Migraine
Conditions
Keywords
acute, long-term, open label, safety
Brief summary
The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.
Interventions
DRUGLasmiditan
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Participants must have completed study H8H-MC-LAHX (NCT03988088) or study H8H-MC-LAHV (NCT number to be determined) * Participants must weigh at least 15 kilograms (kg)
Exclusion criteria
* Participants must not be pregnant or nursing * Participants must not have any acute, serious, or unstable medical condition * Participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Belgium, Canada, France, Germany, India, Italy, Japan, Mexico, Netherlands, Puerto Rico, Romania, Russia, Spain, United Kingdom, United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Participant flow
Recruitment details
Participants with migraine who participated in parent studies H8H MC LAHX (NCT03988088) or H8H MC LAHV (NCT04396236) were enrolled into this study H8H MC LAHW (NCT04396574) following completion of those studies, if they met eligibility criteria.
Pre-assignment details
A participant who was randomly assigned but did not treat migraine with the study drug was considered to have completed the study if the participant did not discontinue during the 12-month treatment period and attended the End of Study visit, as pre-specified in the protocol.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 13.60 years STANDARD_DEVIATION 2.68 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 208 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 84 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants |
| Race (NIH/OMB) More than one race | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 135 Participants |
| Region of Enrollment Belgium | 5 Participants |
| Region of Enrollment Canada | 1 Participants |
| Region of Enrollment France | 2 Participants |
| Region of Enrollment Germany | 0 Participants |
| Region of Enrollment India | 15 Participants |
| Region of Enrollment Italy | 16 Participants |
| Region of Enrollment Japan | 75 Participants |
| Region of Enrollment Mexico | 6 Participants |
| Region of Enrollment Netherlands | 11 Participants |
| Region of Enrollment Romania | 2 Participants |
| Region of Enrollment Russia | 7 Participants |
| Region of Enrollment Spain | 27 Participants |
| Region of Enrollment United Kingdom | 9 Participants |
| Region of Enrollment United States | 250 Participants |
| Sex: Female, Male Female | 159 Participants |
| Sex: Female, Male Male | 185 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 259 | 0 / 249 |
| other Total, other adverse events | 66 / 259 | 91 / 249 |
| serious Total, serious adverse events | 6 / 259 | 7 / 249 |
Outcome results
None listed