A study evaluating oral Atogepant for the Prevention of Migraine in Japanese Participants with Chronic or Episodic Migraine

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225228

Enrollment

170

Registered

2020-06-12

Start date

2020-06-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine without aura, migraine with aura, or chronic migraine

Interventions

investigational material(s) Generic name etc : Atogepant INN of investigational material : - Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administration for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Eligible participants who completed the double-blind treatment period of Study 3101-303-002 without significant protocol deviations and who did not experience an AE that,in the investigator's opinion, may indicate an unacceptable safety risk -Participants must be using a medically acceptable and effective method of birth control during the course of the entire study

Exclusion criteria

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 - Female participant is pregnant, planning to become pregnant during the course of the study, or currently lactating. Women of childbearing potential must have a negative urine pregnancy test at Visit 1 - Hypertension as defined by sitting systolic BP > 160 mm Hg or sitting diastolic BP > 100 mm Hg at Visit 1 -Significant risk of self-harm based on clinical interview and responses on the 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

Design outcomes

Primary

Measure	Time frame
safety Percentage of Participants with at Least 1 Treatment Emergent Adverse Event	—

Secondary

Measure	Time frame
safety -Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator -Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator -Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator -Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales	—

Measure

Time frame

safety -Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator -Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator -Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator -Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales

—

Countries

none

Contacts

Public ContactPatients and HCP Contact

AbbVie G.K.

AbbVie_JPN_info_clingov@abbvie.com+81-120-587-874

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026