A Study Evaluating Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine

NCT ID: NCT04437433

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-18
• Study Completion Date: 2024-06-11

Brief Summary

This study will evaluate the long-term safety, efficacy and tolerability of atogepant 60 mg daily for the prevention of migraine in Japanese participants with chronic (CM) or episodic migraine (EM).

Detailed Description

The study recruited the following 2 cohorts:

3101-303-002 CM Completers: Japanese participants who completed lead-in Study 3101 303-002 (PROGRESS; NCT03855137), a Phase 3, multicenter, randomized, double-blind, placebo controlled, parallel-group study of atogepant for the prevention of CM. All 3101 303-002 CM Completers rolled over at Visit 7 (the end of the double-blind treatment period) of the lead-in study, which functioned as Visit 1 for this study, Study 3101-306-002.

De Novo EM Participants: Japanese participants with EM who were newly recruited for this study at selected sites. Participation began with a 4-week Screening/Baseline period starting at Visit -1, and those who completed the 4-week Screening/Baseline period and met all entry criteria were enrolled into the 52-week open-label treatment period at Visit 1.

Conditions

Chronic Migraine; Episodic Migraine

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Atogepant 60 mg Chronic Migraine

Participants with chronic migraine (CM) who completed lead-in Study 3101-303-002 (NCT03855137) received atogepant orally as 60 mg tablets once a day (QD) for 52 weeks.

Group Type: EXPERIMENTAL

Atogepant 60 mg

Intervention Type: DRUG

Tablets containing 60 mg atogepant

Atogepant 60 mg Episodic Migraine

Participants with episodic migraine (EM) who were newly recruited and met all study entry criteria received atogepant orally as 60 mg tablets once a day (QD) for 52 weeks.

Group Type: EXPERIMENTAL

Atogepant 60 mg

Intervention Type: DRUG

Tablets containing 60 mg atogepant

Interventions

Atogepant 60 mg

Tablets containing 60 mg atogepant

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

3101-303-002 Completers:

• Eligible participants who completed Visit 7, and Visit 8 if applicable, of the Study 3101-303-002 without significant protocol deviations and who did not experience an adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable safety risk.

De Novo EM Participants:

• Age of the participant at the time of migraine onset < 50 years.
• At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3, 2018.
• History of 4 to 14 migraine days per month on average in the 3 months prior to Visit -1 in the investigator's judgment.
• 4 to 14 migraine days in the 28-day baseline period per eDiary.
• Completed at least 20 out of 28 days in the eDiary during baseline period and is able to read, understand, and complete the study questionnaires and eDiary per investigator's judgment.

Exclusion Criteria

• Requirement for any medication, diet, or nonpharmacological treatment that is on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative medication or treatment.
• Participants with an ECG indicating clinically significant abnormalities at Visit -1 (De Novo EM Participants) or Visit 1 (3103-303-002 Completers).
• Hypertension as defined by sitting systolic BP > 160 mm Hg or sitting diastolic BP > 100 mm Hg at Visit -1 (De Novo EM Participants) or Visit 1 (for all participants)
• Significant risk of self-harm based on clinical interview and responses on the Columbia-Suicide Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator.
• Any clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

De Novo EM Participants only:

• Difficulty distinguishing migraine headaches from tension-type or other headaches.
• Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine as defined by ICHD-3, 2018.
• Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3, 2018.
• Has >= 15 headache days per month on average across the 3 months prior to Visit -1 in the investigator's judgment.
• Has >= 15 headache days in the 28-day baseline period per eDiary.
• Usage of opioids or barbiturates > 2 days/month, triptans or ergots >= 10 days/month, or simple analgesics >= 15 days/month in the 3 months prior to Visit -1 per investigator's judgment or during the baseline period.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Takanoko Hospital /ID# 232723

Matsuyama, Ehime, Japan

Fukuiken Saiseikai Hospital /ID# 232988

Fukui-shi, Fukui, Japan

Duplicate_Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 232710

Sapporo, Hokkaido, Japan

Konan Medical Center /ID# 232922

Kobe, Hyōgo, Japan

Mito Kyodo General Hospital /ID# 232990

Mito, Ibaraki, Japan

Atsuchi Neurosurgical Hospital /ID# 232907

Kagoshima, Kagoshima-ken, Japan

Duplicate_Tokai University Hospital /ID# 233071

Isehara-shi, Kanagawa, Japan

Fujitsu Clinic /ID# 232717

Kawasaki-shi, Kanagawa, Japan

Umenotsuji Clinic /ID# 232675

Kochi, Kochi, Japan

Sendai Headache and Neurology Clinic Medical Corporation /ID# 232677

Sendai, Miyagi, Japan

Saitama Medical University Hospital /ID# 233017

Iruma-gun, Saitama, Japan

Saitama Neuropsychiatric Institute /Id# 232711

Saitama-shi, Saitama, Japan

Japanese Red Cross Shizuoka Hospital /ID# 232992

Shizuoka, Shizuoka, Japan

Duplicate_Dokkyo Medical University Hospital /ID# 232995

Shimotsuga-gun, Tochigi, Japan

Niwa Family Clinic /ID# 232713

Chofu-shi, Tokyo, Japan

Duplicate_Tokyo Headache Clinic /ID# 232715

Shibuya-ku, Tokyo, Japan

Keio University Hospital /ID# 233030

Shinjuku-ku, Tokyo, Japan

Duplicate_Nagaseki Headache Clinic /ID# 232719

Kai-shi, Yamanashi, Japan

DOI Internal Medicine-Neurology Clinic /ID# 232722

Hiroshima, , Japan

Hiroshima Neurology Clinic /ID# 232720

Hiroshima, , Japan

Tanaka Neurosurgical Clinic /ID# 232884

Kagoshima, , Japan

Tatsuoka Neurology Clinic /ID# 232912

Kyoto, , Japan

Tominaga Hospital /ID# 232909

Osaka, , Japan

Shinagawa Strings Clinic /ID# 232908

Tokyo, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.abbvieclinicaltrials.com/study/?id=3101-306-002

Related Info

Other Identifiers

3101-306-002

Identifier Type: -

Identifier Source: org_study_id