MigrainePhase 2MONONOFUNCT03962738
A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine
A Phase 2 study testing Lasmiditan in people with Migraine, run by Eli Lilly and Company at 34 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Lasmiditan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 846 participants
- Where
- 34 sitesJapan
- Study dates
- 31 May 2019to 8 Jun 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
Japan34 sites
Niwa Family Clinic
Chofu-shi, Tokyo, 182-0006
Doi Clinic Internal Medicine Neurology
Hiroshima, 730-0031
Saitama Medical University Hospital
Iruma-Gun, Saitama, 350-0495
Tanaka neurosurgical clinic
Kagoshima, 892-0844
Nagaseki Headache Clinic
Kai-Shi, Yamanashi, 400-0124
Ikeda Neurosurgical Clinic
Kasuga-shi, Fukuoka, 816 0824
Jinnouchi Neurosurgery Clinic
Kasuga-shi, Fukuoka, 816-0802
Fujitsu Clinic
Kawasaki, Kanagawa, 211-8588
Kohnan Hospital
Kobe, Hyōgo, 658-0064
Umenotsuji Clinic
Kochi, 780-8011
Kumamoto City Hospital
Kumamoto, 862-8505
Tatsuoka Neurology Clinic
Kyoto, 600-8811
Ishikawa Clinic
Kyoto, 606-0851
Takanoko Hospital
Matsuyama, Ehime, 790-0925
Sanno Clinic Shinagawa
Minato-ku, Tokyo, 108-0075
Nishinomiya Municipal Central Hospital
Nishinomiya, Hyōgo, 663-8014
Yamaguchi Clinic
Nishinomiya-shi, Hyōgo, 663-8204
Okayama City General Medical Center Okayama City Hospital
Okayama, Okayama-ken, 700-8557
Chibune General Hospital
Osaka, Osaka, 555-0034
Osaka Saiseikai Nakatsu Hospital
Osaka, 530-0012
Tominaga Hospital
Osaka, 5560017
SUBARU Health Insurance Society Ota Memorial Hospital
Ota-shi, Gunma, 373-8585
Osoegawa Neurology Clinic
Saga, Saga-ken, 840-0806
Saitama Neuropsychiatric Institute
Saitama, Saitama, 338-8577
Nakamura Memorial Hospital
Sapporo, Hokkaido, 060 8570
Sendai Headache and Neurology Clinic
Sendai, Miyagi, 982-0014
USUDA CLINIC for internal medicine
Setagaya-ku, Tokyo, 156-0043
Tokyo Headache Clinic
Shibuya-ku, Tokyo, 151-0051
Dokkyo Medical University Hospital
Shimotsuga-Gun, Tochigi, 321 0293
Fukuuchi Pain Clinic
Shinjuku-ku, Tokyo, 160-0017
Japanese Red Cross Shizuoka Hospital
Shizuoka, 420-0853
Saino Clinic
Tokorozawa, Saitama, 359-1141
Sakura Clinic Internal Medicine Neurology
Toyama, Toyama, 9300803
Takase internal medicine clinic
Toyonaka-shi, Osaka, 560-0012
About this study
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
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.
- Conditions
- Migraine
- Being tested
- Lasmiditan, Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LasmiditanDrug
Also called LY573144
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| 50 milligram (mg) Lasmiditan | Experimental | 50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack. Receives: Drug: Lasmiditan; Drug: Placebo |
| 100 mg Lasmiditan | Experimental | 100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack. Receives: Drug: Lasmiditan; Drug: Placebo |
| 200 mg Lasmiditan | Experimental | 200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack. Receives: Drug: Lasmiditan; Drug: Placebo |
| Placebo | Placebo comparator | Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 Hours Postdose
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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."
Measured: 2 Hours Postdose
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.
Measured: 24 Hours Postdose
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.
Measured: 48 Hours Postdose
Percentage of Participants That Are Free of Phonophobia
Percentage of participants that are free of phonophobia at 2 hours postdose.
Measured: 2 Hours Postdose
Percentage of Participants That Are Free of Photophobia
Percentage of participants that are free of photophobia at 2 hours postdose.
Measured: 2 Hours Postdose
Percentage of Participants That Are Free of Nausea
Percentage of participants that are free of nausea at 2 hours postdose.
Measured: 2 Hours Postdose
Percentage of Participants That Are Free of Vomiting
Percentage of participants that are free of vomiting at 2 hours postdose.
Measured: 2 Hours Postdose
Percentage of Participants With Pain Freedom
Percentage of participants with pain freedom.
Measured: 1 Hour Postdose
Percentage of Participants With Headache Pain Relief
Percentage of participants with headache pain relief at 1 hour postdose.
Measured: 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.
Measured: 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.
Measured: 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 2 hours postdose.
Measured: 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.
Measured: Baseline, 24 Hours Postdose
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).
Measured: Baseline, 24 Hours Postdose
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.
Measured: 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.
