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A Study of Lasmiditan (LY573144) Over Four Migraine Attacks

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ClinicalTrials.gov Identifier: NCT03670810
Recruitment Status : Not yet recruiting
First Posted : September 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The reason for this study is to see how effective and safe the study drug known as lasmiditan is in the acute treatment of 4 migraine attacks with or without aura.

Condition or disease Intervention/treatment Phase
Migraine Drug: Lasmiditan Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks
Estimated Study Start Date : November 20, 2018
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : June 11, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Lasmiditan High Dose
Lasmiditan administered orally. Placebo administered orally to maintain blind.
Drug: Lasmiditan
Administered orally.
Other Name: LY573144

Drug: Placebo
Administered orally.

Experimental: Lasmiditan Low Dose
Lasmiditan administered orally. Placebo administered orally to maintain blind.
Drug: Lasmiditan
Administered orally.
Other Name: LY573144

Drug: Placebo
Administered orally.

Placebo Comparator: Control
Placebo and lasmiditan administered orally.
Drug: Lasmiditan
Administered orally.
Other Name: LY573144

Drug: Placebo
Administered orally.




Primary Outcome Measures :
  1. Percentage of Participants that are Pain Free 2 Hours Postdose during the First Attack [ Time Frame: 2 Hours Postdose ]
    Percentage of participants that are pain free 2 hours postdose during the first attack

  2. Percentage of Participants that are Pain Free at 2 Hours Postdose in at Least 2 out of 3 Attacks [ Time Frame: 2 Hours Postdose ]
    Percentage of participants that are pain free at 2 hours postdose in at least 2 out of 3 attacks


Secondary Outcome Measures :
  1. Percentage of Participants Very Much or Much Better as Measured by Patient Global Impression of Change (PGI-C), at 2 Hours Postdose During the First Attack [ Time Frame: 2 Hours Postdose ]
    Percentage of participants very much or much better as measured by PGI-C, at 2 hours postdose during the first attack

  2. Migraine Quality of Life Questionnaire (MQoLQ) Score at 24 Hours Post First Dose of Study During First Attack [ Time Frame: 24 Hours Post First Dose ]
    MQoLQ score at 24 hours post first dose of study during first attack

  3. Percentage of Participants Free of Most Bothersome Symptom (MBS) Associated with Migraine at 2 Hours Postdose During the First Attack [ Time Frame: 2 Hours Postdose ]
    Percentage of participants that are free of MBS associated with migraine at 2 hours postdose during the first attack

  4. Percentage of Participants with Pain Relief at 2 Hours Post First Dose during the First Attack [ Time Frame: 2 Hours Postdose ]
    Percentage of participants with pain relief at 2 hours post first dose during the first attack

  5. Percentage of Participants with 24-Hour Sustained Pain Freedom during the First Attack [ Time Frame: 24 Hours ]
    Percentage of participants with 24-hour sustained pain freedom during the first attack

  6. Percentage of Participants Requiring Rescue Medication for Migraine within 24 Hours of Treatment during the First Attack [ Time Frame: 24 Hours ]
    Percentage of participants requiring rescue medication for migraine within 24 hours of treatment during the first attack

  7. Percentage of Participants that are Free of Symptoms Associated with Migraine at 2 Hours Postdose During the First Attack [ Time Frame: 2 Hours Postdose ]
    Percentage of participants that are free of symptoms associated with migraine at 2 hours postdose during the first attack

  8. Percentage of Participants with Migraine Recurrence at 24 Hours during the First Attack [ Time Frame: 24 Hours ]
    Percentage of participants with migraine recurrence at 24 hours during the first attack defined as return of any headache in patients who were pain free at 2 hours

  9. Percentage of Participants with Pain Freedom, Pain Relief, Freedom from MBS, and No Disability after Taking the First Dose of Study Drug During First Attack [ Time Frame: 2 Hours Postdose ]
    Percentage of participants with pain freedom, pain relief, freedom from MBS, and no disability after taking the first dose of study drug during first attack

  10. Change from Baseline in Total Score as Measured by the Migraine Disability Assessment Test (MIDAS) Scale [ Time Frame: Baseline, Week 16 ]
    Change from baseline in total score as measured by the MIDAS scale

  11. Percentage of Participants with no Disability as Measured by the Disability Item, at 2 Hours Postdose during the First Attack [ Time Frame: 2 Hours Postdose ]
    Percentage of participants with no disability as measured by the disability item, at 2 hours postdose during the first attack

  12. Change from Baseline in Utility as Measured by the EuroQol 5-Dimension 5-Level Scale (EQ-5D-5L) at 24 Hours Postdose During First Attack [ Time Frame: Baseline, 24 Hours Postdose ]
    Change from baseline in utility as measured by the EQ-5D-5L at 24 hours postdose during first attack

  13. Percentage of Participants with Pain Relief at 2 Hours Postdose in at Least 2 out of 3 Attacks [ Time Frame: 2 Hours Postdose ]
    Percentage of participants with pain relief at 2 hours postdose in at least 2 out of 3 attacks

  14. Percentage of Participants that are Pain Free at 2 Hours Postdose in at Least 3 out of 4 Attacks [ Time Frame: 2 Hours Postdose ]
    Percentage of participants that are pain free (defined as mild, moderate, or severe headache pain becoming none) at 2 hours postdose in at least 3 out of 4 attacks

  15. Percentage of Participants with Pain Relief at 2 Hours Postdose in at Least 3 out of 4 Attacks [ Time Frame: 2 Hours Postdose ]
    Percentage of participants with pain relief at 2 hours postdose in at least 3 out of 4 attacks



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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:

  • Migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2
  • History of disabling migraine for at least 1 year
  • Migraine onset before the age of 50 years
  • History of 3 to 8 migraine attacks per month (<15 headache days per month) during the past 3 months
  • MIDAS score ≥11
  • Able and willing to complete an eDiary to record the details of each migraine attack treated with study drug
  • Women of child-bearing potential must be using or willing to use a highly effective form of contraception
  • Agree not to post any personal medical data or information related to the study on any website or social media site until the entire trial has completed

Exclusion Criteria:

  • Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets
  • 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, Meniere's disease, vestibular migraine, and other vestibular disorders
  • History of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy)
  • History of orthostatic hypotension with syncope
  • Significant renal or hepatic impairment in the opinion of the investigator or if they meet hepatic monitoring criteria
  • Participants who, in the investigator's judgment, are actively suicidal and therefore deemed to be at significant risk for suicide
  • 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 (eg, hemicranias continua, medication overuse headache where headache frequency is ≥15 headache days per month)
  • Use of more than 3 doses per month of either opioids or barbiturates
  • Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within 3 months prior to screening
  • Pregnant or breast-feeding women
  • History of drug or alcohol abuse/dependence within 1 year prior to screening
  • Any medical condition or clinical laboratory test which in the judgment of the investigator makes the participant unsuitable for the study
  • Currently enrolled in any other clinical study involving an investigational product
  • Relatives of, or staff directly reporting to, the Investigator
  • Participants who are employees of the sponsor

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): NCT03670810


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

Sponsors and Collaborators
Eli Lilly and Company
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03670810     History of Changes
Other Study ID Numbers: 17131
H8H-MC-LAIJ ( Other Identifier: Eli Lilly and Company )
2018-001661-17 ( EudraCT Number )
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient 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.


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eli Lilly and Company:
acute treatment
migraine pain
multiple attacks
headache

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