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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05861427
Other study ID # M22-056
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date July 12, 2023
Est. completion date May 28, 2025

Study information

Verified date November 2023
Source AbbVie
Contact AbbVie GK Clinical Trial Registration Desk
Phone +81-3-4577-1111
Email abbvie_jpn_info_clingov@abbvie.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 50 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 520
Est. completion date May 28, 2025
Est. primary completion date January 24, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Atogepant
Oral Tablet
Placebo for Atogepant
Oral Tablet

Locations

Country Name City State
Japan Fukuiken Saiseikai Hospital /ID# 245662 Fukui-shi Fukui
Japan Tokai University Hachioji Hospital /ID# 248326 Hachioji-shi Tokyo
Japan DOI Internal Medicine-Neurology Clinic /ID# 245661 Hiroshima
Japan Hiroshima City Hiroshima Citizens Hospital /ID# 246683 Hiroshima-shi Hiroshima
Japan Tokyo Dental College Ichikawa General Hospital /ID# 247436 Ichikawa-shi Chiba
Japan Saitama Medical University Hospital /ID# 245663 Iruma-gun Saitama
Japan Tokai University Hospital /ID# 245971 Isehara-shi Kanagawa
Japan Tanaka Neurosurgical clinic /ID# 245488 Kagoshima
Japan Kijima Neurosurgery Clinic /ID# 245758 Kahoku-gun Ishikawa
Japan Nagaseki Headache Clinic /ID# 245485 Kai-shi Yamanashi
Japan Ikeda Neurosurgical Clinic /ID# 245881 Kasuga-shi Fukuoka
Japan Jinnouchi Neurosurgical Clinic /ID# 245510 Kasuga-shi Fukuoka
Japan Fujitsu Clinic /ID# 245811 Kawasaki-shi Kanagawa
Japan Konan Medical Center /ID# 245557 Kobe-shi Hyogo
Japan Atago Hospital /ID# 245818 Kochi-shi Kochi
Japan Umenotsuji Clinic /ID# 246103 Kochi-shi Kochi
Japan Saiseikai Kumamoto Hospital /Id# 253546 Kumamoto-shi Kumamoto
Japan Tatsuoka Neurology Clinic /ID# 245328 Kyoto
Japan Takanoko Hospital /ID# 245658 Matsuyama-shi Ehime
Japan Kitasato University Kitasato Institute Hospital /ID# 246470 Minato-ku Tokyo
Japan Mito Kyodo General Hospital /ID# 245487 Mito-shi Ibaraki
Japan Nishinomiya Municipal Central Hospital /ID# 246571 Nishinomiya-shi Hyogo
Japan Yamaguchi Clinic /ID# 246370 Nishinomiya-shi Hyogo
Japan Kanazawa Neurosurgical Hospital /ID# 254210 Nonoichi-shi Ishikawa
Japan Ooba Clinic for Neurosurgery & Headache /ID# 246201 Oita-shi
Japan Makabe Clinic /ID# 246621 Okayama-shi Okayama
Japan Okayama City General Medical Center /ID# 246007 Okayama-shi Okayama
Japan Chibune General Hospital /ID# 245973 Osaka-shi Osaka
Japan Gokeikai Osaka Kaisei Hospital /ID# 246623 Osaka-shi Osaka
Japan Tominaga Clinic /ID# 245812 Osaka-shi Osaka
Japan SUBARU Health Insurance Society Ota Memorial Hospital /ID# 247948 Ota-shi Gunma
Japan Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 245667 Sapporo-shi Hokkaido
Japan Nakamura Memorial Hospital /ID# 247379 Sapporo-shi Hokkaido
Japan Narikawa Neurological Clinic /ID# 254023 Sendai-shi Miyagi
Japan Sendai Headache and Neurology Clinic Medical Corporation /ID# 245664 Sendai-shi Miyagi
Japan Usuda Clinic Of Internal Medicine /ID# 246166 Setagaya-ku Tokyo
Japan Tokyo Headache Clinic /ID# 245486 Shibuya-ku Tokyo
Japan Dokkyo Medical University Hospital /ID# 246472 Shimotsuga-gun Tochigi
Japan Keio University Hospital /ID# 245660 Shinjuku-ku Tokyo
Japan Japanese Red Cross Shizuoka Hospital /ID# 246204 Shizuoka-shi Shizuoka
Japan Suzuki Kei Yasuragi Clinic /ID# 253493 Tachikawa-shi Tokyo
Japan Kokubu Clinic /ID# 245810 Takamatsu
Japan Tendo Brain Clinic /ID# 246205 Tendo-shi Yamagata
Japan Saino Clinic /ID# 245921 Tokorozawa-shi Saitama
Japan Shinagawa Strings Clinic /ID# 245665 Tokyo
Japan Sakura neuro Clinic /ID# 248320 Toyama City Toyama
Japan Takase Internal Medicine Clinic /ID# 245532 Toyonaka-shi Osaka
Japan Tsukuba Neurosurgery/Headache Clinic /ID# 254665 Tsukuba-shi Ibaraki

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Mean Monthly Migraine Days A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary. Up to 12 Weeks
Secondary Change From Baseline in Mean Monthly Headache Days 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. Up to Week 12
Secondary Change From Baseline in Mean Monthly Acute Medication Use Days 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. Up to Week 12
Secondary Percentage of Participants Achieving At Least 50% Reduction in the 3-month Average of Monthly Migraine Days A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary. Up to Week 12
Secondary Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score 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. Up to Week 12
Secondary Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine - Diary (AIM-D) 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. Up to Week 12
Secondary Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D 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. Up to Week 12
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