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Completed

NCT Number: NCT02439320

Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:

This is a prospective randomized, double-blind, placebo-controlled study in participants with disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Achieve Clinical Research, LLC, Birmingham, Alabama, United States

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About this study

Participants will be asked to treat a migraine attack with study drug on an outpatient basis. Participants will be provided with a dosing card containing a dose for initial treatment and a second dose to be used for rescue or recurrence of migraine. Each participant's study participation will consist of a screening visit (Visit 1) with a telephone contact within 7 days to confirm eligibility, a Treatment Period of up to 8 weeks, and an End-of-Study (EoS) visit (Visit 2) within one week (7 days) of treating a single migraine attack. The total time on study is approximately 11 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able and willing to give written informed consent.
  • 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) 2004).
  • History of disabling migraine for at least 1 year.
  • MIDAS score ≥11.
  • Migraine onset before the age of 50 years.
  • History of 3 - 8 migraine attacks per month (< 15 headache days per month).
  • Male or female, aged 18 years or above.
  • 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.

Exclusion criteria

  • Pregnant or breast-feeding women.
  • Women of child-bearing potential not using or not willing to use highly effective contraception.
  • Known coronary artery disease, clinically significant arrhythmia or uncontrolled hypertension.
  • 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 C-SSRS) or had a suicide attempt within six months prior to the screening visit.
  • Known Hepatitis B or C or 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 greater than 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.

Treatment and study plan

Lasmiditan 100 mg

Drug

Other names: LY573144

lasmiditan 200 mg

Drug

Other names: LY573144

Placebo (matches lasmiditan doses)

Drug

Primary outcomes

  1. Percentage of Participants Who Are Headache Pain Free

    Time frame: 2 hours post dose

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

  2. Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free

    Time frame: 2 hours post dose

    The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.

Secondary outcomes

  1. Percentage of Participants Who Have Headache Relief After First Dose

    Time frame: 2 hours post dose

    The percentage of participants with headache pain moderate or severe which became mild or none or with headache pain mild which became none.

  2. Percentage of Participants With Headache Recurrence

    Time frame: From 2 hours post dose up to 48 hours

    Participants who received study drug and which became pain free at 2 hours post-dose and worsened again up to 48 hours post-dose.

  3. Percentage of Participants Who Used Rescue Medication

    Time frame: 2 hours post dose

    Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).

  4. Percentage of Participants Who Used Rescue Medication

    Time frame: Anytime between 2-24 hours post dose

    Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).

  5. Percentage of Participants Who Used Rescue Medication

    Time frame: Anytime 24-48 hours post dose

    Rescue medication was permitted after completion of the 2 hour assessment if the migraine did not respond (participant was not pain free).

  6. Percentage of Participants Nausea Free

    Time frame: 2 hours post dose

    The percentage of participants without nausea.

  7. Percentage of Participants Phonophobia Free

    Time frame: 2 hours post dose

    The percentage of participants without phonophobia.

  8. Percentage of Participants Photophobia Free

    Time frame: 2 hours post dose

    The percentage of participants without photophobia.

  9. Participants With Serious Adverse Events (SAE)

    Time frame: Baseline up to 11 weeks

    Safety and Tolerability was assessed by the number of participants with at least 1 treatment emergent event (TEAE). A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section

Other outcomes

  1. Percentage of Participants With Resource Utilization

    Time frame: 6 months prior to enrolling in study to end of study (Up to 11 Weeks) within 7 days of treating a single migraine attack

    Use of health care for treatment 6 months prior to enrolling in the study and information reported during time on study

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • CoLucid Pharmaceuticals

Registry information

Official study title

A Study of Two Doses of LAsMiditan (100 mg and 200 mg) Compared to Placebo in the AcUte Treatment of MigRAIne: A Randomized, Double-blind, Placebo-controlled Parallel Group Study

Acronym: SAMURAI

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 8, 2015
Registry last updated
Dec 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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