Trial Outcomes & Findings for A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With Migraine (NCT NCT03988088)
NCT ID: NCT03988088
Last Updated: 2020-09-01
Results Overview
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdose
Results posted on
2020-09-01
Participant Flow
The 3-month open-label extension addendum was to evaluate safety and tolerability.
Participant milestones
| Measure |
100 Milligrams (mg) Lasmiditan
Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 mg Lasmiditan.
|
200 mg Lasmiditan
Participants with higher body weight (\>40 to ≤55 kg) received single oral dose of 200 mg Lasmiditan.
|
50 mg Lasmiditan-Addendum
Participants with lower body weight (15 to ≤40 kg) received single oral dose of 50 mg Lasmiditan.
|
100 mg Lasmiditan-Addendum
Participants with higher body weight (\>40 to ≤55 kg) received single oral dose of 100 mg Lasmiditan.
|
|---|---|---|---|---|
|
Single-Dose Pharmacokinetic Study
STARTED
|
11
|
7
|
0
|
0
|
|
Single-Dose Pharmacokinetic Study
COMPLETED
|
11
|
6
|
0
|
0
|
|
Single-Dose Pharmacokinetic Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Open-Label Addendum
STARTED
|
0
|
0
|
2
|
2
|
|
Open-Label Addendum
COMPLETED
|
0
|
0
|
1
|
2
|
|
Open-Label Addendum
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
100 Milligrams (mg) Lasmiditan
Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 mg Lasmiditan.
|
200 mg Lasmiditan
Participants with higher body weight (\>40 to ≤55 kg) received single oral dose of 200 mg Lasmiditan.
|
50 mg Lasmiditan-Addendum
Participants with lower body weight (15 to ≤40 kg) received single oral dose of 50 mg Lasmiditan.
|
100 mg Lasmiditan-Addendum
Participants with higher body weight (\>40 to ≤55 kg) received single oral dose of 100 mg Lasmiditan.
|
|---|---|---|---|---|
|
Single-Dose Pharmacokinetic Study
Adverse Event
|
0
|
1
|
0
|
0
|
|
Open-Label Addendum
Lost to Follow-up
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of Lasmiditan (LY573144) in Children Aged 6 to 17 With Migraine
Baseline characteristics by cohort
| Measure |
100 mg Lasmiditan
n=11 Participants
Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 mg Lasmiditan.
|
200 mg Lasmiditan
n=7 Participants
Participants with higher body weight (\>40 to ≤55 kg) received single oral dose of 200 mg Lasmiditan.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.09 Years
STANDARD_DEVIATION 2.02 • n=5 Participants
|
14.00 Years
STANDARD_DEVIATION 2.65 • n=7 Participants
|
11.00 Years
STANDARD_DEVIATION 3.31 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan.
Outcome measures
| Measure |
100 mg Lasmiditan
n=11 Participants
Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 mg Lasmiditan.
|
200 mg Lasmiditan
n=7 Participants
Participants with higher body weight (\>40 to ≤55 kg) received single oral dose of 200 mg Lasmiditan.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Lasmiditan
|
362 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 46.7
|
426 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 43.5
|
PRIMARY outcome
Timeframe: 0.5, 1, 1.5, 2, 3, 4, 8, 12 and 24 hours postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: Area Under the Concentration-Versus-Time Curve (AUC) from Time Zero to Infinity (AUC\[0-∞\]) of Lasmiditan.
Outcome measures
| Measure |
100 mg Lasmiditan
n=11 Participants
Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 mg Lasmiditan.
|
200 mg Lasmiditan
n=6 Participants
Participants with higher body weight (\>40 to ≤55 kg) received single oral dose of 200 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
|
2590 nanograms*hours per milliliter(ng*hr/mL)
Geometric Coefficient of Variation 13.7
|
Adverse Events
100 mg Lasmiditan
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
200 mg Lasmiditan
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
50 mg Lasmiditan-Addendum
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
100 mg Lasmiditan-Addendum
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
100 mg Lasmiditan
n=11 participants at risk
Participants with lower body weight (15 to ≤40 kilograms (kg)) received single oral dose of 100 mg Lasmiditan.
|
200 mg Lasmiditan
n=7 participants at risk
Participants with higher body weight (\>40 to ≤55 kg) received single oral dose of 200 mg Lasmiditan.
|
50 mg Lasmiditan-Addendum
n=2 participants at risk
Participants with lower body weight (15 to ≤40 kg) received single oral dose of 50 mg Lasmiditan.
|
100 mg Lasmiditan-Addendum
n=2 participants at risk
Participants with higher body weight (\>40 to ≤55 kg) received single oral dose of 100 mg Lasmiditan.
|
|---|---|---|---|---|
|
Eye disorders
Lacrimation increased
|
0.00%
0/11 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/11 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/11 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
42.9%
3/7 • Number of events 4 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
50.0%
1/2 • Number of events 2 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/11 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 2 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/11 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Number of events 1 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
57.1%
4/7 • Number of events 5 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
18.2%
2/11 • Number of events 2 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/11 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/11 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/2 • Up To 3.5 Months
All randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER