Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study Lasmiditan (LY573144) in a Single Migraine Attack in Japanese Participants With Migraine (MONONOFU)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03962738
Recruitment Status : Recruiting
First Posted : May 24, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This study will assess the efficacy and safety of lasmiditan in the acute treatment of a migraine attack in Japanese adult participants with or without aura.

Condition or disease Intervention/treatment Phase
Migraine Drug: Lasmiditan Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 880 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: RandoMized, DOuble-bliNd, PlacebO-coNtrolled Trial Of Lasmiditan in a Single Migraine Attack in Japanese Patients SuFfering From Migraine With or WithoUt Aura - the MONONOFU Study
Actual Study Start Date : May 31, 2019
Estimated Primary Completion Date : March 18, 2020
Estimated Study Completion Date : March 18, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Experimental: Lasmiditan Low Dose
Lasmiditan given orally and placebo given orally to maintain the blind.
Drug: Lasmiditan
Administered orally
Other Name: LY573144

Drug: Placebo
Administered orally

Experimental: Lasmiditan Mid Dose
Lasmiditan given orally and placebo given orally to maintain the blind.
Drug: Lasmiditan
Administered orally
Other Name: LY573144

Drug: Placebo
Administered orally

Experimental: Lasmiditan High Dose
Lasmiditan given orally and placebo given orally to maintain the blind.
Drug: Lasmiditan
Administered orally
Other Name: LY573144

Drug: Placebo
Administered orally

Placebo Comparator: Placebo
Placebo given orally.
Drug: Placebo
Administered orally




Primary Outcome Measures :
  1. Percentage of Participants who are Pain Free (High Dose) [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants who are Pain Free (High Dose)


Secondary Outcome Measures :
  1. Percentage of Participants who are Pain Free in Each Dose Group [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants who are Pain Free in Each Dose Group

  2. Percentage of Participants with Pain Relief [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants with Pain Relief

  3. Percentage of Participants who are Free of MBS Associated with Migraine [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants who are Free of the Most Bothersome Symptom as Identified by the Individual from the Associated Symptoms of Nausea, Phonophobia or Photophobia (MBS) Associated with Migraine

  4. Percentage of Participants with 24-Hour Sustained Pain Freedom [ Time Frame: 24 Hours ]
    Sustained pain freedom defined as pain free at 2 and 24 hours with no rescue medication.

  5. Percentage of Participants with 48-Hour Sustained Pain Freedom [ Time Frame: 48 Hours ]
    Sustained pain freedom defined as pain free at 2 and 48 hours with no rescue medication.

  6. Percentage of Participants that are Free of Phonophobia [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants that are Free of Phonophobia

  7. Percentage of Participants that are Free of Photophobia [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants that are Free of Photophobia

  8. Percentage of Participants that are Free of Nausea [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants that are Free of Nausea

  9. Percentage of Participants that are Free of Vomiting [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants that are Free of Vomiting

  10. Percentage of Participants with Pain Freedom [ Time Frame: 1 Hour Postdose ]
    Percentage of Participants with Pain Freedom

  11. Percentage of Participants with Pain Relief [ Time Frame: 1 Hour Postdose ]
    Percentage of Participants with Pain Relief

  12. Percentage of Participants with Freedom from MBS [ Time Frame: 1 Hour Postdose ]
    Percentage of Participants with Freedom from MBS

  13. Percentage of Participants with No Disability [ Time Frame: 1 Hour Postdose ]
    Percentage of Participants with No Disability

  14. Percentage of Participants with No Disability [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants with No Disability

  15. Change from Baseline on the EuroQol 5 Dimension 5-level scale (EQ-5D-5L) [ Time Frame: 24 Hours Postdose ]
    Change from Baseline on the EQ-5D-5L

  16. Percentage of Participants Very Much or Much Better as Measured by the Patient Global Impression of Change (PGI-C) [ Time Frame: 2 Hours Postdose ]
    Percentage of Participants Very Much or Much Better as Measured by the PGI-C

  17. Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ) [ Time Frame: 24 Hours Postdose ]
    HRQoL Total Score as Measured by the 24-Hour MQoLQ



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Participants with migraine with or without aura fulfilling the International Classification of Headache Disorders (ICHD)-2.
  • History of disabling migraine for at least 1 year.
  • Migraine Disability Assessment Test (MIDAS) score ≥11.
  • Migraine onset before the age of 50 years.
  • History of 3-8 migraine attacks per month and <15 headache days per month during the past 3 months.

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 patient 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.

