Lasmiditan Compared to Placebo in the Acute Treatment of Migraine in Korean

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

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

Study Overview

• Status: Completed
• Conditions: Acute Migraine
• Intervention / Treatment: Drug: Placebo; Drug: Lasmiditan 50mg; Drug: Lasmiditan 100mg

• Study Type: Interventional
• Enrollment (Actual): 294
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • IlDong Pharmaceutical Co Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 ≥11.
• 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.
• Participation in any clinical trial of an experimental drug or device in the previous 30 days.
• Known Hepatitis B or C or human immunodeficiency virus(HIV) infection. History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (e.g. hemicranias continua, medication overuse headache) where headache frequency is ≥15 headache days per month.
• Use of more than 3 doses per month of either opiates or barbiturates.
• Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within three (3) months prior to Screening/Visit 1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Experimental: Lasmiditan 50mg	Drug: Lasmiditan 50mg; Lasmiditan 50mg
Experimental: Lasmiditan 100mg	Drug: Lasmiditan 100mg; Lasmiditan 100mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Headache Pain Free at 2 Hours Post Dose	The percentage of participants defined as mild, moderate, or severe headache pain becoming none.	2 hours post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free	The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.	2 hours post dose
Percentage of Participants With Headache Relief	The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.	2 hours post dose
Percentage of Participants Use of Rescue Medication	The percentage of participants who used rescue medication.	From 2 Hours Post Dose Up to 24 Hours
Number of Participants With Headache Recurrence	The number of participants with headache recurrence	2 Hours Post Dose Up to 48 Hours
Number of Participants With Treatment Emergent Adverse Events	Safety and tolerability was assessed by the number of participants with at least 1 treatment adverse emergent event.	From Baseline Up to End of Study

Collaborators and Investigators

• Sponsor: IlDong Pharmaceutical Co Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2020
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: January 2, 2020
• First Submitted That Met QC Criteria: January 2, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 31, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; Lasmiditan
• Other Study ID Numbers: ID-LAS-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No