Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Episodic Migraine
Episodic Migraine
About this trial
This is an interventional treatment trial for Episodic Migraine focused on measuring Episodic Migraine, Atogepant, QULIPTA, AGN-241689
Eligibility Criteria
Inclusion Criteria: Participants must be between 6 and 17 years of age (inclusive), with a history of episodic migraine. The participant must have completed the lead-in Study M21-201, the pharmacokinetic (PK) substudy in Study M21-201, or completed the 4-week screening/baseline period and screen failed due to not meeting the number of migraine day requirements for the inclusion criteria in Study M21-201, and, in the judgment of the investigator, the participant is an appropriate candidate to be treated with a daily preventive migraine treatment with atogepant (not applicable for de novo migraine participants) Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs). A history of 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. Exclusion Criteria: History of migraine aura with diplopia or impairment of level of consciousness, 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 persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018). Have any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular, or neurologic disease.
Sites / Locations
- Sunwise Clinical Research /ID# 250913
- Alliance for Research - Long Beach /ID# 250911
- Excell Research, Inc /ID# 251611
- Lumos Clinical Research Center /ID# 251608
- Advanced Neurosciences Research, LLC /ID# 250925
- Earle Research /ID# 250908
- Pantheon Clinical Research /ID# 251615
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Atogepant Dose A (12-17 yrs)
Atogepant Dose B (6-11 yrs)
Participant aged 12-17 will receive oral tablets of atogepant Dose A once a day for up to 52 weeks.
Participants aged 6-11 will receive the highest dose of oral tablets of atogepant tested in the lead-in study M21-201.