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

NCT04218162 | Completed Phase 3

• 1 other identifier: ID-LAS-301
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Migraine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• Number of Participants With Treatment Emergent Adverse Events

  From Baseline Up to End of Study

Study Arms (3)

Lasmiditan 50mg

EXPERIMENTAL

Drug: Lasmiditan 50mg

Lasmiditan 100mg

EXPERIMENTAL

Drug: Lasmiditan 100mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lasmiditan 50mg DRUG

Lasmiditan 50mg

Lasmiditan 50mg

Lasmiditan 100mg DRUG

Lasmiditan 100mg

Lasmiditan 100mg

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead

Study Sites (1)

IlDong Pharmaceutical Co Ltd

Seoul, South Korea

Location

MeSH Terms

Interventions

lasmiditan

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 6, 2020
• Study Start: March 24, 2020
• Primary Completion: October 30, 2020
• Study Completion: October 30, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

KR (1)