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: 6Years - 17Years
All Genders
ID05711394
A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Episodic Migraine in Pediatric Subjects 6-17 Years of Age.
Led by AbbVie · Updated on 2026-05-13
450
Participants Needed
98
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating atogepant, a medicine approved for adults, to study its safety and how well it works in children and teens aged 6 to 17 with episodic migraine. Episodic migraine involves moderate to severe headaches on one side of the head, often with symptoms like throbbing, nausea, vomiting, and sensitivity to light and sound. This Phase 3, randomized, double-blind study aims to fill the gap in approved treatments for pediatric migraine sufferers. Participants aged 6 to 17 will be divided into groups receiving either a placebo, low-dose atogepant, or high-dose atogepant tablets once daily for 12 weeks. Children aged 6 to 11 will first be part of a pharmacokinetic substudy to determine the appropriate doses. After the 12-week treatment, participants will either have a follow-up visit 4 weeks later or join an extension study to continue atogepant treatment for an additional 52 weeks. During the study, participants will attend regular visits at hospitals or clinics, where medical assessments, blood tests, side effect checks, and questionnaires will be completed. Researchers will measure changes in the number of migraine and headache days, adverse events, medication use, and quality of life scores. Safety and effectiveness will be monitored throughout the study, which is expected to continue until May 2028.
CONDITIONS
Brief Title
A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine
Who Can Participate
Age: 6Years - 17Years
All Genders
Eligibility Criteria
You may qualify if you...
- Weight is 20 kg (44 lbs) or more and less than 135 kg (298 lbs).
- History of episodic migraine with or without aura for at least 6 months, diagnosed according to International Classification of Headache Disorders (ICHD)-3 (2018).
- 4 to 14 migraine days and fewer than 15 headache days in the 28-day baseline period.
- For the pharmacokinetic substudy, age is 6 to 11 years with migraine and judged appropriate for preventive treatment by the investigator.
You will not qualify if you...
- History of migraine brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018).
- Current diagnosis of chronic migraine according to ICHD-3 (2018).
- Current diagnosis of new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
Duration - Duration as per investigator's judgment before double-blind treatment
Participants aged 6 to 11 are given oral tablets of atogepant Dose A or Dose B to determine the appropriate dose for the double-blind treatment period.
Visits as needed for dose determination
Treatment
Duration - 12 weeks
Participants aged 6 to 17 receive daily oral tablets of either high dose, low dose atogepant, or placebo for 12 weeks to prevent episodic migraine.
Regular visits during the 12-week treatment period
Follow-up
Duration - 4 weeks after treatment ends
Participants are monitored for adverse events and changes in disease activity through 16 weeks from baseline.
Visits for safety monitoring post-treatment
Trial Site Locations
Total: 98 locations
1
Rehabilitation & Neurological Services /ID# 248517
Huntsville, Alabama, United States, 35805-4046
Actively Recruiting
2
The Center for Clinical Trials - Saraland /ID# 271604
Saraland, Alabama, United States, 36571
Actively Recruiting
3
Preferred Research Partners /ID# 249729
Little Rock, Arkansas, United States, 72211
Actively Recruiting
4
Preferred Research Partners /ID# 270406
Little Rock, Arkansas, United States, 72211
Completed
5
Advanced Research Center /ID# 251381
Anaheim, California, United States, 92805
Actively Recruiting
6
Alliance for Research Alliance for Wellness /ID# 248521
Long Beach, California, United States, 90807
Actively Recruiting
7
Excell Research, Inc /ID# 247532
Oceanside, California, United States, 92056
Actively Recruiting
8
Lumos Clinical Research Center /ID# 249731
San Jose, California, United States, 95124-4108
Actively Recruiting
9
Sunwise Clinical Research /ID# 248529
Walnut Creek, California, United States, 94596
Actively Recruiting
10
Advanced Neurosciences Research, LLC /ID# 247592
Fort Collins, Colorado, United States, 80528
Completed
11
Northwest Florida Clinical Research Group, LLC /ID# 251382
Gulf Breeze, Florida, United States, 32561-4495
