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NCT06810505 | RECRUITING | Chronic Migraine

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
Sponsor:

AbbVie

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.

Condition or disease

Chronic Migraine

Intervention/treatment

Atogepant

Placebo for Atogepant

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 420 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2025-02-13
Estimated Primary Completion Date : 2031-03
Estimated Study Completion Date : 2031-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 12 Years to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
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

Location Details

NCT06810505

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, alabama

Rehabilitation & Neurological Services /ID# 270782

Huntsville, alabama, United States, 35805

RECRUITING

United States, Arkansas

Preferred Research Partner, Inc /ID# 270389

Little Rock, arkansas, United States, 72211

COMPLETED

United States, Arkansas

Preferred Research Partners /ID# 270419

Little Rock, arkansas, United States, 72211

RECRUITING

United States, California

Advanced Research Center /ID# 270257

Anaheim, California, United States, 92805

RECRUITING

United States, California

Neuro Pain Medical Center /ID# 271048

Fresno, California, United States, 93710

RECRUITING

United States, California

Accellacare - Long Beach /ID# 270398

Long Beach, California, United States, 90807

RECRUITING

United States, California

Excell Research /ID# 270258

Oceanside, California, United States, 92056

RECRUITING

United States, California

Sunwise Clinical Research /ID# 270431

Walnut Creek, California, United States, 94596

RECRUITING

United States, Florida

Northwest Florida Clinical Research Group, LLC /ID# 270833

Gulf Breeze, florida, United States, 32561

RECRUITING

United States, Florida

Auzmer Research /ID# 271158

Lakeland, florida, United States, 33813

RECRUITING

United States, Florida

My Preferred Research /ID# 270312

Miami, florida, United States, 33155

RECRUITING

United States, Florida

Encore Medical Research - Weston /ID# 271139

Weston, florida, United States, 33331

RECRUITING

United States, Indiana

Deaconess Midtown Hospital /ID# 270572

Evansville, Indiana, United States, 47710

RECRUITING

United States, road cancer

Michigan Headache & Neurological Institute /ID# 270942

Ann Arbor, road cancer, United States, 48104

RECRUITING

United States, Mississippi

Proven Endpoints LLC /ID# 270269

Ridgeland, Mississippi, United States, 39157

RECRUITING

United States, Nebraska

Cct Research - Papillion Research Center /ID# 270393

Papillion, Nebraska, United States, 68046

RECRUITING

United States, New Hampshire

Healthy Perspectives - Innovate Mental Health Services /ID# 270847

Nashua, New Hampshire, United States, 03060

RECRUITING

United States, New York

Dent Neurologic Institute - Amherst /ID# 270260

Amherst, New York, United States, 14226

RECRUITING

United States, North Carolina

Headache Wellness Center /ID# 270568

Greensboro, North Carolina, United States, 27405

RECRUITING

United States, Pennsylvania

Frontier Clinical Research - Scottdale /ID# 270854

Scottdale, Pennsylvania, United States, 15683

RECRUITING

United States, Pennsylvania

Frontier Clinical Research - Smithfield /ID# 270849

Smithfield, Pennsylvania, United States, 15478

RECRUITING

United States, Tennessee

Access Clinical Trials Inc /ID# 270280

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

