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Chronic MigrainePhase 3JPN ATO OLENCT04437433

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

A Phase 3 study testing Atogepant 60 mg in people with Chronic Migraine and Episodic Migraine, run by AbbVie at 24 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Migraine, Episodic Migraine
What is being tested?
Atogepant 60 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
186 participants
Where
24 sitesJapan
Study dates
18 Jun 2020to 11 Jun 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 12Show fewer
  • 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.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

Japan24 sites

  • Niwa Family Clinic /ID# 232713

    Chofu-shi, Tokyo, 182-0006

  • Fukuiken Saiseikai Hospital /ID# 232988

    Fukui-shi, Fukui, 918-8503

  • DOI Internal Medicine-Neurology Clinic /ID# 232722

    Hiroshima, 730-0031

  • Hiroshima Neurology Clinic /ID# 232720

    Hiroshima, 732-0822

  • Saitama Medical University Hospital /ID# 233017

    Iruma-gun, Saitama, 350-0495

  • Duplicate_Tokai University Hospital /ID# 233071

    Isehara-shi, Kanagawa, 259-1193

  • Atsuchi Neurosurgical Hospital /ID# 232907

    Kagoshima, Kagoshima-ken, 892-0842

  • Tanaka Neurosurgical Clinic /ID# 232884

    Kagoshima, 892-0844

  • Duplicate_Nagaseki Headache Clinic /ID# 232719

    Kai-shi, Yamanashi, 400-0124

  • Fujitsu Clinic /ID# 232717

    Kawasaki-shi, Kanagawa, 211-8588

  • Konan Medical Center /ID# 232922

    Kobe, Hyōgo, 658-0064

  • Umenotsuji Clinic /ID# 232675

    Kochi, Kochi, 780-8011

  • Tatsuoka Neurology Clinic /ID# 232912

    Kyoto, 600-8811

  • Takanoko Hospital /ID# 232723

    Matsuyama, Ehime, 790-0925

  • Mito Kyodo General Hospital /ID# 232990

    Mito, Ibaraki, 310-0015

  • Tominaga Hospital /ID# 232909

    Osaka, 556-0017

  • Saitama Neuropsychiatric Institute /Id# 232711

    Saitama-shi, Saitama, 338-8577

  • Duplicate_Higashi Sapporo Neurology and Neurosurgery Clinic /ID# 232710

    Sapporo, Hokkaido, 003-0003

  • Sendai Headache and Neurology Clinic Medical Corporation /ID# 232677

    Sendai, Miyagi, 982-0014

  • Duplicate_Tokyo Headache Clinic /ID# 232715

    Shibuya-ku, Tokyo, 151-0051

  • Duplicate_Dokkyo Medical University Hospital /ID# 232995

    Shimotsuga-gun, Tochigi, 321-0293

  • Keio University Hospital /ID# 233030

    Shinjuku-ku, Tokyo, 160-8582

  • Japanese Red Cross Shizuoka Hospital /ID# 232992

    Shizuoka, Shizuoka, 420-0853

  • Shinagawa Strings Clinic /ID# 232908

    Tokyo, 108-0075

Other trials in Japan

About this study

Official title: A Phase 3, Multicenter, Open-Label 52-Week Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine

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).

Read the 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.

Being tested
Atogepant 60 mg
Keywords
Chronic Migraine, Episodic Migraine, Atogepant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Atogepant 60 mgDrug

    Tablets containing 60 mg atogepant

Study groups in NCT04437433
Study groupRoleWhat they receive
Atogepant 60 mg Chronic MigraineExperimentalParticipants 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.
Receives: Drug: Atogepant 60 mg
Atogepant 60 mg Episodic MigraineExperimentalParticipants 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.
Receives: Drug: Atogepant 60 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)

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

    Clinical laboratory test values are considered PCS if they meet either the lower-limit or higher-limit PCS criteria defined in the categories below. The percentage of participants with PCS laboratory values are summarized for hematology, chemistry, and urinalysis.

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

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

    12-lead ECGs were performed at select study visits.

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

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

    Potentially Clinically Significant post-Baseline vital sign values are summarized for categories: systolic and diastolic blood pressures [sitting and standing], pulse rate [sitting and standing], and weight.

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

  4. 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

    The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior).

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

  5. 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

    The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior).

    Measured: Up to 4 weeks following the last dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2020
  2. Study start18 Jun 2020
  3. Primary completion11 Jun 2024
  4. Study completion11 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04437433
Sponsor's protocol ID
3101-306-002
Acronym
JPN ATO OLE
Status last verified
Jul 2025
First submitted
16 Jun 2020
Last updated
22 Jul 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Publications

  • Matsumori Y, Nagy K, Takahashi A, Tanaka S, Takeshima T, Forero G, Bao J, Guo H, Ahmadyar G, de Abreu Ferreira R, Yamamoto T. Atogepant for the Preventive Treatment of Migraine in Japanese Participants: A Phase 3, Open-Label, 52-Week Extension Study. Neurol Ther. 2026 Jun;15(3):1137-1154. doi: 10.1007/s40120-026-00905-3. Epub 2026 Mar 11.

    PubMed 41814051

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atogepant 60 mg in people with Chronic Migraine and Episodic Migraine, run by AbbVie at 24 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) (time frame: From first dose of study drug until 4 weeks following the last dose of study drug (up to 56 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04437433, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.

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