Trial · NCT02439320

Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:

NCT02439320, Phase 3, Completed, Eli Lilly and Company; results first posted 2019-11-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:. Trials, record NCT02439320. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02439320

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:
NCT number: NCT02439320
Status: Completed
Phases: Phase 3
Enrollment: 2,231 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Acute Migraine
Interventions: Lasmiditan 100 mg, Lasmiditan 200 mg, Placebo (matches lasmiditan doses)
First posted: 2015-05-08
Last updated: 2019-12-16
Results first posted: 2019-11-27

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 Who Are Headache Pain Free	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.
Secondary	Percentage of Participants Who Have Headache Relief After First Dose	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.
Secondary	Percentage of Participants With Headache Recurrence	From 2 hours post dose up to 48 hours	Participants who received study drug and which became pain free at 2 hours post-dose and worsened again up to 48 hours post-dose.
Secondary	Percentage of Participants Who Used Rescue Medication	2 hours post dose	Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
Secondary	Percentage of Participants Who Used Rescue Medication	Anytime between 2-24 hours post dose	Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
Secondary	Percentage of Participants Who Used Rescue Medication	Anytime 24-48 hours post dose	Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).
Secondary	Percentage of Participants Nausea Free	2 hours post dose	The percentage of participants without nausea.
Secondary	Percentage of Participants Phonophobia Free	2 hours post dose	The percentage of participants without phonophobia.
Secondary	Percentage of Participants Photophobia Free	2 hours post dose	The percentage of participants without photophobia.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants Who Are Headache Pain Free	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
SECONDARY	Percentage of Participants Who Have Headache Relief After First Dose	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
SECONDARY	Percentage of Participants With Headache Recurrence	From 2 hours post dose up to 48 hours	Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Used Rescue Medication	2 hours post dose	Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Used Rescue Medication	Anytime between 2-24 hours post dose	Randomized participants who received a dose of study drug and had postdose headache severity or symptom assessments.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Used Rescue Medication	Anytime 24-48 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
SECONDARY	Percentage of Participants Nausea Free	2 hours post dose	All randomized participants who used at least 1 dose of study drug and had any post-dose headache severity or symptom assessments.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Phonophobia Free	2 hours post dose	All randomized participants who used at least 1 dose of study drug and had any post-dose headache severity or symptom assessments.	percentage of participants	NUMBER
SECONDARY	Percentage of Participants 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 outcomes

Results by group43

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Percentage of Participants Who Are Headache Pain Free	100 mg Lasmiditan	28.2	percentage of participants
Percentage of Participants Who Are Headache Pain Free	200 mg Lasmiditan	32.2	percentage of participants
Percentage of Participants Who Are Headache Pain Free	Placebo	15.3	percentage of participants
Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free	100 mg Lasmiditan	40.9	percentage of participants
Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free	200 mg Lasmiditan	40.7	percentage of participants
Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free	Placebo	29.5	percentage of participants
Percentage of Participants Who Have Headache Relief After First Dose	100 mg Lasmiditan	59.4	percentage of participants
Percentage of Participants Who Have Headache Relief After First Dose	200 mg Lasmiditan	59.5	percentage of participants
Percentage of Participants Who Have Headache Relief After First Dose	Placebo	42.2	percentage of participants
Percentage of Participants With Headache Recurrence	100 mg Lasmiditan	8.4	percentage of participants

1 to 10 of 43Source ClinicalTrials.gov

See all 43 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	100 mg Lasmiditan	744
Overall Study	STARTED	200 mg Lasmiditan	745
Overall Study	STARTED	Placebo	742
Overall Study	Confirmed Eligibility	100 mg Lasmiditan	710
Overall Study	Confirmed Eligibility	200 mg Lasmiditan	695
Overall Study	Confirmed Eligibility	Placebo	705
Overall Study	1st Dose (by 4 Hours Migraine Onset)	100 mg Lasmiditan	630
Overall Study	1st Dose (by 4 Hours Migraine Onset)	200 mg Lasmiditan	609
Overall Study	1st Dose (by 4 Hours Migraine Onset)	Placebo	617
Overall Study	2nd Dose (After 2 Hour Assessment)	100 mg Lasmiditan	289

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events489

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	Angina pectoris	Cardiac disorders	100 mg Lasmiditan	1	630	1
other	Angina pectoris	Cardiac disorders	200 mg Lasmiditan	0	609	0
other	Angina pectoris	Cardiac disorders	Placebo	0	617	0
other	Bradycardia	Cardiac disorders	100 mg Lasmiditan	1	630	1
other	Bradycardia	Cardiac disorders	200 mg Lasmiditan	0	609	0
other	Bradycardia	Cardiac disorders	Placebo	1	617	1
other	Cardiac flutter	Cardiac disorders	100 mg Lasmiditan	0	630	0
other	Cardiac flutter	Cardiac disorders	200 mg Lasmiditan	0	609	0
other	Cardiac flutter	Cardiac disorders	Placebo	1	617	1
other	Left ventricular hypertrophy	Cardiac disorders	100 mg Lasmiditan	0	630	0

1 to 10 of 489Source ClinicalTrials.gov

See all 489 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	100 mg Lasmiditan	0	630
Total, all-cause mortality	200 mg Lasmiditan	0	609
Total, all-cause mortality	Placebo	0	617
Total, other adverse events	100 mg Lasmiditan	258	630
Total, other adverse events	200 mg Lasmiditan	280	609
Total, other adverse events	Placebo	113	617
Total, serious adverse events	100 mg Lasmiditan	0	630
Total, serious adverse events	200 mg Lasmiditan	2	609
Total, serious adverse events	Placebo	1	617

Source ClinicalTrials.gov

Papers20

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30446595	DERIVED	PubMed
31152441	DERIVED	PubMed
31166697	DERIVED	PubMed
31266353	DERIVED	PubMed
31340760	DERIVED	PubMed
31409292	DERIVED	PubMed
31464581	DERIVED	PubMed
31529622	DERIVED	PubMed
31744319	DERIVED	PubMed
32447545	DERIVED	PubMed

1 to 10 of 20

See all 20 papers

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02439320

GET https://conductscience.org/api/trials/v1/NCT02439320/results?page=2

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