Status:
RECRUITING
A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine
Lead Sponsor:
AbbVie
Conditions:
Episodic Migraine
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
A migraine is a 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 light and sound, or other sy...
Eligibility Criteria
Inclusion
- Weight is \>= 20 kg (44 lbs) and \< 135 kg (298 lbs).
- History of episodic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD) -3 (2018) for at least 6 months.
- Participant has to have 4 to 14 migraine days and \< 15 headache days in the 28-day baseline period per eDiary.
- To be eligible for the PK substudy, participants must be 6 to 11 years of age (inclusive), with a history of migraine (consistent with a diagnosis according to the ICHD-3 \[2018\]) and per investigator judgment is appropriate to receive preventive treatment for migraine.
Exclusion
- History of migraine brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018).
- Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018).
- Have a current diagnosis of new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT05711394
Start Date
May 1 2023
End Date
May 1 2028
Last Update
February 10 2026
Active Locations (98)
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1
Rehabilitation & Neurological Services /ID# 248517
Huntsville, Alabama, United States, 35805-4046
2
The Center for Clinical Trials - Saraland /ID# 271604
Saraland, Alabama, United States, 36571
3
Preferred Research Partners /ID# 249729
Little Rock, Arkansas, United States, 72211
4
Preferred Research Partners /ID# 270406
Little Rock, Arkansas, United States, 72211