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

Recruiting in Palo Alto (17 mi)

+94 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

Inclusion Criteria

Able and willing to give written informed consent and authorize HIPAA.

Participants with migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1 (International Headache Classification (ICHD) 2004).

History of disabling migraine for at least 1 year.

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Treatment Details

Interventions

Lasmiditan (Serotonin (5-HT) 1F Receptor Agonist)
Placebo (Drug)

Participant Groups

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Lasmiditan 50 milligram (mg)Experimental Treatment1 Intervention

Oral tablet. Lasmiditan 50 mg plus placebo (to match a lasmiditan dose). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours.

Group II: Lasmiditan 200 mgExperimental Treatment1 Intervention

Oral tablet. Lasmiditan 200 mg plus placebo (to match a lasmiditan dose). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours.

Group III: Lasmiditan 100 mgExperimental Treatment1 Intervention

Oral tablet. Lasmiditan 100 mg plus placebo (to match a lasmiditan dose). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours.

Group IV: PlaceboPlacebo Group1 Intervention

Oral tablet. Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours.

Lasmiditan is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Reyvow for: