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Clinical trial

Lasmiditan Compared to Placebo in the Acute Treatment of Migraine: (SAMURAI)

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Last updated:1st Apr 2015
Identifier: NCT02439320

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

Detailed Description:
Subjects will be asked to treat a migraine attack with study drug on an outpatient basis. Subjects 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 subject'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.

Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 2232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date: April 2015
Actual Primary Completion Date: July 2016
Actual Study Completion Date: August 2016

- Experimental:
Lasmiditan 100 mg
- Experimental: Lasmiditan 200 mg
- Placebo Comparator: Placebo

Category Value
Date last updated at source 2018-04-05
Study type(s) Interventional
Expected enrolment 2232
Study start date 2015-04-01
Estimated primary completion date 2016-07-01

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