NCT02439320

Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:

A Study of Two Doses of LAsMiditan (100 mg and 200 mg) Compared to Placebo in the AcUte Treatment of MigRAIne: A Randomized, Double-blind, Placebo-controlled Parallel Group Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,231 (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 a screening visit (Visit 1) with a telephone contact within 7 days to confirm eligibility, a Treatment Period of up to 8 weeks, and an End-of-Study (EoS) visit (Visit 2) within one week (7 days) of treating a single migraine attack. The total time on study is approximately 11 weeks.

Conditions

• Acute Migraine

Interventions

Type	Name	Description
DRUG	Lasmiditan 100 mg
DRUG	Lasmiditan 200 mg
DRUG	Placebo (matches lasmiditan doses)

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-07-01
• Completion: 2016-08-01
• First posted: 2015-05-08
• Last updated: 2019-12-16
• Results posted: 2019-11-27

Locations

92 sites across 1 country: United States