 10.1007/s40263-022-00928-y. Epub 2022 Jul 2.
Results Reference
derived
PubMed Identifier
35713760
Citation
Yu T, He L, Yang X, Zhou J, Luo G, Wang H, Zhao H, Hu Q, Ji F, Yu S. Efficacy and Safety of Lasmiditan as a Novel Acute Treatment in Chinese Patients with Migraine: A Subpopulation Analysis of the Randomized Controlled Phase 3 CENTURION Trial. Neurol Ther. 2022 Sep;11(3):1269-1283. doi: 10.1007/s40120-022-00369-1. Epub 2022 Jun 17.
Results Reference
derived
PubMed Identifier
35471625
Citation
Krege JH, Lipton RB, Baygani SK, Komori M, Ryan SM, Vincent M. Lasmiditan for Patients with Migraine and Contraindications to Triptans: A Post Hoc Analysis. Pain Ther. 2022 Jun;11(2):701-712. doi: 10.1007/s40122-022-00388-8. Epub 2022 Apr 26.
Results Reference
derived
PubMed Identifier
34742230
Citation
Tassorelli C, Bragg S, Krege JH, Doty EG, Ardayfio PA, Ruff D, Dowsett SA, Schwedt T. Safety findings from CENTURION, a phase 3 consistency study of lasmiditan for the acute treatment of migraine. J Headache Pain. 2021 Nov 6;22(1):132. doi: 10.1186/s10194-021-01343-2.
Results Reference
derived
PubMed Identifier
34644189
Citation
Reuter U, Krege JH, Lombard L, Gomez Valderas E, Krikke-Workel J, Dell-Agnello G, Dowsett SA, Buse DC. Lasmiditan efficacy in the acute treatment of migraine was independent of prior response to triptans: Findings from the CENTURION study. Cephalalgia. 2022 Jan;42(1):20-30. doi: 10.1177/03331024211048507. Epub 2021 Oct 13.
Results Reference
derived
PubMed Identifier
33541117
Citation
Ashina M, Reuter U, Smith T, Krikke-Workel J, Klise SR, Bragg S, Doty EG, Dowsett SA, Lin Q, Krege JH. Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study. Cephalalgia. 2021 Mar;41(3):294-304. doi: 10.1177/0333102421989232. Epub 2021 Feb 4.
Results Reference
derived
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/45cVxLjssEICmyC0uECUa4
Description
A Study of Lasmiditan (LY573144) Over Four Migraine Attacks

Learn more about this trial

A Study of Lasmiditan (LY573144) Over Four Migraine Attacks

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