Trial · NCT02565186
An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine
NCT02565186, Phase 3, Completed, Eli Lilly and Company; results first posted 2020-08-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine. Trials, record NCT02565186. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02565186
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-label, Long-term, Safety Study of Lasmiditan for the Acute Treatment of Migraine
- NCT number
- NCT02565186
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,171 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Migraine Disorders
- Interventions
- Lasmiditan
- First posted
- 2015-10-01
- Last updated
- 2020-08-25
- Other registries' IDs
- eudract:2015-005674-37
- Results first posted
- 2020-08-25
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With at Least 1 Treatment Emergent Adverse Event | Up to 12 months | An AE with an onset on or within 48 hours after a dose of study drug, or an event that worsened in intensity within 48 hours of a dose of study drug was considered a treatment-emergent adverse event (TEAE). A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module. |
| Secondary | Percentage of Migraine Attacks With Pain Freedom (PF) at 2 Hours After Dose | Up to 12 months | Pain freedom is defined as a reduction in headache severity from mild (1), moderate (2), or severe (3) at baseline to none (0). |
| Secondary | Percentage of Migraine Attacks With Most Bothersome Symptom-Free (MBS) at 2 Hours After Dose | Up to 12 months | MBS-free, defined as the absence of the associated symptom of migraine (nausea, phonophobia, and/or photophobia) at 2 hours postdose that was identified predose as the most bothersome symptom. |
| Other | Percentage of Participants With Medical Resource Utilization | Up to 12 months | Medical Resource utilization for any cardiovascular (CV) events and/or related resource utilization, such as visits to cardiologists, procedures, hospitalizations, new treatments or treatment adjustments for CV disease and any visits to an emergency room (ER) or physician's office for treatment of migraine was reported. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With at Least 1 Treatment Emergent Adverse Event | Up to 12 months | All randomized participants who received at least one dose of study drug. | Participants | NUMBER |
| SECONDARY | Percentage of Migraine Attacks With Pain Freedom (PF) at 2 Hours After Dose | Up to 12 months | All randomized participants who treated at least 1 qualifying migraine attack within 4 hours of onset. | Percentage of PF Migraine Attacks | NUMBER |
| SECONDARY | Percentage of Migraine Attacks With Most Bothersome Symptom-Free (MBS) at 2 Hours After Dose | Up to 12 months | All randomized participants who treated at least 1 qualifying migraine attack within 4 hours of onset. | Percentage of MBS-Free Migraine Attacks | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Medical Resource Utilization | Up to 12 months | All randomized participants who received at least one dose of study drug. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With at Least 1 Treatment Emergent Adverse Event | Lasmiditan 100mg | 447 | Participants | ||
| Number of Participants With at Least 1 Treatment Emergent Adverse Event | Lasmiditan 200mg | 545 | Participants | ||
| Percentage of Migraine Attacks With Pain Freedom (PF) at 2 Hours After Dose | Lasmiditan 100mg | 26.7 | Percentage of PF Migraine Attacks | ||
| Percentage of Migraine Attacks With Pain Freedom (PF) at 2 Hours After Dose | Lasmiditan 200mg | 32.2 | Percentage of PF Migraine Attacks | ||
| Percentage of Migraine Attacks With Most Bothersome Symptom-Free (MBS) at 2 Hours After Dose | Lasmiditan 100mg | 37.2 | Percentage of MBS-Free Migraine Attacks | ||
| Percentage of Migraine Attacks With Most Bothersome Symptom-Free (MBS) at 2 Hours After Dose | Lasmiditan 200mg | 40.8 | Percentage of MBS-Free Migraine Attacks | ||
| Percentage of Participants With Medical Resource Utilization | Lasmiditan 100mg | Visit to cardiologist | 0.6 | Percentage of Participants | |
| Percentage of Participants With Medical Resource Utilization | Lasmiditan 200mg | Visit to cardiologist | 0.6 | Percentage of Participants | |
| Percentage of Participants With Medical Resource Utilization | Lasmiditan 100mg | Visit to primary care | 0.8 | Percentage of Participants | |
| Percentage of Participants With Medical Resource Utilization | Lasmiditan 200mg | Visit to primary care | 0.9 | Percentage of Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lasmiditan 100mg | 1,046 | |
| Overall Study | STARTED | Lasmiditan 200mg | 1,125 | |
| Overall Study | Received at Least One Dose of Study Drug | Lasmiditan 100mg | 991 | |
| Overall Study | Received at Least One Dose of Study Drug | Lasmiditan 200mg | 1,039 | |
| Overall Study | COMPLETED | Lasmiditan 100mg | 466 | |
| Overall Study | COMPLETED | Lasmiditan 200mg | 504 | |
| Overall Study | NOT COMPLETED | Lasmiditan 100mg | 580 | |
| Overall Study | NOT COMPLETED | Lasmiditan 200mg | 621 |
Source ClinicalTrials.gov
Adverse events724
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 | Anaemia | Blood and lymphatic system disorders | Lasmiditan 100mg | 2 | 991 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Lasmiditan 200mg | 1 | 1,039 | 1 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Lasmiditan 100mg | 0 | 991 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Lasmiditan 200mg | 1 | 1,039 | 1 |
| other | Bundle branch block left | Cardiac disorders | Lasmiditan 100mg | 1 | 991 | 1 |
| other | Bundle branch block left | Cardiac disorders | Lasmiditan 200mg | 0 | 1,039 | 0 |
| other | Palpitations | Cardiac disorders | Lasmiditan 100mg | 3 | 991 | 6 |
| other | Palpitations | Cardiac disorders | Lasmiditan 200mg | 5 | 1,039 | 5 |
| other | Tachycardia | Cardiac disorders | Lasmiditan 100mg | 0 | 991 | 0 |
| other | Tachycardia | Cardiac disorders | Lasmiditan 200mg | 2 | 1,039 | 3 |
1 to 10 of 724Source ClinicalTrials.gov
See all 724 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lasmiditan 100mg | 0 | 991 |
| Total, all-cause mortality | Lasmiditan 200mg | 0 | 1,039 |
| Total, other adverse events | Lasmiditan 100mg | 446 | 991 |
| Total, other adverse events | Lasmiditan 200mg | 543 | 1,039 |
| Total, serious adverse events | Lasmiditan 100mg | 29 | 991 |
| Total, serious adverse events | Lasmiditan 200mg | 36 | 1,039 |
Source ClinicalTrials.gov
Papers7
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lasmiditan 100mg vs Lasmiditan 200mg: Number of Participants With at Least 1 Treatment Emergent Adverse Event | Trial comparisons |
| Lasmiditan 100mg vs Lasmiditan 200mg: deaths from any cause | Trial comparisons |
| Lasmiditan 100mg vs Lasmiditan 200mg: serious adverse events | Trial comparisons |
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/NCT02565186
GET https://conductscience.org/api/trials/v1/NCT02565186/events?page=2