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
ID05156398
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents 6gt;= 6 to <18 Years of Age
Led by Pfizer · Updated on 2026-06-05
640
Participants Needed
91
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of rimegepant compared to a placebo for preventing migraines in children and adolescents aged 6 to under 18 years who experience episodic migraine. This Phase 3 randomized, double-blind study aims to understand how rimegepant may help reduce migraine frequency and improve quality of life in this young population. Participants receive either rimegepant tablets at doses of 75 mg or 50 mg (two 25 mg orally disintegrating tablets) or a matching placebo at the same doses. The study includes a 12-week double-blind treatment phase during which the effects of the medication on migraine days are closely monitored. During the study, participants will track their migraine days and medication use, and complete quality of life assessments such as the Pediatric Quality of Life Inventory. Researchers will evaluate changes in migraine frequency, the use of acute migraine medications, and safety over 72 weeks, including monitoring for liver-related side effects. The primary measurement is the change in average monthly migraine days over the initial 12 weeks of treatment.
CONDITIONS
Brief Title
Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
Who Can Participate
Age: 6Years - 17Years
All Genders
Eligibility Criteria
You may qualify if you...
- Children and adolescents aged 6 to under 18 years at time of consent/assent
- History of migraine for at least 6 months with or without aura
- 14 or fewer headache days per month during the 3 months before screening
- 6 or more migraine days and 14 or fewer headache days during observation period
- Pediatric Migraine Disability Assessment Scale score between >10 and 6450 indicating mild to moderate disruption
- Ability to verbally distinguish migraine attacks from other headache types
- Migraine attacks lasting 4 to 72 hours if untreated
- Stable dose of prophylactic migraine medication for at least 3 months prior if applicable
- Weight of at least 15 kg for children or 40 kg for adolescents at screening
You will not qualify if you...
- History of basilar migraine, cluster headaches, or hemiplegic migraine
- Continuous migraine within 1 month prior to screening
- History or diagnosis of migraine complications
- Clinically significant pain syndrome interfering with study participation
- Uncontrolled or untreated psychiatric conditions within 6 months prior to screening
- History of psychosis, mania, suicidal behavior, or risk of self-harm
- Major psychiatric disorders
- Current diagnosis or history of substance abuse
- Moderate or severe head trauma, neurological disorders, or systemic diseases affecting CNS function
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants receive either Rimegepant or a matching placebo as preventative treatment for migraine.
Weekly visits for up to 12 weeks
Follow-up
Duration - Up to 60 weeks after treatment
Participants are monitored for safety and tolerability of the treatment, including evaluation of hepatic-related adverse events.
Periodic visits for safety assessments
Trial Site Locations
Total: 91 locations
1
The Belinga Clinic
Fort Smith, Arkansas, United States, 72901
Active, Not Recruiting
2
Advanced Investigative Medicine, Inc.
Hawthorne, California, United States, 90250
Actively Recruiting
3
Velocity Clinical Research San Diego
La Mesa, California, United States, 91942
Active, Not Recruiting
4
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States, 80907
Active, Not Recruiting
5
Advanced Neurosciences Research, LLC
Fort Collins, Colorado, United States, 80528
Terminated
6
Meridian Clinical Research, LLC
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
7
Velocity Clinical Research, Washington DC
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
8
Accel Research Sites Network - Edgewater Clinical Research Unit
Edgewater, Florida, United States, 32132
Active, Not Recruiting
9
Direct Helpers Research Center
Hialeah, Florida, United States, 33012
Actively Recruiting
10
New Med Research, Inc
Hollywood, Florida, United States, 33020
Terminated
11
Complete Health Research
Ormond Beach, Florida, United States, 32174
Active, Not Recruiting
12
D&H Tamarac Research Center LLC
Tamarac, Florida, United States, 33321
Actively Recruiting
13
Santos Research Center, CORP
Tampa, Florida, United States, 33615
Actively Recruiting
14
Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
15
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, United States, 30328
Active, Not Recruiting
16
Meridian Clinical Research, LLC
Savannah, Georgia, United States, 31406
Active, Not Recruiting
17
Extraordinary Family Healthcare
Snellville, Georgia, United States, 30078
Active, Not Recruiting
18
Renew Health Clinical Research LLC
Snellville, Georgia, United States, 30078
Active, Not Recruiting
19
Northwest Clinical Trials, Inc.
