A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine (MONONOFU)

Lilly

Status and phase: Completed; Phase 2

Conditions: Migraine

Treatments: Drug: Lasmiditan; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03962738

H8H-JE-LAIH (Other Identifier)

17012

Details and patient eligibility

About

This study will assess the efficacy and safety of lasmiditan in the acute treatment of a migraine attack in Japanese adult participants with or without aura.

Enrollment: 846 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with migraine with or without aura fulfilling the International Classification of Headache Disorders (ICHD)-2.
• History of disabling migraine for at least 1 year.
• Migraine Disability Assessment Test (MIDAS) score ≥11.
• Migraine onset before the age of 50 years.
• History of 3-8 migraine attacks per month and <15 headache days per month during the past 3 months.

Exclusion criteria

• Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets.
• History or evidence of hemorrhagic stroke, epilepsy, or any other condition placing the patient at increased risk of seizures.
• History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo, Meniere's disease, vestibular migraine, and other vestibular disorders.
• History of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy).
• History of orthostatic hypotension with syncope.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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846 participants in 4 patient groups, including a placebo group

50 milligram (mg) Lasmiditan

Experimental group

Description:

50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.

Treatment:

Drug: Placebo

Drug: Lasmiditan

100 mg Lasmiditan

Experimental group

Description:

100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.

Treatment:

Drug: Placebo

Drug: Lasmiditan

200 mg Lasmiditan

Experimental group

Description:

200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.

Treatment:

Drug: Placebo

Drug: Lasmiditan

Placebo

Placebo Comparator group

Description:

Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.

Treatment:

Drug: Placebo