search
Back to results

Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine

Primary Purpose

Acute Treatment of Migraine

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rimegepant / BHV3000
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Treatment of Migraine focused on measuring Long-term safety, acute treatment, migraine, phonophobia, photophobia, nausea, pediatric, children, adolescent

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. History of migraine (with or without aura) for ≥ 6 months before Screening
  2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment.
  3. 1 or more migraine days requiring treatment during the Observation Phase.
  4. Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit
  5. Ability to distinguish between migraine and other types of headaches.
  6. Weight ≥ 40 kg at the Screening Visit.
  7. Adequate venous access for blood sampling.
  8. Male and female participants ≥ 6 to < 18 years of age (participants must not reach their 18th birthday before enrollment into the study)

Exclusion Criteria:

  1. History of cluster headache or hemiplegic migraine headache.
  2. Confounding and clinically significant pain syndrome
  3. Current uncontrolled and/or untreated psychiatric condition for a minimum of 6 months prior to the Screening Visit (lifetime history of psychosis and/or mania are excluded).
  4. History of suicidal behavior or major psychiatric disorder.
  5. Current diagnosis or history of substance abuse; positive drug test at Screening.

Sites / Locations

  • Perseverance Research Center, LLCRecruiting
  • Physicians Research GroupRecruiting
  • Advanced Research Center, Inc.Recruiting
  • Velocity Clinical Research- BanningRecruiting
  • The Neuron ClinicRecruiting
  • ProScience Research GroupRecruiting
  • Neuro-Pain Medical CenterRecruiting
  • Sunwise Clinical ResearchRecruiting
  • Children's Hospital Los Angeles - Children's Hospital Los Angeles Dept of Pharmacy
  • Children's Hospital Los Angeles, Division of Neurology
  • National Research InstituteRecruiting
  • Velocity Clinical Research - North HollywoodRecruiting
  • The Neurology GroupRecruiting
  • UC Davis Medical Center, Investigational Drug Service (IDS) PharmacyRecruiting
  • UC DavisRecruiting
  • University of California, Davis Clinical and Translational Science Center Clinical Research CenterRecruiting
  • University of California, Davis Midtown ClinicRecruiting
  • Pacific Clinical Research Management Group LLCRecruiting
  • Children's Hospital Colorado Investigational Drug ServicesRecruiting
  • Children's Hospital Colorado- Investigational Drug ServicesRecruiting
  • Children's Hospital ColoradoRecruiting
  • Colorado Springs Neurological AssociatesRecruiting
  • Boeson Research GJT
  • Dinosaur PediatricsRecruiting
  • Dinosaur Pediatrics
  • Boeson Research - Grand Junction, CORecruiting
  • Boeson Research GJT
  • CT Clinical ResearchRecruiting
  • Connecticut Children's Medical CenterRecruiting
  • Ki Health Partners, LLc, dba New England Institute for Clinical ResearchRecruiting
  • Sarkis Clinical TrialsRecruiting
  • Multi-Specialty Research Associates, Inc.Recruiting
  • South Florida Research Phase I-IV, IncRecruiting
  • AppleMed Research Group, LLCRecruiting
  • Medical Research Center of Miami II, Inc
  • Brainstorm ResearchRecruiting
  • Coastal Clinical Research SpecialistsRecruiting
  • Orlando Health Arnold Palmer Hospital for Children-Pediatric Specialty Practice
  • Orlando Health Arnold Palmer Hospital for Children
  • ForCare Clinical ResearchRecruiting
  • Premiere Research Institute at Palm Beach NeurologyRecruiting
  • Children's Healthcare of Atlanta - Center for Advanced PediatricsRecruiting
  • Rare Disease Research LLCRecruiting
  • Pivotal Clinical Research & Associates, LLCRecruiting
  • CenExel iResearch, LLCRecruiting
  • Chicago Headache Center & Research InstituteRecruiting
  • Children's Clinical Research Center at Riley Hospital for Children at IU HealthRecruiting
  • Riley Hospital for Children at IU HealthRecruiting
  • Physicians Research Group (Administrative Office Location)Recruiting
  • College Park Family Care Center Physician Service Group - Neruology Research DepartmentRecruiting
  • University of Kentucky HospitalRecruiting
  • Ochsner Clinic FoundationRecruiting
  • Boston Clinical TrialsRecruiting
  • MedVadis ResearchRecruiting
  • Michigan Head Pain and Neurological InstituteRecruiting
  • Outpatient Pediatric Neurology ClinicRecruiting
