Actively Recruiting

Phase 3
Age: 12Years - 17Years
All Genders
NCT06810505

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

Led by AbbVie · Updated on 2026-05-12

420

Participants Needed

61

Research Sites

315 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • History of chronic migraine with or without aura for at least 6 months according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) (2018)
  • During the last 28 days of screening/baseline, completed an electronic diary for at least 20 days
  • During the last 28 days of screening/baseline, had 15 or more headache days
  • During the last 28 days of screening/baseline, had 8 or more migraine days
Not Eligible

You will not qualify if you...

  • Clinically significant hypertension as judged by the investigator
  • History of any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular, or neurologic disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 61 locations

1

Rehabilitation & Neurological Services /ID# 270782

Huntsville, Alabama, United States, 35805

Actively Recruiting

2

Preferred Research Partner, Inc /ID# 270389

Little Rock, Arkansas, United States, 72211

Actively Recruiting

3

Preferred Research Partners /ID# 270419

Little Rock, Arkansas, United States, 72211

Completed

4

Advanced Research Center /ID# 270257

Anaheim, California, United States, 92805

Actively Recruiting

5

Neuro Pain Research Center /ID# 271048

Fresno, California, United States, 93710

Actively Recruiting

6

Accellacare - Long Beach /ID# 270398

Long Beach, California, United States, 90807

Actively Recruiting

7

Excell Research /ID# 270258

Oceanside, California, United States, 92056

Actively Recruiting

8

Lumos Clinical Research Center /ID# 270582

San Jose, California, United States, 95124

Actively Recruiting

9

Sunwise Clinical Research /ID# 270431

Walnut Creek, California, United States, 94596

Actively Recruiting

10

Northwest Florida Clinical Research Group, LLC /ID# 270833

Gulf Breeze, Florida, United States, 32561

Actively Recruiting

11

Auzmer Research /ID# 271158

Lakeland, Florida, United States, 33813

Completed

12

My Preferred Research /ID# 270312

Miami, Florida, United States, 33155

Actively Recruiting

13

Encore Medical Research - Weston /ID# 271139

Weston, Florida, United States, 33331

Actively Recruiting

14

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

Winter Park, Florida, United States, 32789

Actively Recruiting

15

Deaconess Midtown Hospital /ID# 270572

Evansville, Indiana, United States, 47710

Actively Recruiting

16

Michigan Headache & Neurological Institute /ID# 270942

Ann Arbor, Michigan, United States, 48104

Actively Recruiting

17

Proven Endpoints LLC /ID# 270269

Ridgeland, Mississippi, United States, 39157

Actively Recruiting

18

Cct Research - Papillion Research Center /ID# 270393

Papillion, Nebraska, United States, 68046

Actively Recruiting

19

Healthy Perspectives - Innovate Mental Health Services /ID# 270847

Nashua, New Hampshire, United States, 03060

Actively Recruiting

20

Dent Neurologic Institute - Amherst /ID# 270260

Amherst, New York, United States, 14226

Actively Recruiting

21

Headache Wellness Center /ID# 270568

Greensboro, North Carolina, United States, 27405

Actively Recruiting

22

Frontier Clinical Research - Scottdale /ID# 270854

Scottdale, Pennsylvania, United States, 15683

Actively Recruiting

23

Frontier Clinical Research - Smithfield /ID# 270849

Smithfield, Pennsylvania, United States, 15478

Actively Recruiting

24

Access Clinical Trials Inc /ID# 270280

Nashville, Tennessee, United States, 37203

Actively Recruiting

25

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

Austin, Texas, United States, 78723-3079

Actively Recruiting

26

Earle Research /ID# 270424

Houston, Texas, United States, 77058

