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出境医 / 临床实验 / A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine (MONONOFU)
A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine (MONONOFU)
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Migraine | Drug: Lasmiditan Drug: Placebo | Phase 2 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 846 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | May 31, 2019 |
| Actual Primary Completion Date : | June 8, 2020 |
| Actual Study Completion Date : | June 8, 2020 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
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Experimental: 50 milligram (mg) Lasmiditan
50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
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Drug: Lasmiditan
Administered orally
Other Name: LY573144
Drug: Placebo Administered orally
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Experimental: 100 mg Lasmiditan
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
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Drug: Lasmiditan
Administered orally
Other Name: LY573144
Drug: Placebo Administered orally
|
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Experimental: 200 mg Lasmiditan
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
|
Drug: Lasmiditan
Administered orally
Other Name: LY573144
Drug: Placebo Administered orally
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Placebo Comparator: Placebo
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
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Drug: Placebo
Administered orally
|
Outcome Measures
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Percentage of Participants Who Are Headache Pain Free in Each Dose Group [ Time Frame: 2 Hours Postdose ]Percentage of participants who are headache pain free in each dose group at 2 hours postdose.
- Percentage of Participants With Headache Pain Relief [ Time Frame: 2 Hours Postdose ]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 [ Time Frame: 2 Hours Postdose ]
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 [ Time Frame: 24 Hours Postdose ]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 [ Time Frame: 48 Hours Postdose ]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 [ Time Frame: 2 Hours Postdose ]Percentage of participants that are free of phonophobia at 2 hours postdose.
- Percentage of Participants That Are Free of Photophobia [ Time Frame: 2 Hours Postdose ]Percentage of participants that are free of photophobia at 2 hours postdose.
- Percentage of Participants That Are Free of Nausea [ Time Frame: 2 Hours Postdose ]Percentage of participants that are free of nausea at 2 hours postdose.
- Percentage of Participants That Are Free of Vomiting [ Time Frame: 2 Hours Postdose ]Percentage of participants that are free of vomiting at 2 hours postdose.
- Percentage of Participants With Pain Freedom [ Time Frame: 1 Hour Postdose ]Percentage of participants with pain freedom.
- Percentage of Participants With Headache Pain Relief [ Time Frame: 1 Hour Postdose ]Percentage of participants with headache pain relief at 1 hour postdose.
- Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) [ Time Frame: 1 Hour Postdose ]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 [ Time Frame: 1 Hour Postdose ]
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 [ Time Frame: 2 Hours Postdose ]
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 [ Time Frame: 24 Hours Postdose ]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 [ Time Frame: 24 Hours Postdose ]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) [ Time Frame: 2 Hours Postdose ]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) [ Time Frame: 24 Hours Postdose ]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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Locations
Show 34 study locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | 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) | Eli Lilly and Company |
| Tracking Information | |||||||||||||||||
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| First Submitted Date ICMJE | May 23, 2019 | ||||||||||||||||
| First Posted Date ICMJE | May 24, 2019 | ||||||||||||||||
| Results First Submitted Date ICMJE | April 9, 2021 | ||||||||||||||||
| Results First Posted Date ICMJE | May 5, 2021 | ||||||||||||||||
| Last Update Posted Date | May 5, 2021 | ||||||||||||||||
| Actual Study Start Date ICMJE | May 31, 2019 | ||||||||||||||||
| Actual Primary Completion Date | June 8, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE |
Percentage of Participants who are Pain Free (High Dose) [ Time Frame: 2 Hours Postdose ] Percentage of Participants who are Pain Free (High Dose)
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| Change History | |||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine | ||||||||||||||||
| Official Title ICMJE | 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 | ||||||||||||||||
| 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. | ||||||||||||||||
| Detailed Description | Not Provided | ||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase ICMJE | Phase 2 | ||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Migraine | ||||||||||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||
| Actual Enrollment ICMJE |
846 | ||||||||||||||||
| Original Estimated Enrollment ICMJE |
880 | ||||||||||||||||
| Actual Study Completion Date ICMJE | June 8, 2020 | ||||||||||||||||
| Actual Primary Completion Date | June 8, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Listed Location Countries ICMJE | Japan | ||||||||||||||||
| Removed Location Countries | |||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT03962738 | ||||||||||||||||
| Other Study ID Numbers ICMJE | 17012 H8H-JE-LAIH ( Other Identifier: Eli Lilly and Company ) |
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| Has Data Monitoring Committee | No | ||||||||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Eli Lilly and Company | ||||||||||||||||
| Study Sponsor ICMJE | Eli Lilly and Company | ||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||
| Investigators ICMJE |
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| PRS Account | Eli Lilly and Company | ||||||||||||||||
| Verification Date | July 2020 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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