Boise, Idaho, United States, 83704
Actively Recruiting
20
Diamond Headache Clinic
Chicago, Illinois, United States, 60642
Terminated
21
Nola Research Works, LLC
New Orleans, Louisiana, United States, 70125
Actively Recruiting
22
Safe Haven Clinical Research
Clinton, Mississippi, United States, 39056
Actively Recruiting
23
Roy Blunt NextGen Precision Health Building
Columbia, Missouri, United States, 65211
Actively Recruiting
24
University of Missouri Health Care - Investigation Pharmacy
Columbia, Missouri, United States, 65212
Actively Recruiting
25
University of Missouri-Clinical and Translational Sciences Unit
Columbia, Missouri, United States, 65212
Actively Recruiting
26
University of Missouri
Columbia, Missouri, United States, 65212
Actively Recruiting
27
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, United States, 68803
Actively Recruiting
28
Papillion Research Center/CCT Research
Papillion, Nebraska, United States, 68046
Actively Recruiting
29
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Active, Not Recruiting
30
Dent Neurosciences Research Center, Inc.
Amherst, New York, United States, 14226
Active, Not Recruiting
31
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
32
Carolina Institute for Clinical Research, LLC
Fayetteville, North Carolina, United States, 28303
Active, Not Recruiting
33
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
34
Velocity Clinical Research
Cincinnati, Ohio, United States, 45242
Active, Not Recruiting
35
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
Active, Not Recruiting
36
Coastal Pediatric Research
Charleston, South Carolina, United States, 29414
Active, Not Recruiting
37
Tribe Clinical Research LLC
Greenville, South Carolina, United States, 29607
Terminated
38
Avera McKennan Hospital & University Health Center
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
39
Avera Research Institute
Sioux Falls, South Dakota, United States, 57108
Actively Recruiting
40
Avera Medical Group Pediatrics - Dawley Farm
Sioux Falls, South Dakota, United States, 57110
Actively Recruiting
41
Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
Terminated
42
Alina Clinical Trials, LLC.
Dallas, Texas, United States, 75209
Actively Recruiting
43
North Texas Center for Clinical Research
Frisco, Texas, United States, 75034
Actively Recruiting
44
DM Clinical Research - Cy Fair
Houston, Texas, United States, 77065
Actively Recruiting
45
SCLA Management - Drop Box
Houston, Texas, United States, 77077
Actively Recruiting
46
SCLA Management Office
Houston, Texas, United States, 77077
Actively Recruiting
47
NeuroCare Plus
Houston, Texas, United States, 77094
Actively Recruiting
48
Red Star Research, LLC
Lake Jackson, Texas, United States, 77566
Active, Not Recruiting
49
DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials
McAllen, Texas, United States, 78503
Actively Recruiting
50
DCT-Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, United States, 78258
Actively Recruiting
51
Texas Institute for Neurological Disorders
Sherman, Texas, United States, 75092
Active, Not Recruiting
52
DM Clinical Research (Administrative Office Only)
Tomball, Texas, United States, 77375
Actively Recruiting
53
Victoria Clinical Research Group
Victoria, Texas, United States, 77901
Terminated
54
Meridian Clinical Research, LLC
Portsmouth, Virginia, United States, 23703
Active, Not Recruiting
55
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada, V6H 3V4
Terminated
56
Centre Hospitalier Intercommunal de Creteil
Créteil, France, 94000
