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Chronic MigraineAtogepant PMSSNCT06603558

Post-Marketing Study to Assess the Safety and Effectiveness of Oral Atogepant in Korean Adult Participants for the Prevention of Chronic or Episodic Migraine

An observational study of Chronic Migraine and Episodic Migraine, run by AbbVie at 36 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. The study will assess the safety and effectiveness of atogepant for the preventive treatment of migraine in Korean adult patients with chronic migraine or episodic… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Chronic Migraine, Episodic Migraine, Migraine
What is being tested?
Atogepant
Type of treatment
Pill or oral medicine
How many people
3,000 participants
Where
36 sitesSouth Korea
Study dates
24 Sep 2024to May 2029
Phase
Observational
Are there results?
Not yet: the study is under way

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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult participants who have been prescribed atogepant for preventive treatment migraine according to the latest approved local label in routine clinical practice.

Who may be able to join

  • Participants with migraine suitable for the treatment with atogepant according to the latest approved local label.
  • Participants prescribed atogepant in accordance with the approved local label.

Who cannot join

  • Participants with any contraindication to atogepant as listed on the latest approved local label.
  • Participants currently participating in another clinical research except observational study.

Trial locations and contacts

36 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Celine Im contact

+82-10-2230-3629

celine.im@abbvie.com

36 sites in 1 country

South Korea36 sites, 36 recruiting

  • Korea University Ansan Hospital /ID# 284725

    Ansan-si, Gyeonggido, 15355

    Recruiting

  • On Hospital /ID# 285157

    Busan, Busan Gwang Yeogsi, 47261

    Recruiting

  • Ryu Sang Hyo Neurosurgery Clinic /ID# 284804

    Busan, Busan Gwang Yeogsi, 48496

    Recruiting

  • Dong-A University Medical Center /ID# 275321

    Busan, Busan Gwang Yeogsi, 49201

    Recruiting

  • Changwon Fatima Hospital /ID# 284572

    Changwon-si, Gyeongsangnam-do, 51394

    Recruiting

  • Daegu Catholic University Medical Center /ID# 284728

    Daegu, Gyeongsangbuk-do, 42472

    Recruiting

  • Keimyung University Dongsan Hospital /ID# 284727

    Daegu, Gyeongsangbuk-do, 42601

    Recruiting

  • Chungnam National University Hospital /ID# 284724

    Daejeon, Daejeon Gwang Yeogsi, 35015

    Recruiting

  • Chuncheon Sacred Heart Hospital /ID# 275315

    Gangwon-do, Gang Weondo, 24253

    Recruiting

  • Inje University - Ilsan Paik Hospital /ID# 280738

    Goyang, Gyeonggido, 10380

    Recruiting

  • National Health Insurance Corporation Ilsan Hospital /ID# 285128

    Goyang-si, Gyeonggido, 10444

    Recruiting

  • Chonnam National University Hospital /ID# 275318

    Gwangju, Gwangju Gwang Yeogsi, 61469

    Recruiting

  • Hallym University Dongtan Sacred Heart Hospital /ID# 273581

    Hwaseong, Gyeonggido, 18450

    Recruiting

  • Hallym University Dongtan Sacred Heart Hospital /ID# 280737

    Hwaseong, Gyeonggido, 18450

    Recruiting

  • Teunteun Hospital /ID# 284730

    Hwaseong-si, Gyeonggido, 18379

    Recruiting

  • Life Neurology Clinic /ID# 284729

    Hwaseong-si, Gyeonggido, 18478

    Recruiting

  • Wonkwang University Hospital /ID# 284567

    Iksan, Jeonrabugdo, 54538

    Recruiting

  • Gachon University Gil Medical Center /ID# 284571

    Incheon, Gyeonggido, 21565

    Recruiting

  • The Catholic University of Korea, Incheon St. Mary's Hospital /ID# 284568

    Incheon, Incheon Gwang Yeogsi, 21431

    Recruiting

  • Inha University Hospital /ID# 275320

    Incheon, Incheon Gwang Yeogsi, 21565

    Recruiting

  • Jeonbuk National University Hospital /ID# 273583

    Jeonju, Jeonrabugdo, 54907

    Recruiting

  • Seoul National University Bundang Hospital /ID# 284508

    Seongnam-si, Gyeonggido, 13620

    Recruiting

  • Nowon Eulji Medical Center, Eulji University /ID# 275316

    Seoul, Seoul Teugbyeolsi, 01830

    Recruiting

  • Korea University Anam Hospital /ID# 284726

    Seoul, Seoul Teugbyeolsi, 02841

    Recruiting

  • Seoul National University Hospital /ID# 271892

    Seoul, Seoul Teugbyeolsi, 03080

    Recruiting

  • Seoul National University Hospital /ID# 272638

    Seoul, Seoul Teugbyeolsi, 03080

    Recruiting

  • Kangbuk Samsung Hospital /ID# 271893

    Seoul, Seoul Teugbyeolsi, 03181

    Recruiting

  • Yonsei University Health System Severance Hospital /ID# 272639

    Seoul, Seoul Teugbyeolsi, 03722

    Recruiting

  • Samsung Medical Center /ID# 272640

    Seoul, Seoul Teugbyeolsi, 06351

    Recruiting

  • Ewha Womans University Medical Centre /ID# 275317

    Seoul, Seoul Teugbyeolsi, 07985

    Recruiting

  • Korea University Guro Hospital /ID# 284569

    Seoul, Seoul Teugbyeolsi, 08308

    Recruiting

  • Hallym University Kangdong Sacred Heart Hospital /ID# 284573

    Seoul, 05355

    Recruiting

  • Ajou University Hospital - Suwon-si /ID# 284574

    Suwon, Gyeonggido, 16499