Actively Recruiting
12
Advanced Research Institute of Miami /ID# 248539
Homestead, Florida, United States, 33030-4613
Completed
13
My Preferred Research LLC /ID# 249720
Miami, Florida, United States, 33155
Actively Recruiting
14
Asclepes Research Centers - Spring Hill /ID# 248525
Spring Hill, Florida, United States, 34609-5692
Completed
15
Coastal Georgia Child Neurology /ID# 249733
Brunswick, Georgia, United States, 31520-1601
Actively Recruiting
16
Deaconess Clinic - Gateway Health Center /ID# 247589
Newburgh, Indiana, United States, 47630
Actively Recruiting
17
College Park Family Care Center Overland Park /ID# 249734
Overland Park, Kansas, United States, 66210-2761
Completed
18
Michigan Headache & Neurological Institute (MHNI) /ID# 247468
Ann Arbor, Michigan, United States, 48104-5131
Actively Recruiting
19
Proven Endpoints LLC /ID# 258066
Ridgeland, Mississippi, United States, 39157
Actively Recruiting
20
Cognitive Clinical Trials (CCT) - Papillion /ID# 248536
Papillion, Nebraska, United States, 68046-4131
Actively Recruiting
21
Goryeb Childrens Hospital /ID# 249724
Morristown, New Jersey, United States, 07960
Actively Recruiting
22
Dent Neurologic Institute - Amherst /ID# 248534
Amherst, New York, United States, 14226
Actively Recruiting
23
Modern Migraine MD /ID# 258074
New York, New York, United States, 10001
Completed
24
Headache Wellness Center /ID# 251018
Greensboro, North Carolina, United States, 27405
Actively Recruiting
25
Patient Priority Clinical Sites, LLC /ID# 247535
Cincinnati, Ohio, United States, 45215-2123
Actively Recruiting
26
Cincinnati Childrens Hospital Medical Center /ID# 258070
Cincinnati, Ohio, United States, 45229
Actively Recruiting
27
CincyScience /ID# 249726
West Chester, Ohio, United States, 45069
Completed
28
Lynn Institute of Oklahoma City /ID# 247600
Oklahoma City, Oklahoma, United States, 73112
Actively Recruiting
29
Children's Hospital of Philadelphia - Main /ID# 258071
Philadelphia, Pennsylvania, United States, 19104-4319
Actively Recruiting
30
Le Bonheur Children's Hospital /ID# 261084
Memphis, Tennessee, United States, 38103
Actively Recruiting
31
Access Clinical Trials, Inc. /ID# 248532
Nashville, Tennessee, United States, 37203
Actively Recruiting
32
UT Health Austin at Dell Children's Neurology Clinic /ID# 264082
Austin, Texas, United States, 78723-3079
Actively Recruiting
33
FutureSearch Trials of Neurology /ID# 247470
Austin, Texas, United States, 78731
Actively Recruiting
34
3A Research - East El Paso /ID# 248516
El Paso, Texas, United States, 79925-7945
Actively Recruiting
35
Earle Research /ID# 248501
Friendswood, Texas, United States, 77546
Actively Recruiting
36
Family Psychiatry of The Woodlands /ID# 249727
The Woodlands, Texas, United States, 77381
Actively Recruiting
37
ClinPoint Trials /ID# 248540
Waxahachie, Texas, United States, 75165-1430
Actively Recruiting
38
Pantheon Clinical Research /ID# 251601
Bountiful, Utah, United States, 84010-4968
Actively Recruiting
39
Alpine Research Organization - Clinton /ID# 276497
Clinton, Utah, United States, 84015
Actively Recruiting
40
Highland Clinical Research /ID# 247590
Salt Lake City, Utah, United States, 84124
Actively Recruiting
41
Office of Maria Ona /ID# 249738
Franklin, Virginia, United States, 23851
Actively Recruiting
42
Core Clinical Research /ID# 249721
Everett, Washington, United States, 98201
Completed
43
Uza /Id# 247339
Edegem, Antwerpen, Belgium, 2650
Actively Recruiting
44
AZ Sint-Jan Brugge /ID# 247201
Bruges, West-Vlaanderen, Belgium, 8000
Actively Recruiting
45
Stollery Children's Hospital /ID# 249672
Edmonton, Alberta, Canada, T6G 2B7
Actively Recruiting
46
London Health Sciences Center- University Hospital /ID# 252979
London, Ontario, Canada, N6A 5W9
Actively Recruiting
47
McGill University Health Centre - Glen Site. /ID# 247271
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
48
Herlev Hospital /ID# 247724
Herlev, Capital Region, Denmark, 2730
Actively Recruiting
49
Regionshospitalet Godstrup /ID# 247902
Herning, Central Jutland, Denmark, 7400
Actively Recruiting
50
Aalborg Sygehus Nord /ID# 247428
Aalborg, North Denmark, Denmark, 9000
Actively Recruiting
51
CHU Amiens-Picardie Site Sud /ID# 248833
Amiens, Somme, France, 80054
Completed
52
Centre Hosp Intercommunal de Creteil /ID# 248832
Créteil, Val-de-Marne, France, 94000
Actively Recruiting
53
CHU Toulouse - Hôpital des enfants /ID# 247553
Toulouse, France, 31059
Actively Recruiting
54
MIND Clinic /ID# 248687
Budapest, Hungary, 1024
Completed
