Migraine
Conditions
Brief summary
The purpose of the study is the measure the levels of lasmiditan in the body of children aged 6 to 17 with migraine. The study also will also examine the safety and tolerability of lasmiditan in children aged 6 to 17 with migraine. The study will last about 6 weeks, and includes 4 visits.
Interventions
DRUGLasmiditan
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Participants must have a history of migraine headaches for more than 6 months * Participants must have a history of 2 to 15 migraine headaches per month in the past 2 months * Participants must weigh between 15 and 55 kilograms (kg) * Participants must not have a migraine headache on the day of lasmiditan administration
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 * Participants must not be on a medicine that acts in the brain and spinal cord
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan | 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan. |
| PK: Area Under the Concentration-Versus-Time Curve (AUC) From Time Zero to Infinity (AUC[0-∞]) of Lasmiditan | 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose | PK: Area Under the Concentration-Versus-Time Curve (AUC) from Time Zero to Infinity (AUC\[0-∞\]) of Lasmiditan. |
Countries
Japan, Puerto Rico, United States
Participant flow
Pre-assignment details
The 3-month open-label extension addendum was to evaluate safety and tolerability.
Participants by arm
| Arm | Count |
|---|---|
| 100 mg Lasmiditan Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 mg Lasmiditan. | 11 |
| 200 mg Lasmiditan Participants with higher body weight (\>40 to ≤55 kg) received single oral dose of 200 mg Lasmiditan. | 7 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Open-Label Addendum | Lost to Follow-up | 0 | 0 | 1 | 0 |
| Single-Dose Pharmacokinetic Study | Adverse Event | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | 100 mg Lasmiditan | Total | 200 mg Lasmiditan |
|---|---|---|---|
| Age, Continuous | 9.09 Years STANDARD_DEVIATION 2.02 | 11.00 Years STANDARD_DEVIATION 3.31 | 14.00 Years STANDARD_DEVIATION 2.65 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 8 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 6 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 4 Participants | 3 Participants |
| Region of Enrollment Japan | 5 Participants | 8 Participants | 3 Participants |
| Region of Enrollment United States | 6 Participants | 10 Participants | 4 Participants |
| Sex: Female, Male Female | 6 Participants | 12 Participants | 6 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 7 | 0 / 2 | 0 / 2 |
| other Total, other adverse events | 3 / 11 | 5 / 7 | 0 / 2 | 1 / 2 |
| serious Total, serious adverse events | 0 / 11 | 0 / 7 | 0 / 2 | 0 / 2 |
Outcome results
Primary
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan.
Time frame: 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose
Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 100 mg Lasmiditan | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan | 362 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 46.7 |
| 200 mg Lasmiditan | Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan | 426 nanograms per milliliter (ng/mL) | Geometric Coefficient of Variation 43.5 |
Primary
PK: Area Under the Concentration-Versus-Time Curve (AUC) From Time Zero to Infinity (AUC[0-∞]) of Lasmiditan
PK: Area Under the Concentration-Versus-Time Curve (AUC) from Time Zero to Infinity (AUC\[0-∞\]) of Lasmiditan.
Time frame: 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose
Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| 100 mg Lasmiditan | PK: Area Under the Concentration-Versus-Time Curve (AUC) From Time Zero to Infinity (AUC[0-∞]) of Lasmiditan | 2050 nanograms*hours per milliliter(ng*hr/mL) | Geometric Coefficient of Variation 38.4 |
| 200 mg Lasmiditan | PK: Area Under the Concentration-Versus-Time Curve (AUC) From Time Zero to Infinity (AUC[0-∞]) of Lasmiditan | 2590 nanograms*hours per milliliter(ng*hr/mL) | Geometric Coefficient of Variation 13.7 |