Recruiting

Phase 3

AtogepantA Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years

Sponsor:

AbbVie

Code:

NCT06810505

Conditions

Chronic Migraine

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Atogepant

Placebo for Atogepant

Study Details

Brief summary:

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.

Conditions

Chronic Migraine

Study ID

NCT06810505

Start date

Feb 13, 2025

Status verified date

Sep, 2026

Completion date

Mar, 2031

Anticipated

Primary completion date

Mar, 2031

Anticipated

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

420 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Atogepant

Participants will receive atogepant once daily for 12 weeks.

placebo comparator: Placebo for Atogepant

Participants will receive placebo for atogepant once daily for 12 weeks.

Interventions

Atogepant

Oral tablet

Placebo for Atogepant

Oral tablet

Primary outcome measure

Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to approximately 16 weeks ]
Change From Baseline in Mean Monthly Migraine Days [ Time Frame: Baseline (Week 0) through Week 12 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742 abbvieclinicaltrials@abbvie.com

Locations

Rehabilitation and Neurological Services /ID# 270782

Recruiting

Huntsville, Alabama, United States, 35805

Preferred Research Partners /ID# 270389

Recruiting

Little Rock, Arkansas, United States, 72211

Advanced Research Center /ID# 270257

Recruiting

Anaheim, California, United States, 92805

Neuro Pain Research Center /ID# 271048

Recruiting

Fresno, California, United States, 93710

Accellacare - Long Beach /ID# 270398

Recruiting

Long Beach, California, United States, 90807

Excell Research /ID# 270258

Recruiting

Oceanside, California, United States, 92056

Lumos Clinical Research Center /ID# 270582

Recruiting

San Jose, California, United States, 95124

Sunwise Clinical Research /ID# 270431

Recruiting

Walnut Creek, California, United States, 94596

Northwest Florida Clinical Research Group, LLC /ID# 270833

Recruiting

Gulf Breeze, Florida, United States, 32561

My Preferred Research /ID# 270312

Recruiting

Miami, Florida, United States, 33155

Encore Medical Research - Weston /ID# 271139

Recruiting

Weston, Florida, United States, 33331

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

Recruiting

Winter Park, Florida, United States, 32789

Deaconess Midtown Hospital /ID# 270572

Recruiting

Evansville, Indiana, United States, 47710

Michigan Headache & Neurological Institute /ID# 270942

Recruiting

Ann Arbor, Michigan, United States, 48104

Proven Endpoints LLC /ID# 270269

Recruiting

Ridgeland, Mississippi, United States, 39157

Cct Research - Papillion Research Center /ID# 270393

Recruiting

Papillion, Nebraska, United States, 68046

Healthy Perspectives - Innovate Mental Health Services /ID# 270847

Recruiting

Nashua, New Hampshire, United States, 03060

Dent Neurologic Institute - Amherst /ID# 270260

Recruiting

Amherst, New York, United States, 14226

The Children's Hospital of Philadelphia /ID# 270842

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Frontier Clinical Research - Scottdale /ID# 270854

Recruiting

Scottdale, Pennsylvania, United States, 15683

Frontier Clinical Research - Smithfield /ID# 270849

Recruiting

Smithfield, Pennsylvania, United States, 15478

Access Clinical Trials Inc /ID# 270280

Recruiting

Nashville, Tennessee, United States, 37203

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

Recruiting

Austin, Texas, United States, 78723-3079

Earle Research /ID# 270424

Recruiting

Houston, Texas, United States, 77058

Clinpoint Trials /ID# 270261

Recruiting

Waxahachie, Texas, United States, 75165

Pantheon Clinical Research /ID# 270259

Recruiting

Bountiful, Utah, United States, 84010

Alpine Research Organization - Clinton /ID# 276527

Recruiting

Clinton, Utah, United States, 84015

Highland Clinical Research /ID# 270281

Recruiting

Salt Lake City, Utah, United States, 84124

Frontier Clinical Research - Kingwood /ID# 271053

Recruiting

Kingwood, West Virginia, United States, 26537

London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 270659

Recruiting

London, Ontario, Canada, N6A 5W9

More Information

Sponsor

AbbVie

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Keywords

Migraine
Chronic Migraine
Atogepant
QULIPTA
AQUIPTA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by AbbVie on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.