Status:
RECRUITING
Study of Oral Atogepant Tablets to Assess Safety and Efficacy in Adult Participants With Migraine
Lead Sponsor:
AbbVie
Conditions:
Migraine
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
A migraine attack is a moderate or severe headache that usually occurs on one side of the head and is often accompanied by throbbing, sensitivity to light, sensitivity to sound, nausea, or other sympt...
Eligibility Criteria
Inclusion 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.
Exclusion 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.
Key Trial Info
Start Date :
March 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT06241313
Start Date
March 25 2024
End Date
November 1 2026
Last Update
April 14 2026
Active Locations (149)
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1
Universitair Ziekenhuis Antwerpen /ID# 257582
Edegem, Antwerpen, Belgium, 2650
2
Universitair Ziekenhuis Brussel /ID# 257584
Jette, Brussels Capital, Belgium, 1090
3
Cabinet Prive Dr Sava /ID# 257581
Saint-Nicolas, Liege, Belgium, 4420
4
Jessa Ziekenhuis /ID# 257578
Hasselt, Limburg, Belgium, 3500