Phase 3
Completed N=1,633
A Study of Lasmiditan (LY573144) Over Four Migraine Attacks
Source: ClinicalTrials.gov NCT03670810 ↗Enrolled (actual)
1,633
Serious AEs
2.0%
Results posted
Jul 2021
Primary outcomePrimary: 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
◆ Published Evidence
Established
26citations · ~13 / year
Long-term treatment with lasmiditan in patients with migraine: post hoc analysis of treatment patterns and outcomes from the open-label extension of the CENTURION randomized trial.
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.
Linked Publications (5)
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Long-term treatment with lasmiditan in patients with migraine: post hoc analysis of treatment patterns and outcomes from the open-label extension of the CENTURION randomized trial.
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Efficacy of lasmiditan for the acute treatment of perimenstrual migraine.
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Long-term treatment with lasmiditan in patients with migraine: Results from the open-label extension of the CENTURION randomized trial.
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Serotonin syndrome in the acute treatment landscape of migraine: the lasmiditan experience.
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Safety Findings in Lasmiditan as a Novel Acute Treatment of Migraine in Chinese Patients: A Post Hoc Analysis of the Randomized Controlled Phase 3 CENTURION Trial.
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 |
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) and the linked publication. 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. Informational only — not medical advice.