Actively Recruiting
Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
Led by Pfizer · Updated on 2026-05-11
640
Participants Needed
90
Research Sites
560 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to \<18 years with episodic migraine.
CONDITIONS
Official Title
Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject has at least a 6 month history of migraine (with or without aura)
- 14 or fewer headache days per month during the 3 months before screening
- 6 or more migraine days during the Observation Period
- 14 or fewer headache days during the Observation Period
- Pediatric Migraine Disability Assessment Scale (PedMIDAS) score greater than 10 and up to 50 indicating mild or moderate daily activity disruption
- Ability to verbally distinguish migraine attacks from other types of headaches
- Migraine attacks lasting 4 to 72 hours if untreated
- Stable dose of prophylactic migraine medication for at least 3 months prior to screening is allowed
- Age 6 to under 18 years at the time of consent/assent
- Weight of at least 40 kg (child cohort at least 15 kg) 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 condition for at least 6 months prior to screening
- Lifetime history of psychosis or mania
- History of suicidal behavior or risk of self-harm or harm to others
- History of major psychiatric disorder
- Current diagnosis or history of substance abuse
- History of moderate or severe head trauma, neurological disorder, or systemic disease affecting central nervous system function
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 90 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
Accel Research Sites Network - Edgewater Clinical Research Unit
Edgewater, Florida, United States, 32132
Active, Not Recruiting
8
Direct Helpers Research Center
Hialeah, Florida, United States, 33012
Actively Recruiting
9
New Med Research, Inc
Hollywood, Florida, United States, 33020
Terminated
10
Complete Health Research
Ormond Beach, Florida, United States, 32174
Active, Not Recruiting
11
D&H Tamarac Research Center LLC
Tamarac, Florida, United States, 33321
Actively Recruiting
12
Santos Research Center, CORP
Tampa, Florida, United States, 33615
Actively Recruiting
13
Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
14
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, United States, 30328
Active, Not Recruiting
15
Meridian Clinical Research, LLC
Savannah, Georgia, United States, 31406
Active, Not Recruiting
16
Extraordinary Family Healthcare
Snellville, Georgia, United States, 30078
Active, Not Recruiting
17
Renew Health Clinical Research LLC
Snellville, Georgia, United States, 30078
Active, Not Recruiting
18
Northwest Clinical Trials, Inc.
Boise, Idaho, United States, 83704
Actively Recruiting
19
Diamond Headache Clinic
Chicago, Illinois, United States, 60642
Terminated
20
Nola Research Works, LLC
New Orleans, Louisiana, United States, 70125
Actively Recruiting
21
Safe Haven Clinical Research
Clinton, Mississippi, United States, 39056
Actively Recruiting
22
Roy Blunt NextGen Precision Health Building
Columbia, Missouri, United States, 65211
Actively Recruiting
23
University of Missouri Health Care - Investigation Pharmacy
Columbia, Missouri, United States, 65212
Actively Recruiting
24
University of Missouri-Clinical and Translational Sciences Unit
Columbia, Missouri, United States, 65212
Actively Recruiting
25
University of Missouri
Columbia, Missouri, United States, 65212
Actively Recruiting
26
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, United States, 68803
Actively Recruiting
27
Papillion Research Center/CCT Research
Papillion, Nebraska, United States, 68046
Actively Recruiting
28
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Active, Not Recruiting
29
Dent Neurosciences Research Center, Inc.
Amherst, New York, United States, 14226
Active, Not Recruiting
30
Montefiore Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
31
Carolina Institute for Clinical Research, LLC
Fayetteville, North Carolina, United States, 28303
Active, Not Recruiting
32
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
33
Velocity Clinical Research
Cincinnati, Ohio, United States, 45242
Active, Not Recruiting
34
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States, 73112
Active, Not Recruiting
35
Coastal Pediatric Research
Charleston, South Carolina, United States, 29414
Active, Not Recruiting
36
Tribe Clinical Research LLC
Greenville, South Carolina, United States, 29607
Terminated
37
Avera McKennan Hospital & University Health Center
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
38
Avera Research Institute
Sioux Falls, South Dakota, United States, 57108
Actively Recruiting
39
Avera Medical Group Pediatrics - Dawley Farm
Sioux Falls, South Dakota, United States, 57110
Actively Recruiting
40
Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, United States, 37232
Terminated
41
Alina Clinical Trials, LLC.
