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A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine (MONONOFU)

Primary Purpose

Migraine

Status
Completed
Phase
Phase 2
Locations
Japan
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

Eligibility Criteria

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

Inclusion Criteria:

  • Participants with migraine with or without aura fulfilling the International Classification of Headache Disorders (ICHD)-2.
  • History of disabling migraine for at least 1 year.
  • Migraine Disability Assessment Test (MIDAS) score ≥11.
  • Migraine onset before the age of 50 years.
  • History of 3-8 migraine attacks per month and <15 headache days per month during the past 3 months.

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 patient 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.

Sites / Locations

  • Takanoko Hospital
  • Ikeda Neurosurgical Clinic
  • Jinnouchi Neurosurgery Clinic
  • SUBARU Health Insurance Society Ota Memorial Hospital
  • Nakamura Memorial Hospital
  • Kohnan Hospital
  • Yamaguchi Clinic
  • Nishinomiya Municipal Central Hospital
  • Fujitsu Clinic
  • Sendai Headache and Neurology Clinic
  • Okayama City General Medical Center Okayama City Hospital
  • Chibune General Hospital
  • Takase internal medicine clinic
  • Osoegawa Neurology Clinic
  • Saitama Medical University Hospital
  • Saitama Neuropsychiatric Institute
  • Saino Clinic
  • Dokkyo Medical University Hospital
  • Niwa Family Clinic
  • Sanno Clinic Shinagawa
  • USUDA CLINIC for internal medicine
  • Tokyo Headache Clinic
  • Fukuuchi Pain Clinic
  • Sakura Clinic Internal Medicine Neurology
  • Nagaseki Headache Clinic
  • Doi Clinic Internal Medicine Neurology
  • Tanaka neurosurgical clinic
  • Umenotsuji Clinic
  • Kumamoto City Hospital
  • Tatsuoka Neurology Clinic
  • Ishikawa Clinic
  • Osaka Saiseikai Nakatsu Hospital
  • Tominaga Hospital
  • Japanese Red Cross Shizuoka Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

50 milligram (mg) Lasmiditan

100 mg Lasmiditan

200 mg Lasmiditan

Placebo

Arm Description

50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.

100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.

200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.

Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.

Outcomes

Primary Outcome Measures

Percentage of Participants Who Are Headache Pain Free In High Dose Group (200 mg Lasmiditan)
Percentage of participants who were headache pain free (defined as moderate or severe pain becoming none) at 2 hours postdose.

Secondary Outcome Measures

Percentage of Participants Who Are Headache Pain Free in Each Dose Group
Percentage of participants who are headache pain free in each dose group at 2 hours postdose.
Percentage of Participants With Headache Pain Relief
Percentage of participants with headache pain relief (defined as moderate or severe headache pain becoming mild or none) at 2 hours postdose.
Percentage of Participants Who Are Free of Most Bothersome Symptoms (MBS) Associated With Migraine
Percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing and being absent at 2 hours postdose. Missing value at a particular time point was considered as "nonresponder."
Percentage of Participants With 24-Hour Sustained Pain Freedom
Percentage of participants who are headache pain free at 2 hours postdose and 24 hours postdose with no rescue medication.
Percentage of Participants With 48-Hour Sustained Pain Freedom
Percentage of participants who are headache pain free at 2 hours postdose and 48 hours postdose with no rescue medication.
Percentage of Participants That Are Free of Phonophobia
Percentage of participants that are free of phonophobia at 2 hours postdose.
Percentage of Participants That Are Free of Photophobia
Percentage of participants that are free of photophobia at 2 hours postdose.
Percentage of Participants That Are Free of Nausea
Percentage of participants that are free of nausea at 2 hours postdose.
Percentage of Participants That Are Free of Vomiting
Percentage of participants that are free of vomiting at 2 hours postdose.
Percentage of Participants With Pain Freedom
Percentage of participants with pain freedom.
Percentage of Participants With Headache Pain Relief
Percentage of participants with headache pain relief at 1 hour postdose.
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS)
Percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing and being absent at 1 hour postdose.
Percentage of Participants With No Disability
Disability will be measured by determining the level of interference with normal activities with 4 response options including: not at all (0); mild interference (1), marked interference (2); and need complete bed rest (3). No Disability timing is defined as the first time when severity becomes 0. Percentage of participants who are responders defined as score = 0 at 1 hours postdose.
Percentage of Participants With No Disability
Disability will be measured by determining the level of interference with normal activities with 4 response options including not at all (0); mild interference (1), marked interference (2); and need complete bed rest (3). No Disability timing is defined as the first time when severity becomes 0. Percentage of participants who are responders defined as score = 0 at 2 hours postdose.
Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Health Status Index Score Japan
The EQ-5D-5L was assessed based the EQ-5D-5L Health Status Index Score. The Japan specific tariffs (Japanese population-based index value) was used. The EQ-5D-5L is a participant rated, 2-part questionnaire. The first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The health state index score was 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; negative values are valued as worse than death) to 1 (perfect health), with higher scores indicating better health utility.
Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Visual Analog Scale
The EQ-5D-5L is a participant rated, 2-part questionnaire. The second part of the questionnaire consists of a visual analog scale on which the participant rates their perceived health state from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Percentage of Participants With Very Much or Much Better as Measured by the Patient Global Impression of Change (PGI-C)
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. Percentage of participants who are responders defined as having rated their impression of change as "very much better" or "much better" at 2 hours postdose.
Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ)
The HRQoL is a 15-item, self-administered questionnaire. The items cover 5 domains (work functioning, social functioning, energy and vitality, feelings and concerns, and migraine symptoms). Each domain consists of 3 questions answered on a 7-point scale there 1 indicates maximum impairment and 7 indicating no impairment. A domain score is calculated by summing the responses to the 3 questions and the domain score ranges from 3 to 21, where a lower score indicates greater impairment, and a higher score indicates less impairment. The questionnaire will be administered 24 hours after the study drug.

