Trial · NCT02605174
Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine
NCT02605174, Phase 3, Completed, Eli Lilly and Company; results first posted 2018-07-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine. Trials, record NCT02605174. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02605174
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine
- NCT number
- NCT02605174
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,005 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Migraine With or Without Aura
- Interventions
- Lasmiditan 50 mg, Lasmiditan 100 mg, Lasmiditan 200 mg, Placebo
- First posted
- 2015-11-16
- Last updated
- 2019-09-23
- Other registries' IDs
- eudract:2015-005689-40
- Results first posted
- 2018-07-30
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Headache Pain Free at 2 Hours Post Dose | 2 hours post dose | The percentage of participants defined as mild, moderate, or severe headache pain becoming none. |
| Primary | Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free | 2 hours post dose | The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent. |
| Other | Percentage of Participants With Headache Relief | 2 hours post dose | The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none. |
| Other | Number of Participants With Headache Recurrence | From 2 Hours Post Dose Up to 48 Hours | The number of participants with headache recurrence (moderate or severe at baseline which became pain-free at 2 hours post dose and worsened again up to 48 hours post dose) |
| Other | Percentage of Participants Use of Rescue Medication | 2 hours post dose | The percentage of participants who used rescue medication. |
| Other | Percentage of Participants Use of Rescue Medication | From 2 Hours Post Dose Up to 24 Hours | The percentage of participants who used rescue medication. |
| Other | Percentage of Participants Use of Rescue Medication | From 24 Post Dose Up to 48 Hours | The percentage of participants who used rescue medication. |
| Other | Percentage of Participants Nausea Free | 2 hours post dose | The percentage of participant without nausea. |
| Other | Percentage of Participants With Phonophobia Free | 2 hours post dose | The percentage of participants without phonophobia. |
| Other | Percentage of Participants With Photophobia Free | 2 hours post dose | The percentage of participants without photophobia. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Headache Pain Free at 2 Hours Post Dose | 2 hours post dose | All randomized participants who received at least one dose of study drug and had evaluable headache pain free data. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free | 2 hours post dose | All randomized participants who received at least one dose of study drug and had evaluable MBS data. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Headache Relief | 2 hours post dose | All randomized participants who received at least one dose of study drug and had evaluable headache relief data. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Headache Recurrence | From 2 Hours Post Dose Up to 48 Hours | All randomized participants who received at least one dose of study drug and had evaluable headache recurrence data. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Percentage of Participants Use of Rescue Medication | 2 hours post dose | All randomized participants who received at least one dose of study drug and had evaluable use of rescue medication data. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants Use of Rescue Medication | From 2 Hours Post Dose Up to 24 Hours | All randomized participants who received at least one dose of study drug and had evaluable use of rescue medication data. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants Use of Rescue Medication | From 24 Post Dose Up to 48 Hours | All randomized participants who received at least one dose of study drug and had evaluable use of rescue medication data. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants Nausea Free | 2 hours post dose | All randomized participants who received at least one dose of study drug and had evaluable nausea free data. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Phonophobia Free | 2 hours post dose | All randomized participants who received at least one dose of study drug and had evaluable phonophobia free data. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Photophobia Free | 2 hours post dose | All randomized participants who received at least one dose of study drug and had evaluable photophobia free data. | percentage of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group58
