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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 : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE September 12, 2018
First Posted Date  ICMJE September 14, 2018
Last Update Posted Date April 17, 2019
Estimated Study Start Date  ICMJE June 20, 2019
Estimated Primary Completion Date March 26, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2018)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03670810 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2018)
  • 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
  • Percentage of Participants with Pain Relief at 2 Hours Post Dose during the First Attack [ Time Frame: 2 Hours Postdose ]
    Percentage of participants with pain relief at 2 hours post dose during the first attack
  • 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
  • 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
  • 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
  • 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
  • Percentage of Participants with Pain Freedom, Pain Relief, Freedom from MBS, and No Disability Postdose During First Attack [ Time Frame: 2 Hours Postdose ]
    Percentage of participants with pain freedom, pain relief, freedom from MBS, and no disability postdose during first attack
  • 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
  • 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
  • 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
  • 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
  • Percentage of Participants Satisfied with their Treatment Measured by a 4-Item Questionnaire [ Time Frame: Week 16 ]
    Percentage of participants satisfied with their treatment measured by a 4-item questionnaire
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2018)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Lasmiditan (LY573144) Over Four Migraine Attacks
Official Title  ICMJE Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE
  • Drug: Lasmiditan
    Administered orally.
    Other Name: LY573144
  • Drug: Placebo
    Administered orally.
Study Arms  ICMJE
  • Experimental: Lasmiditan High Dose
    Lasmiditan administered orally. Placebo administered orally to maintain blind.
    Interventions:
    • Drug: Lasmiditan
    • Drug: Placebo
  • Experimental: Lasmiditan Low Dose
    Lasmiditan administered orally. Placebo administered orally to maintain blind.
    Interventions:
    • Drug: Lasmiditan
    • Drug: Placebo
  • Placebo Comparator: Control
    Placebo and lasmiditan administered orally.
    Interventions:
    • Drug: Lasmiditan
    • Drug: Placebo
Publications * Not Provided

*   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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 12, 2018)
1600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 29, 2021
Estimated Primary Completion Date March 26, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1
  • 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
  • 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
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: 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
Listed Location Countries  ICMJE Austria,   Belgium,   China,   Czechia,   Denmark,   France,   Germany,   Hungary,   India,   Italy,   Mexico,   Netherlands,   Russian Federation,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03670810
Other Study ID Numbers  ICMJE 17131
H8H-MC-LAIJ ( Other Identifier: Eli Lilly and Company )
2018-001661-17 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.

Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
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 April 15, 2019

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