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Clinical trial

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

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Last updated:1st May 2016
Identifier: NCT02605174

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

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