Dallas, Texas, United States, 75209
Actively Recruiting
42
North Texas Center for Clinical Research
Frisco, Texas, United States, 75034
Actively Recruiting
43
DM Clinical Research - Cy Fair
Houston, Texas, United States, 77065
Actively Recruiting
44
SCLA Management - Drop Box
Houston, Texas, United States, 77077
Actively Recruiting
45
SCLA Management Office
Houston, Texas, United States, 77077
Actively Recruiting
46
NeuroCare Plus
Houston, Texas, United States, 77094
Actively Recruiting
47
Red Star Research, LLC
Lake Jackson, Texas, United States, 77566
Active, Not Recruiting
48
DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials
McAllen, Texas, United States, 78503
Actively Recruiting
49
DCT-Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, United States, 78258
Actively Recruiting
50
Texas Institute for Neurological Disorders
Sherman, Texas, United States, 75092
Active, Not Recruiting
51
DM Clinical Research (Administrative Office Only)
Tomball, Texas, United States, 77375
Actively Recruiting
52
Victoria Clinical Research Group
Victoria, Texas, United States, 77901
Terminated
53
Meridian Clinical Research, LLC
Portsmouth, Virginia, United States, 23703
Active, Not Recruiting
54
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada, V6H 3V4
Terminated
55
Centre Hospitalier Intercommunal de Créteil
Créteil, France, 94000
Actively Recruiting
56
Centre Hospitalier Universitaire de Montpellier
Montpellier, France, 34295
Active, Not Recruiting
57
Hopital des Enfants
Toulouse, France, 31059
Actively Recruiting
58
UOSVD Centro Epilessia ed EEG dellEta Evolutiva
Bari, BARI / Puglia, Italy, 70132
Actively Recruiting
59
Sapienza Universita di Roma Polo Pontino - ICOT, Headache clinic
Latina, Latina/lazio, Italy, 04100
Actively Recruiting
60
IRCCS San Raffaele
Rome, Lazio, Italy, 00166
Actively Recruiting
61
Istituto Neurologico "Carlo Besta" Fondazione IRCCS
Milan, Lombardy, Italy, 20133
Actively Recruiting
62
Divisione di Neurologia, Ospedale Pediatrico Bambino Gesu
Rome, Rome/lazio, Italy, 00165
Actively Recruiting
63
ASST Spedali Civili di Brescia
Brescia, Italy, 25069
Actively Recruiting
64
Jinnouchi Neurosurgical Clinic
Kasuga-shi, Fukuoka, Japan, 816-0802
Actively Recruiting
65
Hikita Pediatric Clinic
Kiryu-shi, Gunma, Japan, 376-0035
Actively Recruiting
66
Konan Medical Center
Higashinada-ku Kobe-shi, Hyōgo, Japan, 658-0064
Actively Recruiting
67
Yamaguchi Clinic
Nishinomiya-shi, Hyōgo, Japan, 663-8204
Actively Recruiting
68
Mito Kyodo General Hospital
Mito, Ibaraki, Japan, 310-0015
Not Yet Recruiting
69
Tanaka Neurosurgery & Headache Clinic
Kagoshima, Kagoshima-ken, Japan, 890-0052
Actively Recruiting
70
Atago Hospital
Kochi, Kochi, Japan, 780-0051
Actively Recruiting
71
Sendai Headache and Neurology Clinic
Taihaku-ku Sendai-shi, Miyagi, Japan, 982-0014
Actively Recruiting
72
Tennouji Dai Brain Clinic
Abeno-ku Osaka-shi, Osaka, Japan, 545-0053
Actively Recruiting
73
Tominaga Clinic
Naniwa-ku, Osaka, Japan, 556-0015
Actively Recruiting
74
Saitama Neuropsychiatric Institute
Chuo-ku Saitama-shi, Saitama, Japan, 338-8577
Actively Recruiting
75
Tokyo Headache Clinic
Shibuya-ku, Tokyo, Japan, 151-0051
Actively Recruiting
76
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan, 160-0023
Actively Recruiting
77
Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.
Poznan, Greater Poland Voivodeship, Poland, 61-731
Actively Recruiting
78
Wojewodzki Specjalistyczny Szpital Dzieciecy
Krakow, Lesser Poland Voivodeship, Poland, 31-503
Actively Recruiting
79
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw, Lower Silesian Voivodeship, Poland, 52-210
Actively Recruiting
80
NZOZ Neuromed M. i M. Nastaj Sp. P.
Lublin, Lublin Voivodeship, Poland, 20-064
Actively Recruiting
81
MTZ Clinical Research Powered by Pratia
Warsaw, Masovian Voivodeship, Poland, 02-172
Actively Recruiting
82
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
Katowice, Silesian Voivodeship, Poland, 40-123
Active, Not Recruiting
83
Neurologia Slaska Centrum Medyczne
Katowice, Silesian Voivodeship, Poland, 40-689
Actively Recruiting
84
Next Stage Sp. Z o.o.
Warsaw, WOJ. Mazowieckie, Poland, 02-121
Actively Recruiting
85
Hospital Universitari Parc Tauli
Sabadell, Barcelona, Spain, 08208
Actively Recruiting
86
Hospital Clinico Universitario de Valladolid (HCUV)
Valladolid, Castille and León, Spain, 47003
Actively Recruiting
87
Hospital Alvaro Cunqueiro
Vigo, Galicia, Spain, 36312
Actively Recruiting
88
Instituto de Investigaciones del Sueno
Madrid, Spain, 28036
Actively Recruiting
89
Virgen del Rocio Hospital
Seville, Spain, 41013
Actively Recruiting
90
Hospital Universitario y Politecnico La Fe
Valencia, Spain, 46026
Actively Recruiting
Research Team
P
Pfizer Pfizer CT.gov Call Center
CONTACT
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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