Phase 3
N=1,633
A Study of Lasmiditan (LY573144) Over Four Migraine Attacks
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT03670810 ↗Enrolled (actual)
1,633
Serious AEs
2.0%
Results posted
Jul 2021
Primary outcome: Primary: Percentage of Participants That Are Pain Free 2 Hours Postdose During the First Attack — 25.8; 29.3; 8.4 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- 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 That Are Pain Free 2 Hours Postdose During the First Attack |
25.8; 29.3; 8.4 | <0.001 sig |
| PRIMARY Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 2 Out of 3 Attacks |
14.4; 24.4; 4.3 | <.001 sig |
| SECONDARY Percentage of Participants With Pain Relief at 2 Hours Post Dose During the First Attack |
65.4; 65.2; 41.3 | <0.001 sig |
| SECONDARY Percentage of Participants With Pain Relief at 2 Hours Postdose in at Least 2 Out of 3 Attacks |
62.3; 66.7; 36.9 | <0.001 sig |
| SECONDARY Percentage of Participants With 24-Hour Sustained Pain Freedom During the First Attack |
13.6; 17.3; 4.3 | <0.001 sig |
| SECONDARY Percentage of Participants With 48-Hour Sustained Pain Freedom During First Attack |
9.3; 15.4; 4.3 | 0.004 sig |
| SECONDARY Percentage of Participants That Are Pain Free 2 Hours Postdose During the First Attack in Triptan Insufficient Responders. |
24.0; 25.6; 8.8 | <0.001 sig |
| SECONDARY Percentage of Participants With no Disability as Measured by the Disability Item, at 2 Hours Postdose During the First Attack |
18.6; 19.8; 9.5 | <0.001 sig |
| SECONDARY Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 2 Out of 3 Attacks in Triptan Insufficient Responders |
11.0; 20.1; 4.3 | 0.031 sig |
| SECONDARY Percentage of Participants Free of Most Bothersome Symptom (MBS) Associated With Migraine at 2 Hours Postdose During the First Attack |
40.4; 39.0; 28.0 | <0.001 sig |
| SECONDARY Percentage of Participants Requiring Rescue Medication for Migraine Within 24 Hours of Treatment During the First Attack |
19.6; 19.2; 29.3 | <0.001 sig |
| SECONDARY Percentage of Participants That Are Free of Symptoms Associated With Migraine at 2 Hours Postdose During the First Attack |
17.9; 21.0; 7.2 | <0.001 sig |
| SECONDARY Percentage of Participants With Migraine Recurrence at 24 Hours During the First Attack |
30.6; 22.0; 37.8 | — |
| SECONDARY Percentage of Participants With Pain Freedom, Pain Relief, Freedom From MBS, and No Disability Postdose During First Attack |
1.4; 1.6; 0.2; 6.0; 12.7; 2.0 | 0.086 |
| SECONDARY Change From Baseline in Total Score as Measured by the Migraine Disability Assessment Test (MIDAS) Scale |
-10.7; -12.0; -13.1 | 0.092 |
| SECONDARY 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 |
29.8; 30.0; 13.3 | <0.001 sig |
| SECONDARY Migraine Quality of Life Questionnaire (MQoLQ) Score at 24 Hours Post First Dose of Study During First Attack |
12.4; 12.1; 11.7; 12.4; 12.5; 11.4 | 0.056 |
| SECONDARY Percentage of Participants Satisfied With Their Treatment Measured by a 4-Item Questionnaire |
57.2; 58.1; 52.0; 61.5; 58.9; 64.3 | 0.101 |
| SECONDARY 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 |
0.2499; 0.2270; 0.2122 | 0.142 |
| SECONDARY Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 3 Out of 4 Attacks |
7.4; 10.8; 2.6 | 0.004 sig |
| SECONDARY Percentage of Participants With Pain Relief at 2 Hours Postdose in at Least 3 Out of 4 Attacks |
40.8; 49.8; 21.8 | <0.001 sig |
| SECONDARY Percentage of Participants With Associated Migraines Symptoms of Nausea, Vomiting, Photophobia, and Phonophobia Present at 2 Hours Postdose for First Attack |
29.1; 29.0; 29.1; 26.7; 23.5; 40.6 | 0.953 |
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.
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
Data sourced from ClinicalTrials.gov (NCT03670810). 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.