  • Wellnow Urgent Care and Research
  • Beaumont Hospital, Royal Oak CampusRecruiting
  • Sharlin Health Neuroscience Research CenterRecruiting
  • Clinvest Research, LLCRecruiting
  • Clinvest Research, LLCRecruiting
  • Boeson ResearchRecruiting
  • Northwest PhysiciansRecruiting
  • Boeson Research (HLN)Recruiting
  • Boeson Research,LLCRecruiting
  • Boeson ResearchRecruiting
  • Alivation Research, LLC
  • Dent Neurosciences Research CenterRecruiting
  • New York Neurology AssociatesRecruiting
  • Mount Sinai Hospital - Pharmacy Department
  • Mount Sinai Hospital - Pharmacy DepartmentRecruiting
  • Columbia University Medical Center Research PharmacyRecruiting
  • Columbia University Pediatric Neuromuscular CenterRecruiting
  • Irving Center for Clinical and Translational Research, Outpatient Clinical Research UnitRecruiting
  • The Neurological Institute of New YorkRecruiting
  • North Suffolk NeurologyRecruiting
  • Headache Wellness Center, PCRecruiting
  • Headache Wellness CenterRecruiting
  • WellNow Urgent Care and ResearchRecruiting
  • Cincinnati Children's HospitalRecruiting
  • Drug Delivery-Cincinnati Children's IDS Denise LagoryRecruiting
  • Velocity Clinical Research - CincinnatiRecruiting
  • University Hospitals Cleveland Medical CenterRecruiting
  • Wellnow Urgent Care and ResearchRecruiting
  • Wellnow Urgent Care and ResearchRecruiting
  • Wellnow Urgent Care and ResearchRecruiting
  • IPS Research Company
  • Velocity Clinical Research, Grants PassRecruiting
  • Providence Portland Medical CenterRecruiting
  • Providence Health & Services Investigational Drug Services WestsideRecruiting
  • Providence St. Vincent Medical CenterRecruiting
  • Children's Hospital of PhiladelphiaRecruiting
  • Velocity Clinical Research-ProvidenceRecruiting
  • Tribe Clinical Research LLCRecruiting
  • Velocity Clinical Research- GreenvilleRecruiting
  • Premier Neurology
  • Coastal Carolina Research CenterRecruiting
  • Novaceut Clinical ResearchRecruiting
  • Le Bonheur Children's HospitalRecruiting
  • Le Bonheur Childrens Hospital - Childrens Foundation Research InstituteRecruiting
  • Le Bonheur Childrens Hospital - Outpatient BuildingRecruiting
  • Access Clinical Trials, Inc.Recruiting
  • Dell Children's Medical Center
  • Child Neurology Consultants of Austin - South AustinRecruiting
  • Child Neurology Consultants of Austin - Central AustinRecruiting
  • Houston Clinical Trials, LLCRecruiting
  • Cedar Health ResearchRecruiting
  • ANRC ResearchRecruiting
  • North Texas Institute of Neurology and HeadacheRecruiting
  • North Texas Institute of Neurology and Headache
  • Trio Clinical Trials, LLC.Recruiting
  • Pain and Headache Centers of TexasRecruiting
  • SCLA ManagementRecruiting
  • Houston Clinical Research,LLC.
  • AIM Trials, LLCRecruiting
  • JBR Clinical ResearchRecruiting
  • Wasatch Clinical Research , LLC(Administrative Location)Recruiting
  • Children's Hospital of The King's DaughtersRecruiting
  • Children's Specialty Group, PLLC , Division of Childhood & Adolescent NeurologyRecruiting
  • National Clinical Research, Inc.Recruiting
  • Northwest Clinical Research CenterRecruiting
  • Eastside Therapeutic Resource, Inc. dba Core Clinical ResearchRecruiting
  • Seattle Children's Hospital Investigational Drug Services
  • Seattle Children's Hospital
  • University HospitalRecruiting
  • University of Wisconsin-MadisonRecruiting
  • Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Oddzial Kliniczny DzieciRecruiting
  • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech SzczechowskiRecruiting
  • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech SzczechowskiRecruiting
  • Centrum Medyczne PlejadyRecruiting
  • Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Oddzial Kliniczny DzieciRecruiting
  • Clinical Research Center Sp. z o.o.Recruiting
  • Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.kRecruiting
  • Euromedis Sp. z o.o. Osrodek BRecruiting
  • Pracownia Badan Klinicznych SALUSRecruiting
  • Centrum Medyczne OporowRecruiting
  • Centre Atencio Primaria (CAP) Balenya
  • Hospital Universitario Marques de ValdecillaRecruiting
  • Hospital Universitari Vall dHebronRecruiting
  • CAP Balenyà
  • Instituto de Investigaciones del SuenoRecruiting
  • Hospital Universitario Marques de ValdecillaRecruiting
  • Hospital Universitario Virgen del Rocio (HUVR)Recruiting
  • Hospital Clinico Universitario de ValladolidRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rimegepant / BHV3000

