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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 : July 30, 2018
Sponsor:
Collaborator:
CoLucid Pharmaceuticals
Information provided by (Responsible Party):
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Migraine With or Without Aura Drug: Lasmiditan 50 mg Drug: Lasmiditan 100 mg Drug: Lasmiditan 200 mg Drug: Placebo Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 3005 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : May 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
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.
Drug: Lasmiditan 50 mg
One tablet lasmiditan 50 mg plus one placebo tablet (matching one of the lasmiditan doses)
Other Name: LY573144

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.
Drug: Lasmiditan 100 mg
One tablet lasmiditan 100 mg plus one placebo tablet (matching one of the lasmiditan doses)
Other Name: LY573144

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.
Drug: Lasmiditan 200 mg
One tablet lasmiditan 200 mg plus one placebo tablet (matching one of the lasmiditan doses)
Other Name: LY573144

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.
Drug: Placebo
Two placebo tablets to match lasmiditan doses.




Primary Outcome Measures :
  1. 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.

  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.


Other Outcome Measures:
  1. 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.

  2. 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)

  3. Percentage of Participants Use of Rescue Medication [ Time Frame: 2 hours post dose ]
    The percentage of participants who used rescue medication.

  4. 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.

  5. 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.

  6. Percentage of Participants Nausea Free [ Time Frame: 2 hours post dose ]
    The percentage of participant without nausea.

  7. Percentage of Participants With Phonophobia Free [ Time Frame: 2 hours post dose ]
    The percentage of participants without phonophobia.

  8. Percentage of Participants With Photophobia Free [ Time Frame: 2 hours post dose ]
    The percentage of participants without photophobia.

  9. 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

  10. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02605174


  Show 95 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
CoLucid Pharmaceuticals
Investigators
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
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] November 30, 2015
Statistical Analysis Plan  [PDF] July 18, 2017


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02605174     History of Changes
Other Study ID Numbers: 16889
H8H-CD-LAHK ( Other Identifier: Eli Lilly and Company )
2015-005689-40 ( EudraCT Number )
COL MIG-302 ( Other Identifier: Colucid )
First Posted: November 16, 2015    Key Record Dates
Results First Posted: July 30, 2018
Last Update Posted: July 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Lilly provides access to the individual participant data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases