This site is intended for healthcare professionals
Clinical trials
  • Home
  • /
  • Clinical trials
  • /
  • Uncategorised Disease
  • /
  • Three Doses of Lasmiditan (50 mg, 100 mg and 200 m...
Clinical trial

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

Read time: 3 mins
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

- 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

View full details