Actively Recruiting

27

Clinpoint Trials /ID# 270261

Waxahachie, Texas, United States, 75165

Actively Recruiting

28

Pantheon Clinical Research /ID# 270259

Bountiful, Utah, United States, 84010

Actively Recruiting

29

Alpine Research Organization - Clinton /ID# 276527

Clinton, Utah, United States, 84015

Actively Recruiting

30

Highland Clinical Research /ID# 270281

Salt Lake City, Utah, United States, 84124

Actively Recruiting

31

Frontier Clinical Research - Kingwood /ID# 271053

Kingwood, West Virginia, United States, 26537

Actively Recruiting

32

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

London, Ontario, Canada, N6A 5W9

Actively Recruiting

33

McGill University Health Centre - Glen Site. /ID# 270662

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

34

Herlev Hospital /ID# 270482

Herlev, Capital Region, Denmark, 2730

Actively Recruiting

35

Regionshospitalet Godstrup /ID# 270481

Herning, Central Jutland, Denmark, 7400

Actively Recruiting

36

Semmelweis Egyetem /ID# 271219

Budapest, Hungary, 1085

Actively Recruiting

37

Rozsavolgyi Rendelo-Ceba Bt. /ID# 271500

Budapest, Hungary, 1141

Actively Recruiting

38

Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 270756

Milan, Milano, Italy, 20133

Actively Recruiting

39

Ospedale Pediatrico Bambino Gesù /ID# 270759

Rome, Roma, Italy, 00165

Actively Recruiting

40

Konan Medical Center /ID# 270486

Kobe, Hyōgo, Japan, 658-0064

Actively Recruiting

41

Umenotsuji Clinic /ID# 270484

Kochi, Kochi, Japan, 780-8011

Actively Recruiting

42

Tominaga Clinic - Osaka /ID# 270483

Osaka, Osaka, Japan, 556-0015

Actively Recruiting

43

Tokyo Headache Clinic /ID# 271610

Shibuya-ku, Tokyo, Japan, 151-0051

Actively Recruiting

44

Tokyo Medical University Hospital /ID# 270487

Shinjuku-ku, Tokyo, Japan, 160-0023

Actively Recruiting

45

Tendo Brain Clinic /ID# 271410

Tendo-shi, Yamagata, Japan, 994-0083

Actively Recruiting

46

Nagaseki Headache Clinic /ID# 271699

Kai, Yamanashi, Japan, 400-0124

Actively Recruiting

47

Tanaka Neurosurgery & Headache Clinic /ID# 271346

Kagoshima, Japan, 890-0052

Actively Recruiting

48

Canisius-Wilhelmina Ziekenhuis /ID# 270374

Nijmegen, Gelderland, Netherlands, 6532 SZ

Actively Recruiting

49

HagaZiekenhuis /ID# 270379

The Hague, South Holland, Netherlands, 2545 AA

Actively Recruiting

50

Clinical Research Center Medic-R /ID# 270235

Poznan, Greater Poland Voivodeship, Poland, 60-848

Actively Recruiting

51

Athleticomed Sp. z o.o /ID# 270243

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

Actively Recruiting

52

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

Krakow, Lesser Poland Voivodeship, Poland, 30-539

Actively Recruiting

53

MIGRE Polskie Centrum Leczenia Migreny /ID# 270239

Wroclaw, Lower Silesian Voivodeship, Poland, 52-210

Actively Recruiting

54

Oha-Med Sp. Z O.O /ID# 270242

Warsaw, Masovian Voivodeship, Poland, 01-018

Actively Recruiting

55

Hospital da Luz /ID# 277991

Lisbon, Lisbon District, Portugal, 1500-650

Actively Recruiting

56

Unidade Local de Saude de Almada-Seixal, EPE /ID# 278092

Almada, Setúbal District, Portugal, 2805-267

Actively Recruiting

57

Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 278090

Porto, Portugal, 4099-003

Actively Recruiting

58

CMRC Headlands LLC /ID# 271300

San Juan, Puerto Rico, 00918-3501

Actively Recruiting

59

Medway Maritime Hospital /ID# 271885

Gillingham, Kent, United Kingdom, ME7 5NY

Actively Recruiting

60

Royal Aberdeen Children's Hospital /ID# 271664

Aberdeen, Scotland, United Kingdom, AB25 2ZG

Actively Recruiting

61

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

Stockport, United Kingdom, SK2 7JE

Actively Recruiting

Loading map...

Research Team

A

ABBVIE CALL CENTER

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here