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RECRUITINGPhase 3INTERVENTIONAL

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

A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Chronic Migraine in Pediatric Subjects 12 to 17 Years of Age

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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-blinded, which means that neither the patients nor the study doctors know who is given which study treatment. Approximately 420 participants 12 to 17 years of age with chronic migraine will be enrolled at approximately 70 sites across the world. Participants will receive oral tablets of atogepant or placebo once daily for 12 weeks and will be followed for 4 weeks. Participants will attend regular visits during the study at a hospital or clinic and the effects of treatment will be checked by completion of a daily diary, medical assessments, blood tests, checking for side effects, and completing questionnaires.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - Clinically significant hypertension per investigator's judgment. - History of any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Atogepant

Oral tablet

DRUG

Placebo for Atogepant

Oral tablet

Locations (20)

Rehabilitation & Neurological Services /ID# 270782
Huntsville, Alabama, United States
Preferred Research Partner, Inc /ID# 270389
Little Rock, Arkansas, United States
Preferred Research Partners /ID# 270419
Little Rock, Arkansas, United States
Advanced Research Center /ID# 270257
Anaheim, California, United States
Neuro Pain Research Center /ID# 271048
Fresno, California, United States
Accellacare - Long Beach /ID# 270398
Long Beach, California, United States
Excell Research /ID# 270258
Oceanside, California, United States
Lumos Clinical Research Center /ID# 270582
San Jose, California, United States
Sunwise Clinical Research /ID# 270431
Walnut Creek, California, United States
Northwest Florida Clinical Research Group, LLC /ID# 270833
Gulf Breeze, Florida, United States
Auzmer Research /ID# 271158
Lakeland, Florida, United States
My Preferred Research /ID# 270312
Miami, Florida, United States
Encore Medical Research - Weston /ID# 271139
Weston, Florida, United States
Pediatric Neurology & Epilepsy Center Of Central Florida - Winter Park /ID# 275263
Winter Park, Florida, United States
Deaconess Midtown Hospital /ID# 270572
Evansville, Indiana, United States
Michigan Headache & Neurological Institute /ID# 270942
Ann Arbor, Michigan, United States
Proven Endpoints LLC /ID# 270269
Ridgeland, Mississippi, United States
Cct Research - Papillion Research Center /ID# 270393
Papillion, Nebraska, United States
Healthy Perspectives - Innovate Mental Health Services /ID# 270847
Nashua, New Hampshire, United States
Dent Neurologic Institute - Amherst /ID# 270260
Amherst, New York, United States