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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

RecruitingPhase 3Ages 6 Years - 17 YearsAllAbbVie
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In plain words

What the trial is, and whether it could suit you

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 pharm

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 (consistent with a diagnosis according to the ICHD-3 \[2018\]) and per investigator judgment is appropriate to receive preventive treatment for migraine. Exclusion Criteria: * 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).
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What it tests

  • Atogepant
  • Placebo-Matching Atogepant
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Where

98 sites
Rehabilitation & Neurological Services /ID# 248517
Huntsville, United States
The Center for Clinical Trials - Saraland /ID# 271604
Saraland, United States
Preferred Research Partners /ID# 249729
Little Rock, United States
Preferred Research Partners /ID# 270406
Little Rock, United States
Advanced Research Center /ID# 251381
Anaheim, United States
Alliance for Research Alliance for Wellness /ID# 248521
Long Beach, United States
Excell Research, Inc /ID# 247532
Oceanside, United States
Lumos Clinical Research Center /ID# 249731
San Jose, United States

โ€ฆand 90 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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