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Trial record 1 of 2 for:    02439320
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Lasmiditan Compared to Placebo in the Acute Treatment of Migraine: (SAMURAI)

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ClinicalTrials.gov Identifier: NCT02439320
Recruitment Status : Completed
First Posted : May 8, 2015
Results First Posted : November 27, 2019
Last Update Posted : December 16, 2019
Sponsor:
Collaborator:
CoLucid Pharmaceuticals
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE March 18, 2015
First Posted Date  ICMJE May 8, 2015
Results First Submitted Date  ICMJE November 8, 2019
Results First Posted Date  ICMJE November 27, 2019
Last Update Posted Date December 16, 2019
Study Start Date  ICMJE April 2015
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 6, 2015)
Proportion of subjects headache pain free at 2 hours post dose [ Time Frame: 2 hours post dose ]
Defined as moderate or severe headache pain becoming none
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2019)
  • 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.
  • 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.
  • 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).
  • 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).
  • 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).
  • Percentage of Participants Nausea Free [ Time Frame: 2 hours post dose ]
    The percentage of participants without nausea.
  • Percentage of Participants Phonophobia Free [ Time Frame: 2 hours post dose ]
    The percentage of participants without phonophobia.
  • Percentage of Participants Photophobia Free [ Time Frame: 2 hours post dose ]
    The percentage of participants without photophobia.
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2015)
Proportion of subjects who are most bothersome associated symptom (MBS) free at 2 hours post dose [ Time Frame: 2 hours post dose ]
Defined as the associated symptom present and identified as MBS prior to dosing being absent at 2 hours.
Current Other Pre-specified Outcome Measures
 (submitted: November 8, 2019)
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
Original Other Pre-specified Outcome Measures
 (submitted: May 6, 2015)
  • Headache relief [ Time Frame: 2 hours post dose ]
    A reduction in headache pain from moderate or severe to mild or none
  • Use of rescue medication [ Time Frame: 2 hours post dose, 2-24 hours post dose and 48 hours ]
  • Headache recurrence [ Time Frame: From 2 hours post dose up to 48 hours ]
    The proportion of subjects with headache recurrence (moderate or severe headache at baseline, which became pain free at 2 hours post-dose and worsened again up to 48 hours post-dose)
  • Proportion of patients nausea free, phonophobia free or photophobia free [ Time Frame: 2 hours post dose ]
    Defined as the specified associated symptom being absent at 2 hours post-dose
  • Safety [ Time Frame: up to 11 weeks ]
    Adverse events
  • Resource utilization [ Time Frame: 6 months prior to enrolling in study to End of Study visit (within 7 days of treating a single migraine attack) ]
    Use of health care for treatment 6 months prior to enrolling in the study compared to information reported during time on study.
 
Descriptive Information
Brief Title  ICMJE Lasmiditan Compared to Placebo in the Acute Treatment of Migraine:
Official Title  ICMJE 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
Brief Summary This is a prospective randomized, double-blind, placebo-controlled study in participants with disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acute Migraine
Intervention  ICMJE
  • Drug: Lasmiditan 100 mg
    Other Name: LY573144
  • Drug: Lasmiditan 200 mg
    Other Name: LY573144
  • Drug: Placebo (matches lasmiditan doses)
Study Arms  ICMJE
  • Experimental: Lasmiditan 100 mg
    Oral tablet. Lasmiditan 100 mg plus placebo (to match 200 mg tablet). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.
    Interventions:
    • Drug: Lasmiditan 100 mg
    • Drug: Placebo (matches lasmiditan doses)
  • Experimental: Lasmiditan 200 mg
    Oral tablet. Lasmiditan 200 mg plus placebo (to match 100 mg tablet). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.
    Interventions:
    • Drug: Lasmiditan 200 mg
    • Drug: Placebo (matches lasmiditan doses)
  • Placebo Comparator: Placebo
    Oral tablet. Placebo tablets match lasmiditan 100 mg and lasmiditan 200 mg. One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.
    Intervention: Drug: Placebo (matches lasmiditan doses)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2019)
2231
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2015)
2225
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02439320
Other Study ID Numbers  ICMJE 16888
H8H-CD-LAHJ ( Other Identifier: Eli Lilly and Company )
COL MIG-301 ( Other Identifier: CoLucid Pharmaceuticals )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE CoLucid Pharmaceuticals
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP