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Abstract Details

A Phase 1, Open-Label, Single-Dose Pharmacokinetic Study of Lasmiditan in Paediatric Patients with Migraine
Headache
Headache Posters (7:00 AM-5:00 PM)
042

Lasmiditan is a selective serotonin (5-HT1F) receptor agonist approved in the US for acute treatment of migraine with or without aura in adults.

This multicenter single-dose study determined lasmiditan’s pharmacokinetics, safety, and tolerability in pediatric patients aged 6 to <18 years with migraine.

Study was conducted in the US and Japan. Cohort 1 (body weight 15 to ≤40kg) and 2 (body weight >40 to ≤55kg) received 100mg and 200mg lasmiditan, respectively. This weight-based dosing was expected to elicit exposures in pediatric patients comparable to adults receiving 200mg dose. Study procedures were conducted while patients were migraine-free. Blood samples for assessment of PK and safety parameters were collected over a 24-hour (h) period. Parameters included maximum concentration (Cmax), time to maximum concentration, and area under the concentration curve (AUC).

Of 18 patients receiving lasmiditan (cohort 1:11, cohort 2:7), 17 completed the study and 1 (cohort 2) discontinued due to AEs.

Following administration, the time course of lasmiditan concentrations was similar for patients receiving 100mg/200mg. Plasma concentrations peaked at median Cmax time=1.5-2.0 h postdose and then declined with geometric mean terminal half-life=~4.0 h, similar to adult subjects. While exposure to lasmiditan expressed by Cmax and AUC was generally similar between cohorts, geometric mean values for apparent total body clearance of drug calculated after oral administration and apparent volume of distribution during terminal phase after oral administration were greater for 200-mg vs 100-mg cohort, as this reflects differences in dose and body weight in the cohorts.

No deaths or serious AEs were reported. Frequency and severity of AEs (including somnolence, dizziness, and fatigue) were similar as in adult lasmiditan studies.

PK results support weight-based dosing of lasmiditan in pediatric migraine patients. No new safety issues were identified in this study population.

Authors/Disclosures
M Tsai
PRESENTER
M Tsai has received personal compensation for serving as an employee of Eli Lilly and Company. M Tsai has received stock or an ownership interest from Eli Lilly and Company.
Emel Serap Nery (Eli Lilly and Company) Emel Serap Nery has received personal compensation for serving as an employee of Eli Lilly and Company.
Lisa Kerr (Eli Lilly and Company) Lisa Kerr has received personal compensation for serving as an employee of Eli Lilly and Company.
Rashna Khanna Rashna Khanna has nothing to disclose.
Mika Komori Mika Komori has received personal compensation for serving as an employee of Eli Lilly K.K..
Ellen Dennehy (Eli Lilly) Ellen Dennehy has received personal compensation for serving as an employee of Eli Lilly. Ellen Dennehy has stock in Eli Lilly.
Darren Wilbraham Darren Wilbraham has received personal compensation for serving as an employee of Eli Lilly and Company.