[M24-305]Atogepant for the Acute Treatment of Migraine

JRCT ID: jRCT2051240004

Registered date:03/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Migraine
• Date of first enrollment: 03/04/2024
• Target sample size: 1300
• Countries of recruitment: United Kingdom,Japan,Italy,Japan,Spain,Japan,Germany,Japan,Sweden,Japan,Portugal,Japan,Czechia,Japan,Belgium,Japan,Slovakia,Japan,Poland,Japan,Hungary,Japan,Taiwan,Japan,South Korea,Japan,China,Japan
• Study type: Interventional
• Intervention(s): Atogepant 60 mg tablets or matching placebo tablets will be taken for the acute treatment of 4 qualifying migraine attacks during the DB treatment period (up to 16 weeks). After completing the DB period, subjects will treat qualifying migraine attacks with atogepant 60 mg during the OL treatment period until the end of the study at Week 24.

Outcome(s)

Primary Outcome

Percentage of Participants Achieving Pain Freedom at 2 Hours After the Double-Blind (DB) Dose for the First Attack
Pain freedom is defined as a reduction in headache severity from moderate/severe at baseline (predose) to no pain.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

History of migraine (with or without aura) according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) for >= 12 months prior to Visit 1/Screening.
History of 2 to 8 migraine attacks of moderate to severe headache pain in each of the 3 months prior to Visit 1/Screening per investigator judgment.
Migraine onset before the age of 50.
History of migraines lasting between 4 and 72 hours when untreated or treated unsuccessfully and migraine episodes separated by at least 48 hours of headache pain freedom.

Exclude criteria

History of an average of 15 or more headache days per month in the 6 months prior to Visit 1/Screening per the investigator's judgment, or a current diagnosis of chronic migraine as defined by ICHD-3.
Require hospital/emergency room treatment for migraine attacks on 3 or more occasions within 6 months prior to Visit 1/Screening.

Related Information

• Primary Sponsor: Otani Tetsuya
• Secondary ID(s): NCT06241313