NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2051240004

Registered date:03/04/2024

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedMigraine
Date of first enrollment03/04/2024
Target sample size1300
Countries of recruitmentUnited 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 typeInterventional
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 OutcomePercentage 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.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 75age old
GenderBoth
Include criteriaHistory 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 criteriaHistory 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

Contact

Public contact
Name Contact for Patients and HCP
Address 3-1-21 Shibaura, Minato-ku, Tokyo Tokyo Japan 108-0023
Telephone +81-120-587-874
E-mail AbbVie_JPN_info_clingov@abbvie.com
Affiliation AbbVie G.K,
Scientific contact
Name Tetsuya Otani
Address 3-1-21 Shibaura, Minato-ku, Tokyo Tokyo Japan 108-0023
Telephone +81-120-587-874
E-mail AbbVie_JPN_info_clingov@abbvie.com
Affiliation AbbVie G.K,