Trial · NCT04396574
A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine
NCT04396574, Phase 3, Terminated, Eli Lilly and Company
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine. Trials, record NCT04396574. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04396574
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 12-Month Study of Lasmiditan (LY573144) Treatment in Children Aged 6 to 17 With Migraine
- NCT number
- NCT04396574
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 558 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Migraine
- Interventions
- Lasmiditan
- First posted
- 2020-05-20
- Last updated
- 2026-06-25
- Other registries' IDs
- eudract:2019-004379-38
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With at Least One Treatment Emergent Adverse Events (TEAEs) | Baseline up to 12-month treatment period (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. |
| Primary | Number of Participants With Discontinuations Due to Adverse Events (AEs) | Baseline up to 12-month treatment period (Up to 12 Months) | Participants who discontinued due to adverse events were reported in this outcome measure. |
| Secondary | Percentage of Treated Migraine Attacks With Pain Freedom (PF) at 2 Hours Post-Dose | 2 hours post-dose (for each treated migraine attack, up to 12-month treatment period) | Pain relief at 2 hours post-dose was defined as having a pain intensity of none or mild at that time point. The 5-Face Pain Scale is a single-item, self-report tool assessing pain intensity along a single domain. Participants select one face from five options to represent their current pain level; no score aggregation or calculation is performed- the selected face directly represents the pain intensity score. The five faces correspond to: Face 1= none, Face 2= mild, Faces 3-4= moderate (both faces represent moderate pain as defined by this scale, with Face 3 reflecting lower-moderate and Face 4 reflecting upper-moderate intensity) and Face 5= severe. The scale ranges from a minimum value of 1 (no pain) to a maximum value of 5 (severe pain); higher scores indicate worse outcome. Participants with a reduction in baseline pain from moderate (Faces 3 or 4) or severe (Face 5) to no pain (Face 1) at 2 hours post-dose were considered to have achieved pain freedom. |
| Secondary | Percentage of Treated Migraine Attacks With Pain Relief (PR) at 2 Hours Post-Dose | 2 hours post-dose (for each treated migraine attack, up to 12-month treatment period) | Pain relief at 2 hours post-dose was defined as having a pain intensity of none or mild at that time point. The 5-Face Pain Scale is a single-item, self-report tool assessing pain intensity along a single domain. Participants select one face from five options to represent their current pain level; no score aggregation or calculation is performed- the selected face directly represents the pain intensity score. The five faces correspond to: Face 1= none, Face 2= mild, Faces 3-4= moderate (both faces represent moderate pain as defined by this scale, with Face 3 reflecting lower-moderate and Face 4 reflecting upper-moderate intensity) and Face 5= severe. The scale ranges from a minimum value of 1 (no pain) to a maximum value of 5 (severe pain); higher scores indicate worse outcome. Participants with reduction from baseline moderate (Faces 3 or 4) or severe (Face 5) to mild or none (Face 1 or 2), or those reported as asleep at 2 hours post-dose were considered to have achieved pain relief. |
| Secondary | Percentage of Treated Migraine Attacks With Freedom From Most Bothersome Symptom (MBS) at 2 Hours After Dose | 2 hours post-dose (for each treated migraine attack, up to 12-month treatment period) | Participants identified one pre-specified most bothersome symptom (MBS) prior to each migraine dose from three options (nausea, photophobia, or phonophobia). The same pre-selected MBS was assessed at baseline (pre-dose) and at 2 hours post-dose using a binary scale recorded via electronic diary (e-Diary), where "Yes" = MBS present and "No" = MBS absent. MBS freedom was defined as a change from MBS present ("Yes") at baseline to MBS absent ("No") at 2 hours post-dose. A response of "No" at 2 hours post-dose represents a favorable outcome. Only migraine attacks in which the MBS was reported as present at baseline were included in the analysis. No aggregation, transformation, or total score calculation was performed, as this is a single-item dichotomous assessment per attack. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04396574
GET https://conductscience.org/api/trials/v1/NCT04396574/registered