A Randomized, Double-blind, Placebo-controlled Parallel Group Study to Evaluate Efficacy and Safety of Lasmiditan Compared to Placebo in the Acute Treatment of Migraine

IlDong Pharmaceutical Co Ltd1 site in 1 country294 target enrollmentMarch 24, 2020

ConditionsAcute Migraine

InterventionsLasmiditan 50mg Lasmiditan 100mg Placebo

DrugsLasmiditan 50mg Lasmiditan 100mg Placebo

Overview

Phase: Phase 3
Intervention: Lasmiditan 50mg
Conditions: Acute Migraine
Sponsor: IlDong Pharmaceutical Co Ltd
Enrollment: 294
Locations: 1
Primary Endpoint: Percentage of Participants Headache Pain Free at 2 Hours Post Dose
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A randomized, double-blind, placebo-controlled parallel group study to evaluate efficacy and safety of lasmiditan tablet compared to Placebo in the acute treatment of Migraine

Registry

clinicaltrials.gov

Start Date

March 24, 2020

End Date

October 30, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

IlDong Pharmaceutical Co Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Able and willing to give written informed consent.
•Male or female, aged 18 years or above.
•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-3).
•History of disabling migraine for at least 1 year.
•Migraine Disability Association (MIDAS) score ≥
•Migraine onset before the age of 50 years.
•History of 3 - 8 migraine attacks per month (\< 15 headache days per month).
•Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD), abstinence or vasectomized partner).
•Able and willing to complete an electronic diary to record details of the migraine attack treated with study drug.

Exclusion Criteria

•Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the participant unsuitable for the study.
•Pregnant or breast-feeding women.
•Known hypersensitivity to lasmiditan or to any excipient of lasmiditan oral tablets, or any sensitivity to lasmiditan.
•History or evidence of hemorrhagic stroke, epilepsy or any other condition placing the participant at increased risk of seizures.
•History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo (BPPV), Meniere's disease, vestibular migraine, and other vestibular disorders.
•History of diabetes mellitus with complications (diabetic retinopathy, nephropathy or neuropathy).
•History within the previous three years or current evidence of abuse of any drug, prescription or illicit, or alcohol.
•History of orthostatic hypotension with syncope.
•Significant renal or hepatic impairment.
•Participant is at imminent risk of suicide (positive response to question 4 or 5) on the Columbia-Suicide Severity Rating Scale (C-SSRS) or had a suicide attempt within six months prior to screening.

Arms & Interventions

Lasmiditan 50mg

Intervention: Lasmiditan 50mg

Lasmiditan 100mg

Intervention: Lasmiditan 100mg

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Percentage of Participants Headache Pain Free at 2 Hours Post Dose

Time Frame: 2 hours post dose

The percentage of participants defined as mild, moderate, or severe headache pain becoming none.

Secondary Outcomes

Number of Participants With Treatment Emergent Adverse Events(From Baseline Up to End of Study)
Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free(2 hours post dose)
Percentage of Participants With Headache Relief(2 hours post dose)
Number of Participants With Headache Recurrence(2 Hours Post Dose Up to 48 Hours)
Percentage of Participants Use of Rescue Medication(From 2 Hours Post Dose Up to 24 Hours)