Phase 2
N=846
A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT03962738 ↗Enrolled (actual)
846
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Percentage of Participants Who Are Headache Pain Free In High Dose Group (200 mg Lasmiditan) — 16.6; 40.8 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lasmiditan (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Are Headache Pain Free In High Dose Group (200 mg Lasmiditan) |
16.6; 40.8 | <0.001 sig |
| SECONDARY Percentage of Participants Who Are Headache Pain Free in Each Dose Group |
16.6; 23.5; 32.4; 40.8 | <.001 sig |
| SECONDARY Percentage of Participants With Headache Pain Relief |
41.2; 35.3; 58.5; 59.8 | 0.343 |
| SECONDARY Percentage of Participants Who Are Free of Most Bothersome Symptoms (MBS) Associated With Migraine |
46.5; 55.9; 58.0; 60.3 | 0.197 |
| SECONDARY Percentage of Participants With 24-Hour Sustained Pain Freedom |
10.4; 14.9; 20.2; 23.2 | 0.268 |
| SECONDARY Percentage of Participants With 48-Hour Sustained Pain Freedom |
12.3; 14.9; 19.7; 21.1 | 0.535 |
| SECONDARY Percentage of Participants That Are Free of Phonophobia |
83.7; 89.5; 87.2; 86.5 | 0.199 |
| SECONDARY Percentage of Participants That Are Free of Photophobia |
69.2; 77.9; 76.8; 77.8 | 0.135 |
| SECONDARY Percentage of Participants That Are Free of Nausea |
78.8; 83.7; 82.3; 79.5 | 0.342 |
| SECONDARY Percentage of Participants That Are Free of Vomiting |
99.0; 97.7; 99.5; 100.0 | — |
| SECONDARY Percentage of Participants With Pain Freedom |
1.4; 4.7; 11.6; 12.8 | 0.112 |
| SECONDARY Percentage of Participants With Headache Pain Relief |
41.2; 35.3; 58.5; 59.8 | 0.343 |
| SECONDARY Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) |
28.7; 32.2; 42.0; 33.1 | 0.605 |
| SECONDARY Percentage of Participants With No Disability |
18.4; 24.7; 25.4; 28.7 | 0.233 |
| SECONDARY Percentage of Participants With No Disability |
18.4; 24.7; 25.4; 28.7 | 0.233 |
| SECONDARY Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Health Status Index Score Japan |
0.200; 0.192; 0.224; 0.186 | 0.724 |
| SECONDARY Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Visual Analog Scale |
20.785; 19.640; 21.341; 19.320 | 0.719 |
| SECONDARY Percentage of Participants With Very Much or Much Better as Measured by the Patient Global Impression of Change (PGI-C) |
23.6; 35.6; 44.7; 48.3 | 0.037 sig |
| SECONDARY Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) |
12.594; 13.392; 13.034; 12.368; 13.235; 13.865 | 0.162 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03962738). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.