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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

RecruitingPhase 3Ages 12 Years - 17 YearsAllAbbVie
NCT06810505 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 light and sound, or other symptoms. The goals of the study are to evaluate adverse events and how well treatment of atogepant works compared to placebo (looks like the study treatment but contains no medicine) in preventing chronic migraine in participants between 12 and 17 years of age. Atogepant is a medicine currently approved in the United States and Europe for the preventive treatment of migraine in adult patients with migraine and is being studied for the preventative treatment of chronic migraine in participants between the ages of 12 and 17 years. Participants will be randomly assigned to one of the 2 groups to be treated with either atogepant or placebo. This study is double-blind

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📋 Eligibility rules (as published)
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.
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What it tests

  • Atogepant
  • Placebo for Atogepant
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Where

66 sites
Rehabilitation and Neurological Services /ID# 270782
Huntsville, United States
Preferred Research Partners - Fayetteville /ID# 270419
Fayetteville, United States
Preferred Research Partners /ID# 270389
Little Rock, United States
Advanced Research Center /ID# 270257
Anaheim, United States
Neuro Pain Research Center /ID# 271048
Fresno, United States
Alliance for Research Alliance for Wellness /ID# 270398
Long Beach, United States
Excell Research /ID# 270258
Oceanside, United States
Lumos Clinical Research Center /ID# 270582
San Jose, United States

…and 58 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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