    Recruiting

  • Hwahong Hospital /ID# 284803

    Suwon, Gyeonggido, 16630

    Recruiting

  • Uijeongbu Eulji Medical Center - Eulji University /ID# 284855

    Uijeongbu-si, Gyeonggido, 11759

    Recruiting

  • Yongin Severance Hospital /ID# 284570

    Yongin-si, Gyeonggido, 16995

    Recruiting

Other trials in South Korea

About this study

Official title: Post-marketing Surveillance Study to Evaluate the Safety and Effectiveness of Atogepant for the Prevention of Migraine in Korean Adult Patients

Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. The study will assess the safety and effectiveness of atogepant for the preventive treatment of migraine in Korean adult patients with chronic migraine or episodic migraine under routine clinical practice.

Atogepant is an approved drug for preventive treatment of migraine in adults. Approximately 3000 adult participants who are prescribed atogepant by their doctors will be enrolled in this study in Korea.

Read more

Participants will receive atogepant oral tablets as prescribed by their physician. Participants will be followed for up to week 12.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Being tested
Atogepant
Keywords
Chronic Migraine, Episodic Migraine, Migraine, Atogepant, Qulipta, Aquipta
Medical subject headings
Migraine Disorders

What participants receive

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

  • AtogepantDrug

    Also called Qulipta, Aquipta

    Oral Tablet

Study groups in NCT06603558
Study groupRoleWhat they receive
AtogepantParticipants will receive atogepant as prescribed by their physician according to the local label.
Receives: Drug: Atogepant

What is being measured

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

  1. Percentage (%) of participants who reported serious adverse event (SAE)/drug reaction (SADR)

    Percentage (%) of participants who reported serious adverse event (SAE)/drug reaction (SADR)

    Measured: Up to approximately 16 Weeks

  2. Percentage (%) of participants who reported unexpected (not reflected in the latest approved label) adverse event (AE)/drug reaction (ADR)

    Percentage (%) of participants who reported unexpected (not reflected in the latest approved label) adverse event (AE)/drug reaction (ADR)

    Measured: Up to approximately 16 Weeks

  3. Percentage (%) of participants who reported known (labeled) ADR

    Percentage (%) of participants who reported known (labeled) ADR

    Measured: Up to approximately 16 Weeks

  4. Percentage (%) of participants who reported non-serious AE/ADR

    Percentage (%) of participants who reported non-serious AE/ADR

    Measured: Up to approximately 16 Weeks

  5. Percentage (%) of participants who reported the events related to important potential risks and missing information defined in the Risk Management Plan (RMP)

    Percentage (%) of participants who reported the events related to important potential risks and missing information defined in the RMP

    Measured: Up to approximately 16 Weeks

  6. Percentage (%) of participants with AE: overall summary

    Percentage (%) of participants with AE: overall summary

    Measured: Up to approximately 16 Weeks

  7. Percentage (%) of participants with common (>=5%) AE

    Percentage (%) of participants with common (>=5%) AE

    Measured: Up to approximately 16 Weeks

  8. Percentage (%) of participants with AE leading to treatment discontinuation

    Percentage (%) of participants with AE leading to treatment discontinuation

    Measured: Up to approximately 16 Weeks

  9. Percentage (%) of participants who reported treatment-related AE per the investigator causality assessment

    Percentage (%) of participants who reported treatment-related AE per the investigator causality assessment

    Measured: Up to approximately 16 Weeks

  10. Percentage (%) of participants who reported treatment-related serious AE per the investigator causality assessment

    Percentage (%) of participants who reported treatment-related serious AE per the investigator causality assessment

    Measured: Up to approximately 16 Weeks

Timeline

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

  1. First posted19 Sep 2024
  2. Study start24 Sep 2024
  3. Primary completionMay 2029 (estimated)
  4. Study completionMay 2029 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06603558
Sponsor's protocol ID
P24-480
Acronym
Atogepant PMSS
Status last verified
Jul 2026
First submitted
17 Sep 2024
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Migraine and Episodic Migraine, run by AbbVie at 36 sites in South Korea.

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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in South Korea. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Celine Im (+82-10-2230-3629, celine.im@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage (%) of participants who reported serious adverse event (SAE)/drug reaction (SADR) (time frame: Up to approximately 16 Weeks). The study lists 10 primary outcomes in all. 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 NCT06603558.

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 2026.

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