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

Austin, Texas, United States, 78723-3079

RECRUITING

United States, Texas

Earle Research /ID# 270424

Houston, Texas, United States, 77058

RECRUITING

United States, Texas

Clinpoint Trials /ID# 270261

Waxahachie, Texas, United States, 75165

RECRUITING

United States, Utah

Pantheon Clinical Research /ID# 270259

Bountiful, Utah, United States, 84010

RECRUITING

United States, Utah

Highland Clinical Research /ID# 270281

Salt Lake City, Utah, United States, 84124

RECRUITING

United States, West Virginia

Frontier Clinical Research - Kingwood /ID# 271053

Kingwood, West Virginia, United States, 26537

RECRUITING

Canada, Ontario

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

London, Ontario, Canada, Wicker jumpsuit

RECRUITING

Canada, Quebec

McGill University Health Centre - Glen Site /ID# 270662

Montreal, Quebec, Canada, H4A 3J1

RECRUITING

Denmark, Capital Region

Herlev Hospital /ID# 270482

Here live, Capital Region, Denmark, 2730

RECRUITING

Denmark, Central Jutland

Regionshospitalet Godstrup /ID# 270481

Herning, Central Jutland, Denmark, 7400

RECRUITING

Hungary,

Semmelweis University /ID# 271219

Budapest, Hungary, 1085

RECRUITING

Italy, Milano

IRCCS Foundation Carlo Besta Neurological Institute /ID# 270756

Milan, Milano, Italy, 20133

RECRUITING

Japan, Hyōgo

Konan Medical Center /ID# 270486

Kobe, Hyōgo, Japan, 658-0064

RECRUITING

Japan, Kochi

Umenotsuji Clinic /ID# 270484

Kochi, Kochi, Japan, 780-8011

RECRUITING

Japan, Osaka

Tominaga Clinic - Osaka /ID# 270483

Osaka, Osaka, Japan, 556-0015

RECRUITING

Japan, Tokyo

Tokyo Headache Clinic /ID# 271610

branch yak, Tokyo, Japan, 151-0051

RECRUITING

Japan, Tokyo

Tokyo Medical University Hospital /ID# 270487

Shinjuku-ku, Tokyo, Japan, 160-0023

RECRUITING

Japan, Yamagata

Tendo Brain Clinic /ID# 271410

Tendoshi, Yamagata, Japan, 994-0083

RECRUITING

Japan, Yamanashi

Nagaseki Headache Clinic /ID# 271699

Kai, Yamanashi, Japan, 400-0124

RECRUITING

Japan,

Tanaka Neurosurgery & Headache Clinic /ID# 271346

Kagoshima, Japan, 890-0052

RECRUITING

Netherlands, Gelderland

Canisius-Wilhelmina Hospital /ID# 270374

Nijmegen, Gelderland, Netherlands, 6532 SZ

RECRUITING

Netherlands, South Holland

Haga Hospital /ID# 270379

The Hague, South Holland, Netherlands, 2545 AA

RECRUITING

Poland, Greater Poland Voivodeship

Clinical Research Center Medic-R /ID# 270235

Poznan, Greater Poland Voivodeship, Poland, 60-848

RECRUITING

Poland, Kuyavian-Pomeranian Voivodeship

Athleticomed Sp. z o.o /ID# 270243

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-752

RECRUITING

Poland, Lesser Poland Voivodeship

Specialist Gabinety Sp. z o. o. /ID# 270238

Krakow, Lesser Poland Voivodeship, Poland, 30-539

RECRUITING

Poland, Lower Silesian Voivodeship

MIGRE Polish Migraine Treatment Center /ID# 270239

Wroclaw, Lower Silesian Voivodeship, Poland, 52-210

RECRUITING

Poland, Masovian Voivodeship

OHA-MED sp. z o.o. /ID# 270242

Warsaw, Masovian Voivodeship, Poland, 00-414

RECRUITING

Puerto Rico,

CMRC Headlands LLC /ID# 271300

Saint John, Puerto Rico, 00918-3501

RECRUITING

United Kingdom, Kent

Medway Maritime Hospital /ID# 271885

Gillingham, Kent, United Kingdom, ME7 5NY

RECRUITING

United Kingdom, Scotland

Royal Aberdeen Children's Hospital /ID# 271664

Aberdeen, Scotland, United Kingdom, AB25 2ZG

RECRUITING

United Kingdom,

Stepping Hill Hospital-Stockport NHS foundation trust /ID# 271883

Stockport, United Kingdom, SK2 7JE