Actively Recruiting
57
Centre Hospitalier Universitaire de Montpellier
Montpellier, France, 34295
Active, Not Recruiting
58
Hopital des Enfants
Toulouse, France, 31059
Actively Recruiting
59
UOSVD Centro Epilessia ed EEG dellEta Evolutiva
Bari, BARI / Puglia, Italy, 70132
Actively Recruiting
60
Sapienza Universita di Roma Polo Pontino - ICOT, Headache clinic
Latina, Latina/lazio, Italy, 04100
Actively Recruiting
61
IRCCS San Raffaele
Rome, Lazio, Italy, 00166
Actively Recruiting
62
Istituto Neurologico "Carlo Besta" Fondazione IRCCS
Milan, Lombardy, Italy, 20133
Actively Recruiting
63
Divisione di Neurologia, Ospedale Pediatrico Bambino Gesu
Rome, Rome/lazio, Italy, 00165
Actively Recruiting
64
ASST Spedali Civili di Brescia
Brescia, Italy, 25069
Actively Recruiting
65
Jinnouchi Neurosurgical Clinic
Kasuga-shi, Fukuoka, Japan, 816-0802
Actively Recruiting
66
Hikita Pediatric Clinic
Kiryu-shi, Gunma, Japan, 376-0035
Actively Recruiting
67
Konan Medical Center
Higashinada-ku Kobe-shi, Hyōgo, Japan, 658-0064
Actively Recruiting
68
Yamaguchi Clinic
Nishinomiya-shi, Hyōgo, Japan, 663-8204
Actively Recruiting
69
Mito Kyodo General Hospital
Mito, Ibaraki, Japan, 310-0015
Not Yet Recruiting
70
Tanaka Neurosurgery & Headache Clinic
Kagoshima, Kagoshima-ken, Japan, 890-0052
Actively Recruiting
71
Atago Hospital
Kochi, Kochi, Japan, 780-0051
Actively Recruiting
72
Sendai Headache and Neurology Clinic
Taihaku-ku Sendai-shi, Miyagi, Japan, 982-0014
Actively Recruiting
73
Tennouji Dai Brain Clinic
Abeno-ku Osaka-shi, Osaka, Japan, 545-0053
Actively Recruiting
74
Tominaga Clinic
Naniwa-ku, Osaka, Japan, 556-0015
Actively Recruiting
75
Saitama Neuropsychiatric Institute
Chuo-ku Saitama-shi, Saitama, Japan, 338-8577
Actively Recruiting
76
Tokyo Headache Clinic
Shibuya-ku, Tokyo, Japan, 151-0051
Actively Recruiting
77
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan, 160-0023
Actively Recruiting
78
Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.
Poznan, Greater Poland Voivodeship, Poland, 61-731
Actively Recruiting
79
Wojewodzki Specjalistyczny Szpital Dzieciecy
Krakow, Lesser Poland Voivodeship, Poland, 31-503
Actively Recruiting
80
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw, Lower Silesian Voivodeship, Poland, 52-210
Actively Recruiting
81
NZOZ Neuromed M. i M. Nastaj Sp. P.
Lublin, Lublin Voivodeship, Poland, 20-064
Actively Recruiting
82
MTZ Clinical Research Powered by Pratia
Warsaw, Masovian Voivodeship, Poland, 02-172
Actively Recruiting
83
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
Katowice, Silesian Voivodeship, Poland, 40-123
Active, Not Recruiting
84
Neurologia Slaska Centrum Medyczne
Katowice, Silesian Voivodeship, Poland, 40-689
Actively Recruiting
85
Next Stage Sp. Z o.o.
Warsaw, WOJ. Mazowieckie, Poland, 02-121
Actively Recruiting
86
Hospital Universitari Parc Tauli
Sabadell, Barcelona, Spain, 08208
Actively Recruiting
87
Hospital Clinico Universitario de Valladolid (HCUV)
Valladolid, Castille and León, Spain, 47003
Actively Recruiting
88
Hospital Alvaro Cunqueiro
Vigo, Galicia, Spain, 36312
Actively Recruiting
89
Instituto de Investigaciones del Sueno
Madrid, Spain, 28036
Actively Recruiting
90
Virgen del Rocio Hospital
Seville, Spain, 41013
Actively Recruiting
91
Hospital Universitario y Politecnico La Fe
Valencia, Spain, 46026
Actively Recruiting
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Research Team
P
Pfizer Pfizer CT.gov Call Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
2
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