Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine (Progress)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080225075

Enrollment

750

Registered

2020-02-17

Start date

2020-02-21

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

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: - At least a 1-year history of CM consistent with a diagnosis according to the ICHD-3, 2018 - Age of the participant at the time of migraine onset = 15 headache days per month in the 3 months prior to Visit 1 in the opinion of the investigator AND - >= 15 headache days during the 4-week screening/baseline period per the electronic diary (eDiary) AND - >= 8 days during the 4-week screening/baseline period that qualify as being a migraine day per the eDiary - Participants must be using a medically acceptable and effective method of birth control during the course of the entire study

Exclusion criteria

Exclusion criteria: - Has a history of migraine, accompanied by diplopia or decreased level of consciousness, or retinal migraine - Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy - History of an inadequate response to > 4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine - Woman 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 and Visit 2

Design outcomes

Primary

Measure	Time frame
efficacy Change from baseline in mean monthly migraine days across the treatment period	—

Secondary

Measure	Time frame
efficacy - Change from baseline in mean monthly headache days across the 12-week treatment period - Change from baseline in mean monthly acute medication use days across the 12-week treatment period - Proportion of participants with at least a 50% reduction in mean monthly migraine days across the 12-week treatment period - Change from baseline in MSQ v2.1 Role Function-Restrictive domain score at Week 12 - Change from baseline in mean AIM-D monthly functioning and activity impairment score across the 12-week treatment period	—

Measure

Time frame

efficacy - Change from baseline in mean monthly headache days across the 12-week treatment period - Change from baseline in mean monthly acute medication use days across the 12-week treatment period - Proportion of participants with at least a 50% reduction in mean monthly migraine days across the 12-week treatment period - Change from baseline in MSQ v2.1 Role Function-Restrictive domain score at Week 12 - Change from baseline in mean AIM-D monthly functioning and activity impairment score across the 12-week treatment period

—

Countries

Asia, Europe, North America, Oceania, Russian Federation

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