Full Information

First Posted
May 23, 2019
Last Updated
May 17, 2021
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03962738
Brief Title
A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine
Acronym
MONONOFU
Official Title
RandoMized, DOuble-bliNd, PlacebO-coNtrolled Trial Of Lasmiditan in a Single Migraine Attack in Japanese Patients SuFfering From Migraine With or WithoUt Aura - the MONONOFU Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 31, 2019 (Actual)
Primary Completion Date
June 8, 2020 (Actual)
Study Completion Date
June 8, 2020 (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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will assess the efficacy and safety of lasmiditan in the acute treatment of a migraine attack in Japanese adult participants with or without aura.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
846 (Actual)

8. Arms, Groups, and Interventions

Arm Title
50 milligram (mg) Lasmiditan
Arm Type
Experimental
Arm Description
50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
Arm Title
100 mg Lasmiditan
Arm Type
Experimental
Arm Description
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
Arm Title
200 mg Lasmiditan
Arm Type
Experimental
Arm Description
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
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 Who Are Headache Pain Free In High Dose Group (200 mg Lasmiditan)
Description
Percentage of participants who were headache pain free (defined as moderate or severe pain becoming none) at 2 hours postdose.
Time Frame
2 Hours Postdose
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Are Headache Pain Free in Each Dose Group
Description
Percentage of participants who are headache pain free in each dose group at 2 hours postdose.
Time Frame
2 Hours Postdose
Title
Percentage of Participants With Headache Pain Relief
Description
Percentage of participants with headache pain relief (defined as moderate or severe headache pain becoming mild or none) at 2 hours postdose.
Time Frame
2 Hours Postdose
Title
Percentage of Participants Who Are Free of Most Bothersome Symptoms (MBS) Associated With Migraine
Description
Percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing and being absent at 2 hours postdose. Missing value at a particular time point was considered as "nonresponder."
Time Frame
2 Hours Postdose
Title
Percentage of Participants With 24-Hour Sustained Pain Freedom
Description
Percentage of participants who are headache pain free at 2 hours postdose and 24 hours postdose with no rescue medication.
Time Frame
24 Hours Postdose
Title
Percentage of Participants With 48-Hour Sustained Pain Freedom
Description
Percentage of participants who are headache pain free at 2 hours postdose and 48 hours postdose with no rescue medication.
Time Frame
48 Hours Postdose
Title
Percentage of Participants That Are Free of Phonophobia
Description
Percentage of participants that are free of phonophobia at 2 hours postdose.
Time Frame
2 Hours Postdose
Title
Percentage of Participants That Are Free of Photophobia
Description
Percentage of participants that are free of photophobia at 2 hours postdose.
Time Frame
2 Hours Postdose
Title
Percentage of Participants That Are Free of Nausea
Description
Percentage of participants that are free of nausea at 2 hours postdose.
Time Frame
2 Hours Postdose
Title
Percentage of Participants That Are Free of Vomiting
Description
Percentage of participants that are free of vomiting at 2 hours postdose.
Time Frame
2 Hours Postdose
Title
Percentage of Participants With Pain Freedom
Description
Percentage of participants with pain freedom.
Time Frame
1 Hour Postdose
Title
Percentage of Participants With Headache Pain Relief
Description
Percentage of participants with headache pain relief at 1 hour postdose.
Time Frame
1 Hour Postdose
Title
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS)
Description
Percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing and being absent at 1 hour postdose.
Time Frame
1 Hour Postdose
Title
Percentage of Participants With No Disability
Description