Arm Description

BHV3000 (rimegepant) 75 mg or 50 mg ODT

Outcomes

Primary Outcome Measures

The occurrence of treatment-emergent adverse events, serious adverse events
To evaluate the safety and tolerability of rimegepant in children and adolescents (≥ 6 to < 18 years of age).

Secondary Outcome Measures

Full Information

First Posted
February 4, 2021
Last Updated
October 10, 2023
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT04743141
Brief Title
Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
Official Title
Phase 3, Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Rimegepant for the Acute Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of moderate or severe migraine in children and adolescents (≥ 6 to < 18 years of age).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Treatment of Migraine
Keywords
Long-term safety, acute treatment, migraine, phonophobia, photophobia, nausea, pediatric, children, adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rimegepant / BHV3000
Arm Type
Experimental
Arm Description
BHV3000 (rimegepant) 75 mg or 50 mg ODT
Intervention Type
Drug
Intervention Name(s)
Rimegepant / BHV3000
Intervention Description
BHV3000 (rimegepant) 75 mg or 50 mg ODT
Primary Outcome Measure Information:
Title
The occurrence of treatment-emergent adverse events, serious adverse events
Description
To evaluate the safety and tolerability of rimegepant in children and adolescents (≥ 6 to < 18 years of age).
Time Frame
58 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of migraine (with or without aura) for ≥ 6 months before Screening History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment. 1 or more migraine days requiring treatment during the Observation Phase. Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit Ability to distinguish between migraine and other types of headaches. Weight ≥ 40 kg at the Screening Visit. Adequate venous access for blood sampling. Male and female participants ≥ 6 to < 18 years of age (participants must not reach their 18th birthday before enrollment into the study) Exclusion Criteria: History of cluster headache or hemiplegic migraine headache. Confounding and clinically significant pain syndrome Current uncontrolled and/or untreated psychiatric condition for a minimum of 6 months prior to the Screening Visit (lifetime history of psychosis and/or mania are excluded). History of suicidal behavior or major psychiatric disorder. Current diagnosis or history of substance abuse; positive drug test at Screening.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Perseverance Research Center, LLC
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Individual Site Status
Recruiting
Facility Name
Physicians Research Group
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Research Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research- Banning
City
Banning
State/Province
California
ZIP/Postal Code
92220
Country
United States
Individual Site Status
Recruiting
Facility Name
The Neuron Clinic
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Individual Site Status
Recruiting
Facility Name
ProScience Research Group
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Individual Site Status
Recruiting
Facility Name
Neuro-Pain Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Individual Site Status
Recruiting
Facility Name
Sunwise Clinical Research
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital Los Angeles - Children's Hospital Los Angeles Dept of Pharmacy
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Children's Hospital Los Angeles, Division of Neurology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research - North Hollywood
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Individual Site Status
Recruiting
Facility Name
The Neurology Group
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Individual Site Status
Recruiting
Facility Name
UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Name
UC Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, Davis Clinical and Translational Science Center Clinical Research Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, Davis Midtown Clinic
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Recruiting
Facility Name
Pacific Clinical Research Management Group LLC
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital Colorado Investigational Drug Services
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital Colorado- Investigational Drug Services
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Colorado Springs Neurological Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Recruiting
Facility Name
Boeson Research GJT
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Individual Site Status
Terminated
Facility Name
Dinosaur Pediatrics
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Individual Site Status
Recruiting
Facility Name
Dinosaur Pediatrics
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81501
Country
United States
Individual Site Status
Terminated
Facility Name
Boeson Research - Grand Junction, CO
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81505
Country
United States
Individual Site Status
Recruiting
Facility Name
Boeson Research GJT
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81505
Country
United States
Individual Site Status
Terminated
Facility Name
CT Clinical Research
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Individual Site Status
Recruiting
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Recruiting
Facility Name
Ki Health Partners, LLc, dba New England Institute for Clinical Research
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Individual Site Status
Recruiting
Facility Name
Multi-Specialty Research Associates, Inc.