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Headache Pain Free at 2 Hours Post Dose | Lasmiditan 50 mg | 28.6 | percentage of participants | ||
| Percentage of Participants Headache Pain Free at 2 Hours Post Dose | Lasmiditan 100 mg | 31.4 | percentage of participants | ||
| Percentage of Participants Headache Pain Free at 2 Hours Post Dose | Lasmiditan 200 mg | 38.8 | percentage of participants | ||
| Percentage of Participants Headache Pain Free at 2 Hours Post Dose | Placebo | 21.3 | percentage of participants | ||
| Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free | Lasmiditan 50 mg | 40.8 | percentage of participants | ||
| Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free | Lasmiditan 100 mg | 44.2 | percentage of participants | ||
| Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free | Lasmiditan 200 mg | 48.7 | percentage of participants | ||
| Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free | Placebo | 33.5 | percentage of participants | ||
| Percentage of Participants With Headache Relief | Lasmiditan 50 mg | 59.0 | percentage of participants | ||
| Percentage of Participants With Headache Relief | Lasmiditan 100 mg | 64.8 | percentage of participants |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 results by groupParticipant flow35
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lasmiditan 50 Milligram (mg)/Lasmiditan 50 mg | 501 | |
| Overall Study | STARTED | Lasmiditan 50 mg/Placebo | 249 | |
| Overall Study | STARTED | Lasmiditan 100 mg/Lasmiditan 100 mg | 502 | |
| Overall Study | STARTED | Lasmitidan 100 mg/Placebo | 252 | |
| Overall Study | STARTED | Lasmiditan 200 mg/Lasmiditan 200 mg | 501 | |
| Overall Study | STARTED | Lasmitidan 200 mg/Placebo | 249 | |
| Overall Study | STARTED | Placebo/Placebo | 751 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Lasmiditan 50 Milligram (mg)/Lasmiditan 50 mg | 429 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Lasmiditan 50 mg/Placebo | 225 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Lasmiditan 100 mg/Lasmiditan 100 mg | 423 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 participant flowAdverse events1,155
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | Lasmiditan 50 mg/Lasmiditan 50 mg | 3 | 429 | 4 |
| other | Palpitations | Cardiac disorders | Lasmiditan 50 mg/Placebo | 0 | 225 | 0 |
| other | Palpitations | Cardiac disorders | Lasmiditan 100 mg/Lasmiditan 100 mg | 1 | 423 | 1 |
| other | Palpitations | Cardiac disorders | Lasmiditan 100 mg/Placebo | 1 | 212 | 1 |
| other | Palpitations | Cardiac disorders | Lasmiditan 200 mg/Lasmiditan 200 mg | 1 | 435 | 1 |
| other | Palpitations | Cardiac disorders | Lasmiditan 200 mg/Placebo | 1 | 217 | 2 |
| other | Palpitations | Cardiac disorders | Placebo/Placebo | 1 | 646 | 1 |
| other | Tachycardia | Cardiac disorders | Lasmiditan 50 mg/Lasmiditan 50 mg | 0 | 429 | 0 |
| other | Tachycardia | Cardiac disorders | Lasmiditan 50 mg/Placebo | 1 | 225 | 1 |
| other | Tachycardia | Cardiac disorders | Lasmiditan 100 mg/Lasmiditan 100 mg | 2 | 423 | 2 |
1 to 10 of 1,155Source ClinicalTrials.gov
See all 1,155 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lasmiditan 50 mg/Lasmiditan 50 mg | 0 | 429 |
| Total, all-cause mortality | Lasmiditan 50 mg/Placebo | 0 | 225 |
| Total, all-cause mortality | Lasmiditan 100 mg/Lasmiditan 100 mg | 0 | 423 |
| Total, all-cause mortality | Lasmiditan 100 mg/Placebo | 0 | 212 |
| Total, all-cause mortality | Lasmiditan 200 mg/Lasmiditan 200 mg | 0 | 435 |
| Total, all-cause mortality | Lasmiditan 200 mg/Placebo | 0 | 217 |
| Total, all-cause mortality | Placebo/Placebo | 0 | 646 |
| Total, other adverse events | Lasmiditan 50 mg/Lasmiditan 50 mg | 118 | 429 |
| Total, other adverse events | Lasmiditan 50 mg/Placebo | 61 | 225 |
| Total, other adverse events | Lasmiditan 100 mg/Lasmiditan 100 mg | 149 | 423 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers19
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02605174
GET https://conductscience.org/api/trials/v1/NCT02605174/results?page=2