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): NCT03962738


Contacts
Layout table for location 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

Locations
Layout table for location information
Japan
Takanoko Hospital Not yet recruiting
Matsuyama-shi, Ehime, Japan, 790-0925
Contact    +81-120-36-0605      
Principal Investigator: Yasutaka Sadamoto         
Ikeda Neurosurgical Clinic Recruiting
Kasuga-shi, Fukuoka, Japan, 816 0824
Contact    +81-120-36-0605      
Principal Investigator: Koichi Ikeda         
Jinnouchi Neurosurgery Clinic Not yet recruiting
Kasuga-shi, Fukuoka, Japan, 816-0802
Contact    0925823232      
Principal Investigator: Takafumi Jinnouchi         
SUBARU Health Insurance Society Ota Memorial Hospital Not yet recruiting
Ota-shi, Gunma, Japan, 373-8585
Contact    +81-120-36-0605      
Principal Investigator: Tatsuya Monzen         
Nakamura Memorial Hospital Not yet recruiting
Sapporo, Hokkaido, Japan, 060-8570
Contact    +81-120-36-0605      
Principal Investigator: Atsuko Nihira         
Kohnan Hospital Recruiting
Kobe, Hyogo, Japan, 658-0064
Contact    +81-120-36-0605      
Principal Investigator: Shigekazu Kitamura         
Yamaguchi Clinic Not yet recruiting
Nishinomiya-shi, Hyogo, Japan, 663-8204
Contact    +81-120-36-0605      
Principal Investigator: Michio Yamaguchi         
Nishinomiya Municipal Central Hospital Recruiting
Nishinomiya, Hyogo, Japan, 663-8014
Contact    +81-120-36-0605      
Principal Investigator: Lynn Maeda         
Fujitsu Clinic Not yet recruiting
Kawasaki, Kanagawa, Japan, 211-8588
Contact    +81-120-36-0605      
Principal Investigator: Hisaka Igarashi         
Sendai Headache and Neurology Clinic Recruiting
Sendai, Miyagi, Japan, 982-0014
Contact    +81-120-36-0605      
Principal Investigator: Yasuhiko Matsumori         
Okayama City General Medical Center Okayama City Hospital Not yet recruiting
Okayama-shi, Okayama, Japan, 700-8557
Contact    +81-120-36-0605      
Principal Investigator: Hideki Kiriyama         
Saitama Medical University Hospital Not yet recruiting
Iruma-Gun, Saitama, Japan, 350-0495
Contact    +81-120-36-0605      
Principal Investigator: Toshimasa Yamamoto         
Saitama Neuropsychiatric Institute Not yet recruiting
Saitama City, Saitama, Japan, 338-8577
Contact    +81-120-36-0605      
Principal Investigator: Fumihiko Sakai         
Dokkyo Medical University Hospital Not yet recruiting
Shimotsuga-Gun, Tochigi, Japan, 321 0293
Contact    +81-120-36-0605      
Principal Investigator: Shiho Suzuki         
Niwa Family Clinic Recruiting
Chofu-shi, Tokyo, Japan, 182-0006
Contact    +81-120-36-0605      
Principal Investigator: Kiyoshi Niwa         
Tokyo Headache Clinic Recruiting
Shibuya-ku, Tokyo, Japan, 151-0051
Contact    +81-120-36-0605      
Principal Investigator: Nobuaki Shinohara         
Fukuuchi Pain Clinic Recruiting
Shinjuku-ku, Tokyo, Japan, 160-0017
Contact    +81-120-36-0605      
Principal Investigator: Yasuo Fukuuchi         
Sakura Clinic Internal Medicine Neurology Not yet recruiting
Toyama-Shi, Toyama, Japan, 9300803
Contact    +81-120-36-0605      
Principal Investigator: Hiroshi Matsuda         
Nagaseki Headache Clinic Recruiting
Kai-Shi, Yamanashi, Japan, 400-0124
Contact    +81-120-36-0605      
Principal Investigator: Yoshishige Nagaseki         
Doi Clinic Internal Medicine Neurology Recruiting
Hiroshima, Japan, 730-0031
Contact    +81-120-36-0605      
Principal Investigator: Hikaru Doi         
Tanaka neurosurgical clinic Recruiting
Kagoshima, Japan, 892-0844
Contact    +81-120-36-0605      
Principal Investigator: Shigeya Tanaka         
Umenotsuji Clinic Not yet recruiting
Kochi, Japan, 780-8011
Contact    +81-120-36-0605      
Principal Investigator: Hiroshi Yamada         
Kumamoto City Hospital Not yet recruiting
Kumamoto, Japan, 862-8505
Contact    +81-120-36-0605      
Principal Investigator: Yoichiro Hashimoto         
Tatsuoka Neurology Clinic Not yet recruiting
Kyoto, Japan, 600-8811
Contact    +81-120-36-0605      
Principal Investigator: Yoshihisa Tatsuoka         
Ishikawa Clinic Not yet recruiting
Kyoto, Japan, 606-0851
Contact    +81-120-36-0605      
Principal Investigator: Mitsunori Ishikawa         
Tominaga Hospital Not yet recruiting
Osaka, Japan, 5560017
Contact    +81-120-36-0605      
Principal Investigator: Takao Takeshima         
Japanese Red Cross Shizuoka Hospital Not yet recruiting
Shizuoka, Japan, 420-0853
Contact    +81-120-36-0605      
Principal Investigator: Noboru Imai         
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03962738     History of Changes
Other Study ID Numbers: 17012
H8H-JE-LAIH ( Other Identifier: Eli Lilly and Company )
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 15, 2019
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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: http://www.clinicalstudydatarequest.com

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

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