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Release: Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine

Sponsor
AbbVie (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05861427
Collaborator
(none)
520
Enrollment
50
Locations
4
Arms
23.5
Anticipated Duration (Months)
10.4
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. This study will assess how safe and effective three different doses of atogepant is compared to placebo in adult Japanese participants. Change in migraine symptoms will be assessed.

Atogepant (Qulipta) is an approved drug to treat adults with episodic migraine in the United States. Participants are randomly assigned to one of the 4 treatment groups called Arms to receive atogepant or matching placebo. There is 1 in a 4 chance for the participant to receive placebo. This is double-blinded study which means neither study doctor not the participant will know if the participant received atogepant or placebo. Approximately 520 adult participants with episodic migraine will be enrolled in approximately 45 sites across Japan.

Participants will receive oral atogepant or matching placebo tablets once daily for 12 weeks. At 12 weeks participants assigned to atogepant dose A, dose B or dose C will continue to receive same treatment for 12 additional weeks and participants assigned to placebo will be re-randomized to receive atogepant dose A, dose B or dose C for 12 additional weeks. All participants will be followed for 30 days following last dose of study drug.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
520 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study With An Active Treatment Extension to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prevention of Migraine in Japanese Subjects With Episodic Migraine
Anticipated Study Start Date :
May 30, 2023
Anticipated Primary Completion Date :
Jan 24, 2025
Anticipated Study Completion Date :
May 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Atogepant Dose A

Participants will receive atogepant dose A once daily (QD) for 24 weeks.

Drug: Atogepant
Oral Tablet
Other Names:
  • Qulipta

    		•
    Experimental: Atogepant Dose B

    Participants will receive atogepant dose B QD for 24 weeks.

    Drug: Atogepant
    Oral Tablet
    Other Names:
  • Qulipta

    		•
    Experimental: Atogepant Dose C

    Participants will receive atogepant dose C QD for 24 weeks.

    Drug: Atogepant
    Oral Tablet
    Other Names:
  • Qulipta

    		•
    Experimental: Placebo

    Participants will receive placebo QD for 12 weeks. Participants will be re-randomized at week 12 to receive atogepant dose A, dose B or dose C QD for 12 weeks.

    Drug: Atogepant
    Oral Tablet
    Other Names:
  • Qulipta

    • Drug: Placebo for Atogepant
    Oral Tablet

    Outcome Measures

    Primary Outcome Measures

    1. Change From Baseline in Mean Monthly Migraine Days [Up to 12 Weeks]

      A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.

    Secondary Outcome Measures

    1. Change From Baseline in Mean Monthly Headache Days [Up to Week 12]

      A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication was used after the start of the headache, in which case no minimum duration will be specified.

    2. Change From Baseline in Mean Monthly Acute Medication Use Days [Up to Week 12]

      An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine.

    3. Percentage of Participants Achieving At Least 50% Reduction in the 3-month Average of Monthly Migraine Days [Up to Week 12]

      A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary.

    4. Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score [Up to Week 12]

      MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into three domains: Role Function Restrictive, Role Function Preventive, and Emotional Function domain. Participants respond to items using a 6-point scale ranging from "none of the time" to "all of the time." Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life.

    5. Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine - Diary (AIM-D) [Up to Week 12]

      The AIM-D is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items). Participants are asked to rate the level of difficulty experienced in the past 24 hours with performance of daily activities and physical impairment using a 6 point rating scale ranging from "Not difficult at all" to "I could not do it at all." Scores range from 0-100 scale, with higher scores indicating greater impact of migraine.

    6. Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D [Up to Week 12]

      The AIM-D is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items). Participants are asked to rate the level of difficulty experienced in the past 24 hours with performance of daily activities and physical impairment using a 6 point rating scale ranging from "Not difficult at all" to "I could not do it at all." Scores range from 0-100 scale, with higher scores indicating greater impact of migraine.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • At least a 1-year history of migraine (with or without aura).

    • Less than 50 years of age at the time of migraine onset.

    • History of 4 to 14 migraine days per month in the 3 months prior to screening.

    • 4 to 14 migraine days in the baseline period and completed at least 20 out of 28 days at the baseline period per the eDiary.

    Exclusion Criteria:

    • Difficulty with distinguishing migraine headaches from tension-type or other headaches.

    • Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tokyo Dental College Ichikawa General Hospital /ID# 247436 Ichikawa-shi Chiba Japan 272-0824
    2 Takanoko Hospital /ID# 245658 Matsuyama-shi Ehime Japan 790-0925
    3 Fukuiken Saiseikai Hospital /ID# 245662 Fukui-shi Fukui Japan 918-8503
    4 Jinnouchi Neurosurgical Clinic /ID# 245510 Kasuga-shi Fukuoka Japan 816-0802
    5 Ikeda Neurosurgical Clinic /ID# 245881 Kasuga-shi Fukuoka Japan 816-0824
    6 SUBARU Health Insurance Society Ota Memorial Hospital /ID# 247948 Ota-shi Gunma Japan 373-8585
    7 Hiroshima City Hiroshima Citizens Hospital /ID# 246683 Hiroshima-shi Hiroshima Japan 730-8518
    8 MUKAI Neurology clinic) /ID# 254209 Hiroshima-shi Hiroshima Japan 7360085
    9 Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 245667 Sapporo-shi Hokkaido Japan 003-0003
    10 Nakamura Memorial Hospital /ID# 247379 Sapporo-shi Hokkaido Japan 060-8570
    11 Konan Medical Center /ID# 245557 Kobe-shi Hyogo Japan 658-0064
    12 Nishinomiya Municipal Central Hospital /ID# 246571 Nishinomiya-shi Hyogo Japan 663-8014
    13 Yamaguchi Clinic /ID# 246370 Nishinomiya-shi Hyogo Japan 663-8204
    14 Mito Kyodo General Hospital /ID# 245487 Mito-shi Ibaraki Japan 310-0015
    15 Tsukuba Neurosurgery/Headache Clinic /ID# 254665 Tsukuba-shi Ibaraki Japan 305-0822
    16 Kijima Neurosurgery Clinic /ID# 245758 Kahoku-gun Ishikawa Japan 929-0342
    17 Kanazawa Neurosurgical Hospital /ID# 254210 Nonoichi-shi Ishikawa Japan 921-8841
    18 Tokai University Hospital /ID# 245971 Isehara-shi Kanagawa Japan 259-1193
    19 Fujitsu Clinic /ID# 245811 Kawasaki-shi Kanagawa Japan 211-8588
    20 Atago Hospital /ID# 245818 Kochi-shi Kochi Japan 780-0051
    21 Umenotsuji Clinic /ID# 246103 Kochi-shi Kochi Japan 780-8011
    22 Saiseikai Kumamoto Hospital /Id# 253546 Kumamoto-shi Kumamoto Japan 861-4101
    23 Narikawa Neurological Clinic /ID# 254023 Sendai-shi Miyagi Japan 981-3126
    24 Sendai Headache and Neurology Clinic Medical Corporation /ID# 245664 Sendai-shi Miyagi Japan 982-0014
    25 National Hospital Organization Saigata Medical Center /ID# 254479 Joetsu-shi Niigata Japan 949-3193
    26 Makabe Clinic /ID# 246621 Okayama-shi Okayama Japan 700-0964
    27 Okayama City General Medical Center /ID# 246007 Okayama-shi Okayama Japan 700-8557
    28 Gokeikai Osaka Kaisei Hospital /ID# 246623 Osaka-shi Osaka Japan 532-0003
    29 Chibune General Hospital /ID# 245973 Osaka-shi Osaka Japan 555-0034
    30 Tominaga Clinic /ID# 245812 Osaka-shi Osaka Japan 5560015
    31 Takase Internal Medicine Clinic /ID# 245532 Toyonaka-shi Osaka Japan 560-0012
    32 Saitama Medical University Hospital /ID# 245663 Iruma-gun Saitama Japan 350-0495
    33 Saino Clinic /ID# 245921 Tokorozawa-shi Saitama Japan 359-1141
    34 Japanese Red Cross Shizuoka Hospital /ID# 246204 Shizuoka-shi Shizuoka Japan 420-0853
    35 Dokkyo Medical University Hospital /ID# 246472 Shimotsuga-gun Tochigi Japan 321-0293
    36 Tokai University Hachioji Hospital /ID# 248326 Hachioji-shi Tokyo Japan 192-0032
    37 Kitasato University Kitasato Institute Hospital /ID# 246470 Minato-ku Tokyo Japan 108-8642
    38 Usuda Clinic Of Internal Medicine /ID# 246166 Setagaya-ku Tokyo Japan 156-0043
    39 Tokyo Headache Clinic /ID# 245486 Shibuya-ku Tokyo Japan 151-0051
    40 Keio University Hospital /ID# 245660 Shinjuku-ku Tokyo Japan 160-8582
    41 Suzuki Kei Yasuragi Clinic /ID# 253493 Tachikawa-shi Tokyo Japan 190-0001
    42 Sakura Clinic /ID# 248320 Toyama City Toyama Japan 930-0803
    43 Tendo Brain Clinic /ID# 246205 Tendo-shi Yamagata Japan 994-0083
    44 Nagaseki Headache Clinic /ID# 245485 Kai-shi Yamanashi Japan 400-0124
    45 DOI Internal Medicine-Neurology Clinic /ID# 245661 Hiroshima Japan 730-0031
    46 Tanaka Neurosurgical clinic /ID# 245488 Kagoshima Japan 892-0844
    47 Tatsuoka Neurology Clinic /ID# 245328 Kyoto Japan 600-8811
    48 Ooba Clinic for Neurosurgery & Headache /ID# 246201 Oita-shi Japan 8700831
    49 Kokubu Clinic /ID# 245810 Takamatsu Japan 769-0103
    50 Shinagawa Strings Clinic /ID# 245665 Tokyo Japan 108-0075

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT05861427
    Other Study ID Numbers:
    • M22-056
    First Posted:
    May 16, 2023
    Last Update Posted:
    May 16, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by AbbVie
    Migraine
    Episodic Migraine
    Atogepant
    Additional relevant MeSH terms:
    Migraine Disorders

    Study Results

    No Results Posted as of May 16, 2023