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Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine
Sponsor: AbbVie
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.
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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
524
Start Date
2023-07-12
Completion Date
2025-03-01
Last Updated
2026-06-11
Healthy Volunteers
No
Conditions
Interventions
Atogepant
Oral Tablet
Placebo for Atogepant
Oral Tablet
Locations (48)
Tokyo Dental College Ichikawa General Hospital /ID# 247436
Ichikawa-shi, Chiba, Japan
Takanoko Hospital /ID# 245658
Matsuyama, Ehime, Japan
Fukuiken Saiseikai Hospital /ID# 245662
Fukui-shi, Fukui, Japan
Jinnouchi Neurosurgical Clinic /ID# 245510
Kasuga-shi, Fukuoka, Japan
Ikeda Neurosurgical Clinic /ID# 245881
Kasuga-shi, Fukuoka, Japan
SUBARU Health Insurance Society Ota Memorial Hospital /ID# 247948
Ota-shi, Gunma, Japan
Hiroshima City Hiroshima Citizens Hospital /ID# 246683
Hiroshima, Hiroshima, Japan
Higashi Sapporo Neurology And Neurosurgery Clinic /ID# 245667
Sapporo, Hokkaido, Japan
Nakamura Memorial Hospital /ID# 247379
Sapporo, Hokkaido, Japan
Konan Medical Center /ID# 245557
Kobe, Hyōgo, Japan
Nishinomiya Municipal Central Hospital /ID# 246571
Nishinomiya-shi, Hyōgo, Japan
Yamaguchi Clinic /ID# 246370
Nishinomiya-shi, Hyōgo, Japan
Mito Kyodo General Hospital /ID# 245487
Mito, Ibaraki, Japan
Tsukuba Neurosurgery/Headache Clinic /ID# 254665
Tsukuba, Ibaraki, Japan
Kijima Neurosurgery Clinic /ID# 245758
Kahoku-gun, Ishikawa-ken, Japan
Kanazawa Neurosurgical Hospital /ID# 254210
Nonoichi-shi, Ishikawa-ken, Japan
Kokubu Clinic /ID# 245810
Takamatsu, Kagawa-ken, Japan
Tokai University Hospital /ID# 245971
Isehara, Kanagawa, Japan
Fujitsu Clinic /ID# 245811
Kawasaki-shi, Kanagawa, Japan
Atago Hospital /ID# 245818
Kochi, Kochi, Japan
Umenotsuji Clinic /ID# 246103
Kochi, Kochi, Japan
Saiseikai Kumamoto Hospital /Id# 253546
Kumamoto, Kumamoto, Japan
Narikawa Neurological Clinic /ID# 254023
Sendai, Miyagi, Japan
Sendai Headache and Neurology Clinic Medical Corporation /ID# 245664
Sendai, Miyagi, Japan
Ooba Clinic for Neurosurgery & Headache /ID# 246201
Ōita, Oita Prefecture, Japan
Makabe Clinic /ID# 246621
Okayama, Okayama-ken, Japan
Okayama City General Medical Center /ID# 246007
Okayama, Okayama-ken, Japan
Gokeikai Osaka Kaisei Hospital /ID# 246623
Osaka, Osaka, Japan
Chibune General Hospital /ID# 245973
Osaka, Osaka, Japan
Tominaga Clinic /ID# 245812
Osaka, Osaka, Japan
Takase Internal Medicine Clinic /ID# 245532
Toyonaka-shi, Osaka, Japan
Saitama Medical University Hospital /ID# 245663
Iruma-gun, Saitama, Japan
Saino Clinic /ID# 245921
Tokorozawa-shi, Saitama, Japan
Japanese Red Cross Shizuoka Hospital /ID# 246204
Shizuoka, Shizuoka, Japan
Dokkyo Medical University Hospital /ID# 246472
Mibu, Tochigi, Japan
Tokai University Hachioji Hospital /ID# 248326
Hachioji-shi, Tokyo, Japan
Kitasato University Kitasato Institute Hospital /ID# 246470
Minato-ku, Tokyo, Japan
Usuda Clinic Of Internal Medicine /ID# 246166
Setagaya-ku, Tokyo, Japan
Tokyo Headache Clinic /ID# 245486
Shibuya-ku, Tokyo, Japan
Keio University Hospital /ID# 245660
Shinjuku-ku, Tokyo, Japan
Suzuki Kei Yasuragi Clinic /ID# 253493
Tachikawa-shi, Tokyo, Japan
Sakura neuro Clinic /ID# 248320
Toyama, Toyama, Japan
Tendo Brain Clinic /ID# 246205
Tendo-shi, Yamagata, Japan
Nagaseki Headache Clinic /ID# 245485
Kai, Yamanashi, Japan
DOI Internal Medicine-Neurology Clinic /ID# 245661
Hiroshima, Japan
Tanaka Neurosurgery & Headache Clinic /ID# 245488
Kagoshima, Japan
Tatsuoka Neurology Clinic /ID# 245328
Kyoto, Japan
Shinagawa Strings Clinic /ID# 245665
Tokyo, Japan