JRCT ID: jRCT2051240004
Registered date:03/04/2024
[M24-305]Atogepant for the Acute Treatment of Migraine
Basic Information
Recruitment status | Recruiting |
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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. |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | NCT06241313 |
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 |
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 |
AbbVie_JPN_info_clingov@abbvie.com | |
Affiliation | AbbVie G.K, |