Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine
- Registration Number
- NCT05861427
- Lead Sponsor
- AbbVie
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 523
- 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.
- Difficulty with distinguishing migraine headaches from tension-type or other headaches.
- Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Atogepant 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. Atogepant Dose A Atogepant Participants will receive atogepant dose A once daily (QD) for 24 weeks. Placebo Placebo for Atogepant 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. Atogepant Dose B Atogepant Participants will receive atogepant dose B QD for 24 weeks. Atogepant Dose C Atogepant Participants will receive atogepant dose C QD for 24 weeks.
- Primary Outcome Measures
Name Time Method 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.
Number of Participants Experiencing With Adverse Events (AEs) Up to approximately 28 Weeks An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
- Secondary Outcome Measures
Name Time Method 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.
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.
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.
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.
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.
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.
Trial Locations
- Locations (48)
Konan Medical Center /ID# 245557
🇯🇵Kobe-shi, Hyogo, Japan
Nishinomiya Municipal Central Hospital /ID# 246571
🇯🇵Nishinomiya-shi, Hyogo, Japan
Yamaguchi Clinic /ID# 246370
🇯🇵Nishinomiya-shi, Hyogo, Japan
Mito Kyodo General Hospital /ID# 245487
🇯🇵Mito-shi, Ibaraki, Japan
Tsukuba Neurosurgery/Headache Clinic /ID# 254665
🇯🇵Tsukuba-shi, Ibaraki, Japan
Kijima Neurosurgery Clinic /ID# 245758
🇯🇵Kahoku-gun, Ishikawa, Japan
Kanazawa Neurosurgical Hospital /ID# 254210
🇯🇵Nonoichi-shi, Ishikawa, Japan
Tokai University Hospital /ID# 245971
🇯🇵Isehara, Kanagawa, Japan
Fujitsu Clinic /ID# 245811
🇯🇵Kawasaki-shi, Kanagawa, 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
Narikawa Neurological Clinic /ID# 254023
🇯🇵Sendai-shi, Miyagi, Japan
Sendai Headache and Neurology Clinic Medical Corporation /ID# 245664
🇯🇵Sendai-shi, Miyagi, Japan
Makabe Clinic /ID# 246621
🇯🇵Okayama-shi, Okayama, Japan
Okayama City General Medical Center /ID# 246007
🇯🇵Okayama-shi, Okayama, Japan
Gokeikai Osaka Kaisei Hospital /ID# 246623
🇯🇵Osaka-shi, Osaka, Japan
Chibune General Hospital /ID# 245973
🇯🇵Osaka-shi, Osaka, Japan
Tominaga Clinic /ID# 245812
🇯🇵Osaka-shi, 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-shi, 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 City, 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 Neurosurgical Clinic /ID# 245488
🇯🇵Kagoshima, Japan
Tatsuoka Neurology Clinic /ID# 245328
🇯🇵Kyoto, Japan
Ooba Clinic for Neurosurgery & Headache /ID# 246201
🇯🇵Oita-shi, Japan
Kokubu Clinic /ID# 245810
🇯🇵Takamatsu, Japan
Shinagawa Strings Clinic /ID# 245665
🇯🇵Tokyo, Japan
SUBARU Health Insurance Society Ota Memorial Hospital /ID# 247948
🇯🇵Ota-shi, Gunma, Japan
Hiroshima City Hiroshima Citizens Hospital /ID# 246683
🇯🇵Hiroshima-shi, Hiroshima, Japan
Nakamura Memorial Hospital /ID# 247379
🇯🇵Sapporo-shi, Hokkaido, Japan
Higashi Sapporo Neurology And Neurosurgery Clinic /ID# 245667
🇯🇵Sapporo-shi, Hokkaido, Japan
Tokyo Dental College Ichikawa General Hospital /ID# 247436
🇯🇵Ichikawa-shi, Chiba, Japan
Takanoko Hospital /ID# 245658
🇯🇵Matsuyama-shi, 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