Actively Recruiting
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
Eligibility Criteria
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
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
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
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
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