Disability will be measured by determining the level of interference with normal activities with 4 response options including: not at all (0); mild interference (1), marked interference (2); and need complete bed rest (3). No Disability timing is defined as the first time when severity becomes 0. Percentage of participants who are responders defined as score = 0 at 1 hours postdose.
Time Frame
1 Hour Postdose
Title
Percentage of Participants With No Disability
Description
Disability will be measured by determining the level of interference with normal activities with 4 response options including not at all (0); mild interference (1), marked interference (2); and need complete bed rest (3). No Disability timing is defined as the first time when severity becomes 0. Percentage of participants who are responders defined as score = 0 at 2 hours postdose.
Time Frame
2 Hours Postdose
Title
Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Health Status Index Score Japan
Description
The EQ-5D-5L was assessed based the EQ-5D-5L Health Status Index Score. The Japan specific tariffs (Japanese population-based index value) was used. The EQ-5D-5L is a participant rated, 2-part questionnaire. The first part assesses 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) that have 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The health state index score was 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; negative values are valued as worse than death) to 1 (perfect health), with higher scores indicating better health utility.
Time Frame
Baseline, 24 Hours Postdose
Title
Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Visual Analog Scale
Description
The EQ-5D-5L is a participant rated, 2-part questionnaire. The second part of the questionnaire consists of a visual analog scale on which the participant rates their perceived health state from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Time Frame
Baseline, 24 Hours Postdose
Title
Percentage of Participants With Very Much or Much Better as Measured by the Patient Global Impression of Change (PGI-C)
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. Percentage of participants who are responders defined as having rated their impression of change as "very much better" or "much better" at 2 hours postdose.
Time Frame
2 Hours Postdose
Title
Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ)
Description
The HRQoL is a 15-item, self-administered questionnaire. The items cover 5 domains (work functioning, social functioning, energy and vitality, feelings and concerns, and migraine symptoms). Each domain consists of 3 questions answered on a 7-point scale there 1 indicates maximum impairment and 7 indicating no impairment. A domain score is calculated by summing the responses to the 3 questions and the domain score ranges from 3 to 21, where a lower score indicates greater impairment, and a higher score indicates less impairment. The questionnaire will be administered 24 hours after the study drug.
Time Frame
24 Hours Postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants with migraine with or without aura fulfilling the International Classification of Headache Disorders (ICHD)-2. History of disabling migraine for at least 1 year. Migraine Disability Assessment Test (MIDAS) score ≥11. Migraine onset before the age of 50 years. History of 3-8 migraine attacks per month and <15 headache days per month during the past 3 months. 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 patient 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.
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
Takanoko Hospital
City
Matsuyama-shi
State/Province
Ehime
ZIP/Postal Code
790-0925
Country
Japan
Facility Name
Ikeda Neurosurgical Clinic
City
Kasuga-shi
State/Province
Fukuoka
ZIP/Postal Code
816 0824
Country
Japan
Facility Name
Jinnouchi Neurosurgery Clinic
City
Kasuga-shi
State/Province
Fukuoka
ZIP/Postal Code
816-0802
Country
Japan
Facility Name
SUBARU Health Insurance Society Ota Memorial Hospital
City
Ota-shi
State/Province
Gunma
ZIP/Postal Code
373-8585
Country
Japan
Facility Name
Nakamura Memorial Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060 8570
Country
Japan
Facility Name
Kohnan Hospital
City
Kobe