Measured: 24 Hours Postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start31 May 2019
- Primary completion8 Jun 2020
- Study completion8 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 846 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962738
- Sponsor's protocol ID
- 17012
- Other IDs
- H8H-JE-LAIH
- Acronym
- MONONOFU
- Status last verified
- May 2021
- First submitted
- 23 May 2019
- Last updated
- 11 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Kitamura S, Imai N, Tanji Y, Ozeki A, Komori M. Lasmiditan in Japanese Patients with Common Migraine Comorbidities or Concomitant Medications: A Post Hoc Safety and Efficacy Analysis from the MONONOFU Study. J Pain Res. 2023 May 25;16:1725-1738. doi: 10.2147/JPR.S399567. eCollection 2023.
PubMed 37255987Matsumori 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.
PubMed 36136232MacGregor 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.
PubMed 35979677Doty 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.
PubMed 35779194Hashimoto 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.
PubMed 35748397Krege 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.
PubMed 35471625
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03962738
- Acronym / sponsor ID
- MONONOFU / 17012
- Conditions
- Migraine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 846 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 31 May 2019 (actual)
- Primary completion
- 8 Jun 2020 (actual)
- Study completion
- 8 Jun 2020 (actual)
- First posted
- 24 May 2019 (actual)
- Results
- Posted 5 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 50 milligram (mg) Lasmiditan | Experimental | Drug: Lasmiditan, Drug: Placebo50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack. |
| 100 mg Lasmiditan | Experimental | Drug: Lasmiditan, Drug: Placebo100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack. |
| 200 mg Lasmiditan | Experimental | Drug: Lasmiditan, Drug: Placebo200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LasmiditanAlso: LY573144Administered orally | Drug | 100 mg Lasmiditan, 200 mg Lasmiditan, 50 milligram (mg) Lasmiditan |
| PlaceboAdministered orally | Drug | 100 mg Lasmiditan, 200 mg Lasmiditan, 50 milligram (mg) Lasmiditan, Placebo |
Primary outcome
Percentage of Participants Who Are Headache Pain Free In High Dose Group (200 mg Lasmiditan)
Time frame: 2 Hours Postdose
Percentage of participants who were headache pain free (defined as moderate or severe pain becoming none) at 2 hours postdose.
18 secondary outcomes
Percentage of Participants Who Are Headache Pain Free in Each Dose Group
Time frame: 2 Hours Postdose
Percentage of Participants With Headache Pain Relief
Time frame: 2 Hours Postdose
Percentage of Participants Who Are Free of Most Bothersome Symptoms (MBS) Associated With Migraine
Time frame: 2 Hours Postdose
Percentage of Participants With 24-Hour Sustained Pain Freedom
Time frame: 24 Hours Postdose
Percentage of Participants With 48-Hour Sustained Pain Freedom
Time frame: 48 Hours Postdose
Percentage of Participants That Are Free of Phonophobia
Time frame: 2 Hours Postdose
Percentage of Participants That Are Free of Photophobia
Time frame: 2 Hours Postdose
Percentage of Participants That Are Free of Nausea
Time frame: 2 Hours Postdose
Percentage of Participants That Are Free of Vomiting
Time frame: 2 Hours Postdose
Percentage of Participants With Pain Freedom
Time frame: 1 Hour Postdose
Percentage of Participants With Headache Pain Relief
Time frame: 1 Hour Postdose
Percentage of Participants With Freedom From Most Bothersome Symptom (MBS)
Time frame: 1 Hour Postdose
Percentage of Participants With No Disability
Time frame: 1 Hour Postdose
Percentage of Participants With No Disability
Time frame: 2 Hours Postdose
Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Health Status Index Score Japan
Time frame: Baseline, 24 Hours Postdose
Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Visual Analog Scale
Time frame: Baseline, 24 Hours Postdose
Percentage of Participants With Very Much or Much Better as Measured by the Patient Global Impression of Change (PGI-C)
Time frame: 2 Hours Postdose
Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ)
Time frame: 24 Hours Postdose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37255987Kitamura S, Imai N, Tanji Y, Ozeki A, Komori M. Lasmiditan in Japanese Patients with Common Migraine Comorbidities or Concomitant Medications: A Post Hoc Safety and Efficacy Analysis from the MONONOFU Study. J Pain Res. 2023 May 25;16:1725-1738. doi: 10.2147/JPR.S399567. eCollection 2023.
- Derived from this study: PubMed 36136232Matsumori 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.
- Derived from this study: PubMed 35979677MacGregor 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.
- Derived from this study: PubMed 35779194Doty 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.
- Derived from this study: PubMed 35748397Hashimoto 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.
- Derived from this study: PubMed 35471625Krege 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lasmiditan in people with Migraine, run by Eli Lilly and Company at 34 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Are Headache Pain Free In High Dose Group (200 mg Lasmiditan) (time frame: 2 Hours Postdose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03962738, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.