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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Chronic Migraine

In brief

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.

Key facts

Study ID

NCT06810505

Run by

AbbVie

People needed

420

Starts

2025-02-13

Expected to finish

2031-03-01

Last updated by the study team

2026-07-14

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Clinically significant hypertension per investigator's judgment.
• History of any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.

Where it is running

• Earle Research /ID# 270424 — Houston, Texas, United States (enrolling)
• Preferred Research Partners /ID# 270389 — Little Rock, Arkansas, United States (enrolling)
• Advanced Research Center /ID# 270257 — Anaheim, California, United States (enrolling)
• Rehabilitation and Neurological Services /ID# 270782 — Huntsville, Alabama, United States (enrolling)
• Accellacare - Long Beach /ID# 270398 — Long Beach, California, United States (enrolling)
• Excell Research /ID# 270258 — Oceanside, California, United States (enrolling)
• Lumos Clinical Research Center /ID# 270582 — San Jose, California, United States (enrolling)
• Sunwise Clinical Research /ID# 270431 — Walnut Creek, California, United States (enrolling)
• Northwest Florida Clinical Research Group, LLC /ID# 270833 — Gulf Breeze, Florida, United States (enrolling)
• Neuro Pain Research Center /ID# 271048 — Fresno, California, United States (enrolling)
• My Preferred Research /ID# 270312 — Miami, Florida, United States (enrolling)
• Encore Medical Research - Weston /ID# 271139 — Weston, Florida, United States (enrolling)
• Pediatric Neurology & Epilepsy Center Of Central Florida - Winter Park /ID# 275263 — Winter Park, Florida, United States (enrolling)
• Deaconess Midtown Hospital /ID# 270572 — Evansville, Indiana, United States (enrolling)
• Michigan Headache & Neurological Institute /ID# 270942 — Ann Arbor, Michigan, United States (enrolling)
• Proven Endpoints LLC /ID# 270269 — Ridgeland, Mississippi, United States (enrolling)
• Cct Research - Papillion Research Center /ID# 270393 — Papillion, Nebraska, United States (enrolling)
• Healthy Perspectives - Innovate Mental Health Services /ID# 270847 — Nashua, New Hampshire, United States (enrolling)
• Dent Neurologic Institute - Amherst /ID# 270260 — Amherst, New York, United States (enrolling)
• Headache Wellness Center /ID# 270568 — Greensboro, North Carolina, United States (enrolling)
• Frontier Clinical Research - Scottdale /ID# 270854 — Scottdale, Pennsylvania, United States (enrolling)
• Frontier Clinical Research - Smithfield /ID# 270849 — Smithfield, Pennsylvania, United States (enrolling)
• Access Clinical Trials Inc /ID# 270280 — Nashville, Tennessee, United States (enrolling)
• UT Health Austin at Dell Childrens Neurology Clinic /ID# 270577 — Austin, Texas, United States (enrolling)
• Clinpoint Trials /ID# 270261 — Waxahachie, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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