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Individual Site Status
Recruiting
Facility Name
South Florida Research Phase I-IV, Inc
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Individual Site Status
Recruiting
Facility Name
AppleMed Research Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Research Center of Miami II, Inc
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Brainstorm Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
Coastal Clinical Research Specialists
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Individual Site Status
Recruiting
Facility Name
Orlando Health Arnold Palmer Hospital for Children-Pediatric Specialty Practice
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Orlando Health Arnold Palmer Hospital for Children
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Name
Premiere Research Institute at Palm Beach Neurology
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Name
Rare Disease Research LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Name
Pivotal Clinical Research & Associates, LLC
City
Brunswick
State/Province
Georgia
ZIP/Postal Code
31520
Country
United States
Individual Site Status
Recruiting
Facility Name
CenExel iResearch, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Name
Chicago Headache Center & Research Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Clinical Research Center at Riley Hospital for Children at IU Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
Riley Hospital for Children at IU Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
Physicians Research Group (Administrative Office Location)
City
Noblesville
State/Province
Indiana
ZIP/Postal Code
46060
Country
United States
Individual Site Status
Recruiting
Facility Name
College Park Family Care Center Physician Service Group - Neruology Research Department
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kentucky Hospital
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Individual Site Status
Recruiting
Facility Name
MedVadis Research
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Individual Site Status
Recruiting
Facility Name
Michigan Head Pain and Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Individual Site Status
Recruiting
Facility Name
Outpatient Pediatric Neurology Clinic
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Individual Site Status
Recruiting
Facility Name
Wellnow Urgent Care and Research
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Individual Site Status
Terminated
Facility Name
Beaumont Hospital, Royal Oak Campus
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Individual Site Status
Recruiting
Facility Name
Sharlin Health Neuroscience Research Center
City
Ozark
State/Province
Missouri
ZIP/Postal Code
65721
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinvest Research, LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinvest Research, LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65810
Country
United States
Individual Site Status
Recruiting
Facility Name
Boeson Research
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Physicians
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Individual Site Status
Recruiting
Facility Name
Boeson Research (HLN)
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Individual Site Status
Recruiting
Facility Name
Boeson Research,LLC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Individual Site Status
Recruiting
Facility Name
Boeson Research
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Individual Site Status
Recruiting
Facility Name
Alivation Research, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Individual Site Status
Terminated
Facility Name
Dent Neurosciences Research Center
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Individual Site Status
Recruiting
Facility Name
New York Neurology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Individual Site Status
Recruiting
Facility Name
Mount Sinai Hospital - Pharmacy Department
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Mount Sinai Hospital - Pharmacy Department
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University Medical Center Research Pharmacy
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University Pediatric Neuromuscular Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Irving Center for Clinical and Translational Research, Outpatient Clinical Research Unit
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
The Neurological Institute of New York
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
North Suffolk Neurology
City
Port Jefferson Station
State/Province
New York
ZIP/Postal Code
11776
Country
United States
Individual Site Status
Recruiting
Facility Name
Headache Wellness Center, PC
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Individual Site Status
Recruiting
Facility Name
Headache Wellness Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Individual Site Status
Recruiting
Facility Name
WellNow Urgent Care and Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Individual Site Status
Recruiting
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Name
Drug Delivery-Cincinnati Children's IDS Denise Lagory
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Wellnow Urgent Care and Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Individual Site Status
Recruiting
Facility Name
Wellnow Urgent Care and Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43228
Country
United States
Individual Site Status
Recruiting
Facility Name
Wellnow Urgent Care and Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45424
Country
United States
Individual Site Status
Recruiting
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73106
