Status:
RECRUITING
A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years
Lead Sponsor:
AbbVie
Conditions:
Chronic Migraine
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
Brief Summary
Migraine is a disease that most often causes moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to...
Eligibility Criteria
Inclusion Criteria:
-
History of chronic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) (2018) for at least 6 months as of Visit 1.
-
During the last 28 days of the screening/baseline period, and as per eDiary:
- Participant must have completed the eDiary for a minimum of 20 out of 28 days.
- Participant has >= 15 headache days.
- Participant has >= 8 migraine days.
Exclusion Criteria:
- Clinically significant hypertension per investigator's judgment.
- History of any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.
Key Trial Info
Start Date :
February 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2031
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT06810505
Start Date
February 13 2025
End Date
March 1 2031
Last Update
April 14 2026
Active Locations (61)
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1
Rehabilitation & Neurological Services /ID# 270782
Huntsville, Alabama, United States, 35805
2
Preferred Research Partner, Inc /ID# 270389
Little Rock, Arkansas, United States, 72211
3
Preferred Research Partners /ID# 270419
Little Rock, Arkansas, United States, 72211
4
Advanced Research Center /ID# 270257
Anaheim, California, United States, 92805