Condition: Episodic Migraine · Sponsor: AbbVie
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 symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17. Atogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in participants between the ages of 6 and 11 will be determined after the PK substudy is complete. Around 450 participants will be enrolled in approximately 100 sites worldwide. Placebo, low…
This description comes directly from the study's public registry record.
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| Rehabilitation & Neurological Services /ID# 248517 | Huntsville, Alabama, United States | Recruiting |
| The Center for Clinical Trials - Saraland /ID# 271604 | Saraland, Alabama, United States | Recruiting |
| Preferred Research Partners /ID# 249729 | Little Rock, Arkansas, United States | Recruiting |
| Preferred Research Partners /ID# 270406 | Little Rock, Arkansas, United States | Completed |
| Advanced Research Center /ID# 251381 | Anaheim, California, United States | Recruiting |
| Alliance for Research Alliance for Wellness /ID# 248521 | Long Beach, California, United States | Recruiting |
| Excell Research, Inc /ID# 247532 | Oceanside, California, United States | Recruiting |
| Lumos Clinical Research Center /ID# 249731 | San Jose, California, United States | Recruiting |
| Sunwise Clinical Research /ID# 248529 | Walnut Creek, California, United States | Recruiting |
| Advanced Neurosciences Research, LLC /ID# 247592 | Fort Collins, Colorado, United States | Completed |
| Northwest Florida Clinical Research Group, LLC /ID# 251382 | Gulf Breeze, Florida, United States | Recruiting |
| Advanced Research Institute of Miami /ID# 248539 | Homestead, Florida, United States | Completed |
+ 86 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05711394