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Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine (SPARTAN)

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ClinicalTrials.gov Identifier: NCT02605174
Recruitment Status : Completed
First Posted : November 16, 2015
Results First Posted : July 30, 2018
Last Update Posted : September 23, 2019
Sponsor:
Collaborator:
CoLucid Pharmaceuticals
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE November 11, 2015
First Posted Date  ICMJE November 16, 2015
Results First Submitted Date  ICMJE June 28, 2018
Results First Posted Date  ICMJE July 30, 2018
Last Update Posted Date September 23, 2019
Study Start Date  ICMJE May 2016
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2018)
  • Percentage of Participants Headache Pain Free at 2 Hours Post Dose [ 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: November 12, 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 Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 12, 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: June 28, 2018)
  • Percentage of Participants With Headache Relief [ 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.
  • Number of Participants With Headache Recurrence [ Time Frame: From 2 Hours Post Dose Up to 48 Hours ]
    The number of participants with headache recurrence (moderate or severe at baseline which became pain-free at 2 hours post dose and worsened again up to 48 hours post dose)
  • Percentage of Participants Use of Rescue Medication [ Time Frame: 2 hours post dose ]
    The percentage of participants who used rescue medication.
  • Percentage of Participants Use of Rescue Medication [ Time Frame: From 2 Hours Post Dose Up to 24 Hours ]
    The percentage of participants who used rescue medication.
  • Percentage of Participants Use of Rescue Medication [ Time Frame: From 24 Post Dose Up to 48 Hours ]
    The percentage of participants who used rescue medication.
  • Percentage of Participants Nausea Free [ Time Frame: 2 hours post dose ]
    The percentage of participant without nausea.
  • Percentage of Participants With Phonophobia Free [ Time Frame: 2 hours post dose ]
    The percentage of participants without phonophobia.
  • Percentage of Participants With Photophobia Free [ Time Frame: 2 hours post dose ]
    The percentage of participants without photophobia.
  • 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
  • Number of Participants With Treatment Emergent Events [ Time Frame: From Baseline Up to End of Study (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 Other Pre-specified Outcome Measures
 (submitted: November 12, 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 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
  • Number of participants with treatment-related adverse events [ 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 Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute Treatment of Migraine
Official Title  ICMJE A Study of Three Doses of Lasmiditan (50 mg, 100 mg and 200 mg) Compared to Placebo in the Acute TReaTment of MigrAiNe: A Randomized, Double-blind, Placebo-controlled Parallel Group Study (SPARTAN)
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 screening (Visit 1) with a telephone contact within 7 days to confirm eligibility, a Treatment Period of up to 8 weeks, and End-of-Study (EoS) (Visit 2) within one week (7 days) of treating a single migraine attack. The total time on study is approximately up to 11 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Migraine With or Without Aura
Intervention  ICMJE
  • Drug: Lasmiditan 50 mg
    One tablet lasmiditan 50 mg plus one placebo tablet (matching one of the lasmiditan doses)
    Other Name: LY573144
  • Drug: Lasmiditan 100 mg
    One tablet lasmiditan 100 mg plus one placebo tablet (matching one of the lasmiditan doses)
    Other Name: LY573144
  • Drug: Lasmiditan 200 mg
    One tablet lasmiditan 200 mg plus one placebo tablet (matching one of the lasmiditan doses)
    Other Name: LY573144
  • Drug: Placebo
    Two placebo tablets to match lasmiditan doses.
Study Arms  ICMJE
  • Experimental: Lasmiditan 50 milligram (mg)
    Oral tablet. Lasmiditan 50 mg plus placebo (to match a lasmiditan dose). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours.
    Intervention: Drug: Lasmiditan 50 mg
  • Experimental: Lasmiditan 100 mg
    Oral tablet. Lasmiditan 100 mg plus placebo (to match a lasmiditan dose). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours.
    Intervention: Drug: Lasmiditan 100 mg
  • Experimental: Lasmiditan 200 mg
    Oral tablet. Lasmiditan 200 mg plus placebo (to match a lasmiditan dose). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours.
    Intervention: Drug: Lasmiditan 200 mg
  • Placebo Comparator: Placebo
    Oral tablet. Placebo tablets match each of the lasmiditan doses (50 mg, 100 mg and 200 mg). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed between 2 and 24 hours.
    Intervention: Drug: Placebo
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: June 28, 2018)
3005
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2015)
2968
Actual Study Completion Date  ICMJE June 30, 2017
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able and willing to give written informed consent and authorize HIPAA.
  • 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.
  • 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).
  • 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 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.
  • Women of child-bearing potential not using or not willing to use highly effective contraception.
  • 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.
  • Previous participation in this clinical trial.
  • Participation in any clinical trial of an experimental drug or device in the previous 30 days.
  • 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 ≥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.
  • Participants who are employees of the sponsor.
  • Relatives of, or staff directly reporting to, the Investigator.
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 NCT02605174
Other Study ID Numbers  ICMJE 16889
H8H-CD-LAHK ( Other Identifier: Eli Lilly and Company )
2015-005689-40 ( EudraCT Number )
COL MIG-302 ( Other Identifier: Colucid )
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 September 2019

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