NCT02605174

Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine

A Study of Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute TReaTment of MigrAiNe: A Randomized, Double-blind, Placebo-controlled Parallel Group Study (SPARTAN)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,005 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective randomized, double-blind, placebo-controlled study in participants with disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).

Detailed description

Participants will be asked to treat a migraine attack with study drug on an outpatient basis. Participants will be provided with a dosing card containing a dose for initial treatment and a second dose to be used for rescue or recurrence of migraine. Each participant's study participation will consist of screening (Visit 1) with a telephone contact within 7 days to confirm eligibility, a Treatment Period of up to 8 weeks, and End-of-Study (EoS) (Visit 2) within one week (7 days) of treating a single migraine attack. The total time on study is approximately up to 11 weeks.

Conditions

• Migraine With or Without Aura

Interventions

Type	Name	Description
DRUG	Lasmiditan 50 mg	One tablet lasmiditan 50 mg plus one placebo tablet (matching one of the lasmiditan doses)
DRUG	Lasmiditan 100 mg	One tablet lasmiditan 100 mg plus one placebo tablet (matching one of the lasmiditan doses)
DRUG	Lasmiditan 200 mg	One tablet lasmiditan 200 mg plus one placebo tablet (matching one of the lasmiditan doses)
DRUG	Placebo	Two placebo tablets to match lasmiditan doses.

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-06-30
• Completion: 2017-06-30
• First posted: 2015-11-16
• Last updated: 2019-09-23
• Results posted: 2018-07-30

Locations

95 sites across 1 country: United States