Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine (SPARTAN)
Brief 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.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 3005 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date: May 2016
Actual Primary Completion Date: June 30, 2017
Actual Study Completion Date: June 30, 2017
Arms:
- Experimental: Lasmiditan 50 mg
- Experimental: Lasmiditan 100 mg
- Experimental: Lasmiditan 200 mg
- Placebo Comparator: Placebo
Category | Value |
---|---|
Date last updated at source | 2019-09-23 |
Study type(s) | Interventional |
Expected enrolment | 3005 |
Study start date | 2016-05-01 |
Estimated primary completion date | 2017-06-30 |