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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

AbbVie · NCT06810505

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 12–17 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
420
US sites recruiting
29
Study start
February 13, 2025
Record last updated
October 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Atogepant; Placebo for Atogepant

Conditions: Chronic Migraine

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Rehabilitation and Neurological Services /ID# 270782

    Huntsville, AL 35805

  • Preferred Research Partners /ID# 270389

    Little Rock, AR 72211

  • Advanced Research Center /ID# 270257

    Anaheim, CA 92805

  • Neuro Pain Research Center /ID# 271048

    Fresno, CA 93710

  • Alliance for Research Alliance for Wellness /ID# 270398

    Long Beach, CA 90807

  • Excell Research /ID# 270258

    Oceanside, CA 92056

  • Lumos Clinical Research Center /ID# 270582

    San Jose, CA 95124

  • Sunwise Clinical Research /ID# 270431

    Walnut Creek, CA 94596

  • Northwest Florida Clinical Research Group, LLC /ID# 270833

    Gulf Breeze, FL 32561

  • My Preferred Research /ID# 270312

    Miami, FL 33155

  • Encore Medical Research - Weston /ID# 271139

    Weston, FL 33331

  • Pediatric Neurology & Epilepsy Center Of Central Florida - Winter Park /ID# 275263

    Winter Park, FL 32789

  • Deaconess Midtown Hospital /ID# 270572

    Evansville, IN 47710

  • Michigan Headache & Neurological Institute /ID# 270942

    Ann Arbor, MI 48104

  • Proven Endpoints LLC /ID# 270269

    Ridgeland, MS 39157

  • Cct Research - Papillion Research Center /ID# 270393

    Papillion, NE 68046

  • Healthy Perspectives - Innovate Mental Health Services /ID# 270847

    Nashua, NH 03060

  • Dent Neurologic Institute - Amherst /ID# 270260

    Amherst, NY 14226

  • The Children's Hospital of Philadelphia /ID# 270842

    Philadelphia, PA 19104

  • Frontier Clinical Research - Scottdale /ID# 270854

    Scottdale, PA 15683

  • Frontier Clinical Research - Smithfield /ID# 270849

    Smithfield, PA 15478

  • Access Clinical Trials Inc /ID# 270280

    Nashville, TN 37203

  • UT Health Austin at Dell Childrens Neurology Clinic /ID# 270577

    Austin, TX 78723-3079

  • Earle Research /ID# 270424

    Houston, TX 77058

  • Clinpoint Trials /ID# 270261

    Waxahachie, TX 75165

  • Pantheon Clinical Research /ID# 270259

    Bountiful, UT 84010

  • Alpine Research Organization - Clinton /ID# 276527

    Clinton, UT 84015

  • Highland Clinical Research /ID# 270281

    Salt Lake City, UT 84124

  • Frontier Clinical Research - Kingwood /ID# 271053

    Kingwood, WV 26537

Study contacts (from the official record)

  • ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
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A Study of Oral Atogepant Tablets to Assess Adverse Events and… (NCT06810505) | Bored Studies