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Velocity Clinical Research, Grants Pass
City
Grants Pass
State/Province
Oregon
ZIP/Postal Code
97527
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Health & Services Investigational Drug Services Westside
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research-Providence
City
East Greenwich
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Individual Site Status
Recruiting
Facility Name
Tribe Clinical Research LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research- Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Individual Site Status
Recruiting
Facility Name
Premier Neurology
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Coastal Carolina Research Center
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29405
Country
United States
Individual Site Status
Recruiting
Facility Name
Novaceut Clinical Research
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37043
Country
United States
Individual Site Status
Recruiting
Facility Name
Le Bonheur Children's Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Individual Site Status
Recruiting
Facility Name
Le Bonheur Childrens Hospital - Childrens Foundation Research Institute
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Individual Site Status
Recruiting
Facility Name
Le Bonheur Childrens Hospital - Outpatient Building
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Individual Site Status
Recruiting
Facility Name
Access Clinical Trials, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Dell Children's Medical Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Child Neurology Consultants of Austin - South Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78749
Country
United States
Individual Site Status
Recruiting
Facility Name
Child Neurology Consultants of Austin - Central Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Individual Site Status
Recruiting
Facility Name
Houston Clinical Trials, LLC
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Name
Cedar Health Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Individual Site Status
Recruiting
Facility Name
ANRC Research
City
El Paso
State/Province
Texas
ZIP/Postal Code
79912
Country
United States
Individual Site Status
Recruiting
Facility Name
North Texas Institute of Neurology and Headache
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Individual Site Status
Recruiting
Facility Name
North Texas Institute of Neurology and Headache
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Trio Clinical Trials, LLC.
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Individual Site Status
Recruiting
Facility Name
Pain and Headache Centers of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting
Facility Name
SCLA Management
City
Houston
State/Province
Texas
ZIP/Postal Code
77079
Country
United States
Individual Site Status
Recruiting
Facility Name
Houston Clinical Research,LLC.
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
AIM Trials, LLC
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Name
JBR Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
Wasatch Clinical Research , LLC(Administrative Location)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital of The King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Specialty Group, PLLC , Division of Childhood & Adolescent Neurology
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States
Individual Site Status
Recruiting
Facility Name
National Clinical Research, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Individual Site Status
Recruiting
Facility Name
Eastside Therapeutic Resource, Inc. dba Core Clinical Research
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Individual Site Status
Recruiting
Facility Name
Seattle Children's Hospital Investigational Drug Services
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Name
Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Oddzial Kliniczny Dzieci
City
Karkow
ZIP/Postal Code
31-503
Country
Poland
Individual Site Status
Recruiting
Facility Name
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
City
Katowice
ZIP/Postal Code
10-123
Country
Poland
Individual Site Status
Recruiting
Facility Name
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
City
Katowice
ZIP/Postal Code
40-123
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Plejady
City
Krakow
ZIP/Postal Code
30-363
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Oddzial Kliniczny Dzieci
City
Krakow
ZIP/Postal Code
31-503
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Research Center Sp. z o.o.
City
Poznań
ZIP/Postal Code
60-848
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k
City
Poznań
ZIP/Postal Code
61-731
Country
Poland
Individual Site Status
Recruiting
Facility Name
Euromedis Sp. z o.o. Osrodek B
City
Szczecin,
ZIP/Postal Code
70-111,
Country
Poland
Individual Site Status
Recruiting
Facility Name
Pracownia Badan Klinicznych SALUS
City
Wroclaw
ZIP/Postal Code
52-210
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Oporow
City
Wroclaw
ZIP/Postal Code
52-416
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centre Atencio Primaria (CAP) Balenya
City
Balenya
State/Province
Barcelona
ZIP/Postal Code
08550
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall dHebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
CAP Balenyà
City
Barcelona
ZIP/Postal Code
08550
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Instituto de Investigaciones del Sueno
City
Madrid
ZIP/Postal Code
28036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocio (HUVR)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=BHV3000-312
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine

We'll reach out to this number within 24 hrs