State/Province
Hyogo
ZIP/Postal Code
658-0064
Country
Japan
Facility Name
Yamaguchi Clinic
City
Nishinomiya-shi
State/Province
Hyogo
ZIP/Postal Code
663-8204
Country
Japan
Facility Name
Nishinomiya Municipal Central Hospital
City
Nishinomiya
State/Province
Hyogo
ZIP/Postal Code
663-8014
Country
Japan
Facility Name
Fujitsu Clinic
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
211-8588
Country
Japan
Facility Name
Sendai Headache and Neurology Clinic
City
Sendai
State/Province
Miyagi
ZIP/Postal Code
982-0014
Country
Japan
Facility Name
Okayama City General Medical Center Okayama City Hospital
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
700-8557
Country
Japan
Facility Name
Chibune General Hospital
City
Osaka-City
State/Province
Osaka
ZIP/Postal Code
555-0034
Country
Japan
Facility Name
Takase internal medicine clinic
City
Toyonaka-shi
State/Province
Osaka
ZIP/Postal Code
560-0012
Country
Japan
Facility Name
Osoegawa Neurology Clinic
City
Saga-shi
State/Province
Saga
ZIP/Postal Code
840-0806
Country
Japan
Facility Name
Saitama Medical University Hospital
City
Iruma-Gun
State/Province
Saitama
ZIP/Postal Code
350-0495
Country
Japan
Facility Name
Saitama Neuropsychiatric Institute
City
Saitama City
State/Province
Saitama
ZIP/Postal Code
338-8577
Country
Japan
Facility Name
Saino Clinic
City
Tokorozawa
State/Province
Saitama
ZIP/Postal Code
359-1141
Country
Japan
Facility Name
Dokkyo Medical University Hospital
City
Shimotsuga-Gun
State/Province
Tochigi
ZIP/Postal Code
321 0293
Country
Japan
Facility Name
Niwa Family Clinic
City
Chofu-shi
State/Province
Tokyo
ZIP/Postal Code
182-0006
Country
Japan
Facility Name
Sanno Clinic Shinagawa
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-0075
Country
Japan
Facility Name
USUDA CLINIC for internal medicine
City
Setagaya-ku
State/Province
Tokyo
ZIP/Postal Code
156-0043
Country
Japan
Facility Name
Tokyo Headache Clinic
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
151-0051
Country
Japan
Facility Name
Fukuuchi Pain Clinic
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0017
Country
Japan
Facility Name
Sakura Clinic Internal Medicine Neurology
City
Toyama-Shi
State/Province
Toyama
ZIP/Postal Code
9300803
Country
Japan
Facility Name
Nagaseki Headache Clinic
City
Kai-Shi
State/Province
Yamanashi
ZIP/Postal Code
400-0124
Country
Japan
Facility Name
Doi Clinic Internal Medicine Neurology
City
Hiroshima
ZIP/Postal Code
730-0031
Country
Japan
Facility Name
Tanaka neurosurgical clinic
City
Kagoshima
ZIP/Postal Code
892-0844
Country
Japan
Facility Name
Umenotsuji Clinic
City
Kochi
ZIP/Postal Code
780-8011
Country
Japan
Facility Name
Kumamoto City Hospital
City
Kumamoto
ZIP/Postal Code
862-8505
Country
Japan
Facility Name
Tatsuoka Neurology Clinic
City
Kyoto
ZIP/Postal Code
600-8811
Country
Japan
Facility Name
Ishikawa Clinic
City
Kyoto
ZIP/Postal Code
606-0851
Country
Japan
Facility Name
Osaka Saiseikai Nakatsu Hospital
City
Osaka
ZIP/Postal Code
530-0012
Country
Japan
Facility Name
Tominaga Hospital
City
Osaka
ZIP/Postal Code
5560017
Country
Japan
Facility Name
Japanese Red Cross Shizuoka Hospital
City
Shizuoka
ZIP/Postal Code
420-0853
Country
Japan

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
https://vivli.org/
Citations:
PubMed Identifier
36136232
Citation
Matsumori Y, Komori M, Tanji Y, Ozeki A, Sakai F. Rapid Onset and Sustained Efficacy of Lasmiditan Among Japanese Patients with Migraine: Prespecified Analyses of a Randomized Controlled Trial. Neurol Ther. 2022 Dec;11(4):1721-1734. doi: 10.1007/s40120-022-00403-2. Epub 2022 Sep 22.
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
35748397
Citation
Hashimoto Y, Komori M, Tanji Y, Ozeki A, Hirata K. Lasmiditan for single migraine attack in Japanese patients with cardiovascular risk factors: subgroup analysis of a phase 2 randomized placebo-controlled trial. Expert Opin Drug Saf. 2022 Dec;21(12):1495-1503. doi: 10.1080/14740338.2022.2078302. Epub 2022 Jun 24.
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

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A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine

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