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
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: 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 and per investigator judgment is appropriate to receive preventive treatment for migraine. 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 required in-hospital (excluding emergency department visits) treatment for migraine 3 or more times in the 6 months prior to Visit 1.
Sites / Locations
- Rehabilitation & Neurological Services /ID# 248517Recruiting
- Preferred Research Partners /ID# 249729Recruiting
- Advanced Research Center /ID# 251381Recruiting
- Sunwise Clinical Research /ID# 248529Recruiting
- Alliance for Research - Long Beach /ID# 248521Recruiting
- Excell Research, Inc /ID# 247532Recruiting
- Lumos Clinical Research Center /ID# 249731Recruiting
- Advanced Neurosciences Research, LLC /ID# 247592Recruiting
- Northwest Florida Clinical Research Group, LLC /ID# 251382Recruiting
- Advanced Research Institute of Miami /ID# 248539Recruiting
- My Preferred Research LLC /ID# 249720Recruiting
- Asclepes Research Centers - Spring Hill /ID# 248525Recruiting
- Coastal Georgia Child Neurology /ID# 249733Recruiting
- Deaconess Clinic - Gateway Health Center /ID# 247589Recruiting
- College Park Family Care Center Overland Park /ID# 249734Recruiting
- Michigan Headache & Neurological Institute (MHNI) /ID# 247468Recruiting
- Cognitive Clinical Trials (CCT) - Papillion /ID# 248536Recruiting
- Goryeb Children's Hospital /ID# 249724Recruiting
- Dent Neurosciences Research Center, Inc. /ID# 248534Recruiting
- Headache Wellness Center /ID# 251018Recruiting
- Patient Priority Clinical Sites, LLC /ID# 247535Recruiting
- CincyScience /ID# 249726Recruiting
- Lynn Health Science Institute (LHSI) /ID# 247600Recruiting
- Access Clinical Trials, Inc. /ID# 248532Recruiting
- FutureSearch Trials of Neurology /ID# 247470Recruiting
- 3A Research - East El Paso /ID# 248516Recruiting
- Earle Research /ID# 248501Recruiting
- Family Psychiatry of The Woodlands /ID# 249727Recruiting
- ClinPoint Trials /ID# 248540Recruiting
- Pantheon Clinical Research /ID# 251601Recruiting
- Highland Clinical Research /ID# 247590Recruiting
- Office of Maria Ona /ID# 249738Recruiting
- Core Clinical Research /ID# 249721Recruiting
- Puerto Rico Health Institute /ID# 249741Recruiting
- Caribbean Medical Research Center /ID# 251634Recruiting
Arms of the Study
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Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Open-Label PK Substudy: Atogepant Dose A (6-11 yrs)
Open-Label PK Substudy: Atogepant Dose B (6-11 yrs)
Double-Blind Treatment Period: High Dose Atogepant (12-17 yrs)
Double-Blind Treatment Period: Placebo (12-17 yrs)
Double-Blind Treatment Period: Low Dose Atogepant (12-17 yrs)
Double-Blind Treatment Period: High Dose Atogepant (6-11 yrs)
Double-Blind Treatment Period: Placebo (6-11 yrs)
Double-Blind Treatment Period: Low Dose Atogepant (6-11 yrs)
Participants aged 6 to 11 will receive oral tablets of atogepant Dose A to determine appropriate dose for the 6-11 year old group in double-blind treatment period.
Participants aged 6 to 11 will receive oral tablets of atogepant Dose B to determine appropriate dose for the 6-11 year old group in double-blind treatment period.
Participants aged 12 to 17 will receive oral tablets of high dose atogepant once a day for 12 weeks.
Participants aged 12 to 17 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.
Participants aged 12 to 17 will receive oral tablets of low dose atogepant once a day for 12 weeks.
Participants aged 6-11 will receive oral tablets of high dose atogepant once a day for 12 weeks.
Participants aged 6 to 11 will receive oral tablets of placebo-matching atogepant once a day for 12 weeks.
Participants aged 6-11 will receive oral tablets of low dose atogepant once a day for 12 weeks.