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

NCT05861427 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: M22-056
• Study Type: interventional
• Target: 523
• Locations: 1 country
• Sites: 48

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.

Conditions

Migraine

Keywords

Migraine; Episodic Migraine; Atogepant

Outcome Measures

Primary Outcomes (2)

• 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

• Number of Participants Experiencing With Adverse Events (AEs)

  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.

  Up to approximately 28 Weeks

Secondary Outcomes (6)

• Change From Baseline in Mean Monthly Headache Days

  Up to Week 12

• Change From Baseline in Mean Monthly Acute Medication Use Days

  Up to Week 12

• Percentage of Participants Achieving At Least 50% Reduction in the 3-month Average of Monthly Migraine Days

  Up to Week 12

• 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

• 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

Study Arms (4)

Atogepant Dose A

EXPERIMENTAL

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

Drug: Atogepant

Atogepant Dose B

EXPERIMENTAL

Participants will receive atogepant dose B QD for 24 weeks.

Drug: Atogepant

Atogepant Dose C

EXPERIMENTAL

Participants will receive atogepant dose C QD for 24 weeks.

Drug: Atogepant

Placebo

EXPERIMENTAL

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; Drug: Placebo for Atogepant

Interventions

Atogepant DRUG

Oral Tablet

Also known as: Qulipta

Atogepant Dose A; Atogepant Dose B; Atogepant Dose C; Placebo

Placebo for Atogepant DRUG

Oral Tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Difficulty with distinguishing migraine headaches from tension-type or other headaches.
• Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (48)

Tokyo Dental College Ichikawa General Hospital /ID# 247436

Ichikawa-shi, Chiba, 272-0824, Japan

Location

Takanoko Hospital /ID# 245658

Matsuyama, Ehime, 790-0925, Japan

Location

Fukuiken Saiseikai Hospital /ID# 245662

Fukui-shi, Fukui, 918-8503, Japan

Location

Jinnouchi Neurosurgical Clinic /ID# 245510

Kasuga-shi, Fukuoka, 816-0802, Japan

Location

Ikeda Neurosurgical Clinic /ID# 245881

Kasuga-shi, Fukuoka, 816-0824, Japan

Location

SUBARU Health Insurance Society Ota Memorial Hospital /ID# 247948

Ota-shi, Gunma, 373-8585, Japan

Location

Hiroshima City Hiroshima Citizens Hospital /ID# 246683

Hiroshima, Hiroshima, 730-8518, Japan

Location

Higashi Sapporo Neurology And Neurosurgery Clinic /ID# 245667

Sapporo, Hokkaido, 003-0003, Japan

Location

Nakamura Memorial Hospital /ID# 247379

Sapporo, Hokkaido, 060-8570, Japan

Location

Konan Medical Center /ID# 245557

Kobe, Hyōgo, 658-0064, Japan

Location

Nishinomiya Municipal Central Hospital /ID# 246571

Nishinomiya-shi, Hyōgo, 663-8014, Japan

Location

Yamaguchi Clinic /ID# 246370

Nishinomiya-shi, Hyōgo, 663-8204, Japan

Location

Mito Kyodo General Hospital /ID# 245487

Mito, Ibaraki, 310-0015, Japan

Location

Tsukuba Neurosurgery/Headache Clinic /ID# 254665

Tsukuba, Ibaraki, 305-0822, Japan

Location

Kijima Neurosurgery Clinic /ID# 245758

Kahoku-gun, Ishikawa-ken, 929-0342, Japan

Location

Kanazawa Neurosurgical Hospital /ID# 254210

Nonoichi-shi, Ishikawa-ken, 921-8841, Japan

Location

Tokai University Hospital /ID# 245971

Isehara, Kanagawa, 259-1193, Japan

Location

Fujitsu Clinic /ID# 245811

Kawasaki-shi, Kanagawa, 211-8588, Japan

Location

Atago Hospital /ID# 245818

Kochi, Kochi, 780-0051, Japan

Location

Umenotsuji Clinic /ID# 246103

Kochi, Kochi, 780-8011, Japan

Location

Saiseikai Kumamoto Hospital /Id# 253546

Kumamoto, Kumamoto, 861-4101, Japan

Location

Narikawa Neurological Clinic /ID# 254023

Sendai, Miyagi, 981-3126, Japan

Location

Sendai Headache and Neurology Clinic Medical Corporation /ID# 245664

Sendai, Miyagi, 982-0014, Japan

Location

Makabe Clinic /ID# 246621

Okayama, Okayama-ken, 700-0964, Japan

Location

Okayama City General Medical Center /ID# 246007

Okayama, Okayama-ken, 700-8557, Japan

Location

Gokeikai Osaka Kaisei Hospital /ID# 246623

Osaka, Osaka, 532-0003, Japan

Location

Chibune General Hospital /ID# 245973

Osaka, Osaka, 555-0034, Japan

Location

Tominaga Clinic /ID# 245812

Osaka, Osaka, 5560015, Japan

Location

Takase Internal Medicine Clinic /ID# 245532

Toyonaka-shi, Osaka, 560-0012, Japan

Location

Saitama Medical University Hospital /ID# 245663

Iruma-gun, Saitama, 350-0495, Japan

Location

Saino Clinic /ID# 245921

Tokorozawa-shi, Saitama, 359-1141, Japan

Location

Japanese Red Cross Shizuoka Hospital /ID# 246204

Shizuoka, Shizuoka, 420-0853, Japan

Location

Dokkyo Medical University Hospital /ID# 246472

Mibu, Tochigi, 321-0293, Japan

Location

Tokai University Hachioji Hospital /ID# 248326

Hachioji-shi, Tokyo, 192-0032, Japan

Location

Kitasato University Kitasato Institute Hospital /ID# 246470

Minato-ku, Tokyo, 108-8642, Japan

Location

Usuda Clinic Of Internal Medicine /ID# 246166

Setagaya-ku, Tokyo, 156-0043, Japan

Location

Tokyo Headache Clinic /ID# 245486

Shibuya-ku, Tokyo, 151-0051, Japan

Location

Keio University Hospital /ID# 245660

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Suzuki Kei Yasuragi Clinic /ID# 253493

Tachikawa-shi, Tokyo, 190-0001, Japan

Location

Sakura neuro Clinic /ID# 248320

Toyama, Toyama, 930-0803, Japan

Location

Tendo Brain Clinic /ID# 246205

Tendo-shi, Yamagata, 994-0083, Japan

Location

Nagaseki Headache Clinic /ID# 245485

Kai, Yamanashi, 400-0124, Japan

Location

DOI Internal Medicine-Neurology Clinic /ID# 245661

Hiroshima, 730-0031, Japan

Location

Tanaka Neurosurgical Clinic /ID# 245488

Kagoshima, 892-0844, Japan

Location

Tatsuoka Neurology Clinic /ID# 245328

Kyoto, 600-8811, Japan

Location

Ooba Clinic for Neurosurgery & Headache /ID# 246201

Ōita, 8700831, Japan

Location

Kokubu Clinic /ID# 245810

Takamatsu, 769-0103, Japan

Location

Shinagawa Strings Clinic /ID# 245665

Tokyo, 108-0075, Japan

Location

Related Publications (1)

• Matsumori Y, Yamada H, Nagaseki Y, Shimizu K, Nagy K, Matsuzawa R, Otani T, He MY, Guo H, Ahmadyar G, Takeshima T. Atogepant for the preventive treatment of episodic migraine in Japanese participants: A phase 2/3, randomized, double-blind, placebo-controlled trial with an active treatment extension (RELEASE). Cephalalgia. 2025 Sep;45(9):3331024251374569. doi: 10.1177/03331024251374569. Epub 2025 Sep 26.

  PMID: 41002192 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Migraine Disorders

Interventions

atogepant

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 16, 2023
• Study Start: July 12, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

JP (48)