Gepants for headache prevention in children and adolescents: A multicenter chart review study.
Lauren Shin, Olivia Mentz, Amy A Gelfand...
https://pubmed.ncbi.nlm.nih.gov/41235617Actively Recruiting
Phase 3
Age: 12Years - 17Years
All Genders
ID06810505
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
Led by AbbVie · Updated on 2026-06-04
420
Participants Needed
64
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Migraine is a condition that often causes moderate to severe headaches on one side of the head, sometimes accompanied by symptoms like throbbing, nausea, vomiting, and sensitivity to light and sound. This research aims to evaluate the safety and effectiveness of atogepant compared to a placebo in preventing chronic migraine in participants aged 12 to 17 years. Atogepant is already approved for adults and is now being studied for younger patients to understand its impact on this age group. Participants will be randomly assigned to receive either atogepant or a placebo, both given as oral tablets once daily for 12 weeks. The study is designed to be double-blind, so neither the participants nor the doctors will know who receives the active medicine or the placebo. After the 12-week treatment period, participants will be followed for an additional 4 weeks for further observation. During the study, participants will attend regular visits at a hospital or clinic where they will complete daily diaries, undergo medical assessments, blood tests, and questionnaires to monitor side effects and treatment effects. Researchers will measure the number of participants experiencing adverse events and changes in monthly migraine days, among other outcomes. The total participation time, including treatment and follow-up, will be approximately 16 weeks.
CONDITIONS
Brief 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
You may qualify if you...
- History of chronic migraine with or without aura for at least 6 months according to ICHD-3 (2018)
- Completion of eDiary for at least 20 of 28 days during screening/baseline
- At least 15 headache days in the last 28 days
- At least 8 migraine days in the last 28 days
- Age between 12 and 17 years
You will not qualify if you...
- Clinically significant hypertension as judged by the investigator
- History of significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 12 weeks
Participants take oral atogepant or placebo once daily to prevent chronic migraine.
1 baseline visit and multiple follow-up visits during treatment
Trial Site Locations
Total: 64 locations
1
Rehabilitation and Neurological Services /ID# 270782
Huntsville, Alabama, United States, 35805
Actively Recruiting
2
Preferred Research Partners - Fayetteville /ID# 270419
Fayetteville, Arkansas, United States, 72703
Completed
3
Preferred Research Partner, Inc /ID# 270389
Little Rock, Arkansas, United States, 72211
Actively Recruiting
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 Coimbra /ID# 277993
Coimbra, Portugal, 3000-075
Actively Recruiting
58
Unidade Local de Saude de Santa Maria /ID# 277997
Lisbon, Portugal, 1649-035
Actively Recruiting
59
Unidade Local de Saude de Santo Antonio /ID# 278090
Porto, Portugal, 4099-003
Actively Recruiting
60
CMRC Headlands LLC /ID# 271300
San Juan, Puerto Rico, 00918-3501
Actively Recruiting
61
Great Ormond Street Children's Hospital /ID# 271550
London, Greater London, United Kingdom, WC1N 3HZ
Actively Recruiting
62
Medway Maritime Hospital /ID# 271885
Gillingham, Kent, United Kingdom, ME7 5NY
Actively Recruiting
63
Royal Aberdeen Children's Hospital /ID# 271664
Aberdeen, Scotland, United Kingdom, AB25 2ZG
Actively Recruiting
64
Stepping Hill Hospital-Stockport NHS foundation trust /ID# 271883
Stockport, United Kingdom, SK2 7JE
Actively Recruiting
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Research Team
A
ABBVIE CALL CENTER
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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