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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorAbbVie

About this trial

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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Atogepant

    Drug

    Oral Tablet

Treatment groups

3,000 Participants
are divided into 1 treatment group
Group A: Atogepant1 intervention

Trial outcomes

Primary outcomes

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)

Time frame
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)

Time frame
Up to approximately 16 Weeks
3

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

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

Time frame
Up to approximately 16 Weeks
4

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

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

Time frame
Up to approximately 16 Weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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