Clinical trial NCT04218162: Lasmiditan Compared to Placebo in the Acute Treatment of Migraine in Korean
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Migraine
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2020-01-06
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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 ≥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.

Primary outcomes:
measure: Percentage of Participants Headache Pain Free at 2 Hours Post Dose
timeFrame: 2 hours post dose
Secondary outcomes:
measure: Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free
timeFrame: 2 hours post dose
measure: Percentage of Participants With Headache Relief
timeFrame: 2 hours post dose
measure: Number of Participants With Headache Recurrence
timeFrame: 2 Hours Post Dose Up to 48 Hours
measure: Percentage of Participants Use of Rescue Medication
timeFrame: From 2 Hours Post Dose Up to 24 Hours
measure: Number of Participants With Treatment Emergent Adverse Events
timeFrame: From Baseline Up to End of Study
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: IlDong Pharmaceutical Co Ltd
Study officials:
References: