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

NCT04437433 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 3101-306-002
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 24

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).

Conditions

Chronic Migraine; Episodic Migraine

Keywords

Chronic Migraine; Episodic Migraine; Atogepant

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs)

  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. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

  From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks)

Secondary Outcomes (5)

• Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator

  From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks)

• Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator

  Week -4 (De Novo Participants), Day 1 (3101-303-002 Completers Only), Weeks 12, 24, 36, and 52

• Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator

  From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks)

• Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period

  From first dose of study drug until the last dose of study drug (up to 52 weeks)

• Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Safety Follow-Up Period

  Up to 4 weeks following the last dose of study drug

Study Arms (2)

Atogepant 60 mg Chronic Migraine

EXPERIMENTAL

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.

Drug: Atogepant 60 mg

Atogepant 60 mg Episodic Migraine

EXPERIMENTAL

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.

Drug: Atogepant 60 mg

Interventions

Atogepant 60 mg DRUG

Tablets containing 60 mg atogepant

Atogepant 60 mg Chronic Migraine; Atogepant 60 mg Episodic Migraine

Eligibility Criteria

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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (24)

Takanoko Hospital /ID# 232723

Matsuyama, Ehime, 790-0925, Japan

Location

Fukuiken Saiseikai Hospital /ID# 232988

Fukui-shi, Fukui, 918-8503, Japan

Location

Duplicate_Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 232710

Sapporo, Hokkaido, 003-0003, Japan

Location

Konan Medical Center /ID# 232922

Kobe, Hyōgo, 658-0064, Japan

Location

Mito Kyodo General Hospital /ID# 232990

Mito, Ibaraki, 310-0015, Japan

Location

Atsuchi Neurosurgical Hospital /ID# 232907

Kagoshima, Kagoshima-ken, 892-0842, Japan

Location

Duplicate_Tokai University Hospital /ID# 233071

Isehara-shi, Kanagawa, 259-1193, Japan

Location

Fujitsu Clinic /ID# 232717

Kawasaki-shi, Kanagawa, 211-8588, Japan

Location

Umenotsuji Clinic /ID# 232675

Kochi, Kochi, 780-8011, Japan

Location

Sendai Headache and Neurology Clinic Medical Corporation /ID# 232677

Sendai, Miyagi, 982-0014, Japan

Location

Saitama Medical University Hospital /ID# 233017

Iruma-gun, Saitama, 350-0495, Japan

Location

Saitama Neuropsychiatric Institute /Id# 232711

Saitama-shi, Saitama, 338-8577, Japan

Location

Japanese Red Cross Shizuoka Hospital /ID# 232992

Shizuoka, Shizuoka, 420-0853, Japan

Location

Duplicate_Dokkyo Medical University Hospital /ID# 232995

Shimotsuga-gun, Tochigi, 321-0293, Japan

Location

Niwa Family Clinic /ID# 232713

Chofu-shi, Tokyo, 182-0006, Japan

Location

Duplicate_Tokyo Headache Clinic /ID# 232715

Shibuya-ku, Tokyo, 151-0051, Japan

Location

Keio University Hospital /ID# 233030

Shinjuku-ku, Tokyo, 160-8582, Japan

Location

Duplicate_Nagaseki Headache Clinic /ID# 232719

Kai-shi, Yamanashi, 400-0124, Japan

Location

DOI Internal Medicine-Neurology Clinic /ID# 232722

Hiroshima, 730-0031, Japan

Location

Hiroshima Neurology Clinic /ID# 232720

Hiroshima, 732-0822, Japan

Location

Tanaka Neurosurgical Clinic /ID# 232884

Kagoshima, 892-0844, Japan

Location

Tatsuoka Neurology Clinic /ID# 232912

Kyoto, 600-8811, Japan

Location

Tominaga Hospital /ID# 232909

Osaka, 556-0017, Japan

Location

Shinagawa Strings Clinic /ID# 232908

Tokyo, 108-0075, Japan

Location

Related Links

• Related Info

MeSH Terms

Interventions

atogepant

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: June 18, 2020
• Primary Completion: June 11, 2024
• Study Completion: June 11, 2024
• Last Updated: July 22, 2025
• Results First Posted: July 22, 2025

Record last verified: 2025-07

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: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

JP (24)