55
Semmelweis Egyetem /ID# 248360
Budapest, Hungary, 1085
Actively Recruiting
56
Shamir Medical Center /ID# 256857
Beer Ya'akov, Central District, Israel, 70300
Actively Recruiting
57
Hillel Yaffe Medical Center /ID# 246747
Hadera, Haifa District, Israel, 38100
Completed
58
The Chaim Sheba Medical Center /ID# 246746
Ramat Gan, Tel Aviv, Israel, 5265601
Actively Recruiting
59
Tel Aviv Sourasky Medical Center /ID# 247466
Tel Aviv, Tel Aviv, Israel, 6423906
Actively Recruiting
60
Bnai Zion Medical Center /ID# 247469
Haifa, Israel, 3339419
Actively Recruiting
61
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 247581
Milan, Milano, Italy, 20133
Actively Recruiting
62
Ospedale Pediatrico Bambino Gesù /ID# 247647
Rome, Roma, Italy, 00165
Actively Recruiting
63
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone /ID# 247638
Palermo, Italy, 90127
Actively Recruiting
64
Konan Medical Center /ID# 254457
Kobe, Hyōgo, Japan, 658-0064
Actively Recruiting
65
Yamaguchi Clinic /ID# 254753
Nishinomiya, Hyōgo, Japan, 663-8204
Actively Recruiting
66
Umenotsuji Clinic /ID# 254453
Kochi, Kochi, Japan, 780-8011
Actively Recruiting
67
Sendai Headache and Neurology Clinic Medical Corporation /ID# 254211
Sendai, Miyagi, Japan, 982-0014
Actively Recruiting
68
Tominaga Clinic - Osaka /ID# 254450
Osaka, Osaka, Japan, 556-0015
Actively Recruiting
69
Tokyo Medical University Hospital /ID# 254459
Shinjuku-ku, Tokyo, Japan, 160-0023
Actively Recruiting
70
Tatsuoka Neurology Clinic /ID# 254455
Kyoto, Japan, 600-8811
Actively Recruiting
71
Canisius-Wilhelmina Ziekenhuis /ID# 253065
Nijmegen, Gelderland, Netherlands, 6532 SZ
Actively Recruiting
72
HagaZiekenhuis /ID# 247318
The Hague, South Holland, Netherlands, 2545 AA
Actively Recruiting
73
ZorgSaam Zorggroep Zeeuws-Vlaanderen /ID# 247301
Terneuzen, Zeeland, Netherlands, 4535 PA
Actively Recruiting
74
Clinical Research Center Medic-R /ID# 247383
Poznan, Greater Poland Voivodeship, Poland, 60-848
Actively Recruiting
75
Athleticomed Sp. z o.o /ID# 248789
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-752
Actively Recruiting
76
Specjalistyczne Gabinety Sp. z o.o. /ID# 247384
Krakow, Lesser Poland Voivodeship, Poland, 30-539
Actively Recruiting
77
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej /ID# 247382
Lublin, Lublin Voivodeship, Poland, 20-582
Actively Recruiting
78
Oha-Med Sp. Z O.O /ID# 248614
Warsaw, Masovian Voivodeship, Poland, 01-018
Actively Recruiting
79
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak /ID# 247381
Wroclaw, Poland, 52-210
Actively Recruiting
80
Clinical Research Investigator Group /ID# 261254
Bayamón, Puerto Rico, 00960
Completed
81
Dr. Samuel Sanchez PSC /ID# 248495
Caguas, Puerto Rico, 00727
Actively Recruiting
82
Puerto Rico Health Institute /ID# 249741
Dorado, Puerto Rico, 00646
Actively Recruiting
83
CMRC Headlands LLC /ID# 251634
San Juan, Puerto Rico, 00918-3501
Actively Recruiting
84
PRCCI Clinical Research Center /ID# 262726
San Juan, Puerto Rico, 00927
Completed
85
Spitalul Clinic de Copii Dr. Victor Gomoiu /ID# 248431
Bucharest, Bucharest, Romania, 022102
Completed
86
Spitalul Clinic de Urgenta pentru Copii Cluj Napoca /ID# 248595
Cluj-Napoca, Cluj, Romania, 400012
Completed
87
Delta Health Care S.R.L /ID# 248130
Bucharest, Romania, 014146
Completed
88
Hospital Universitario Vall de Hebron /ID# 247967
Barcelona, Spain, 08035
Actively Recruiting
89
Hospital Clinico San Carlos /ID# 249267
Madrid, Spain, 28040
Actively Recruiting
90
Hospital Universitario 12 de Octubre /ID# 275578
Madrid, Spain, 28041
Actively Recruiting
91
Hospital Universitario Virgen del Rocio /ID# 248632
Seville, Spain, 41013
Actively Recruiting
92
Hospital Universitario y Politecnico La Fe /ID# 247969
Valencia, Spain, 46026
Completed
93
Sodersjukhuset /ID# 248279
Stockholm, Stockholm County, Sweden, 118 83
Actively Recruiting
94
Vastra Gotealandsregionen Regionhalsan /ID# 248277
Mölnlycke, Sweden, 435 30
Actively Recruiting
95
Great Ormond Street Children's Hospital /ID# 262933
London, Greater London, United Kingdom, WC1N 3HZ
Actively Recruiting
96
Medway NHS Foundation Trust /ID# 249065
Gillingham, Kent, United Kingdom, ME7 5NY
Actively Recruiting
97
NHS Grampian /ID# 249067
Aberdeen, United Kingdom, AB15 6RE
Actively Recruiting
98
Stepping Hill Hospital-Stockport NHS foundation trust /ID# 261121
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
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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