Back to resultsEfficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
Primary Purpose
Migraine
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rimegepant
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Migraine focused on measuring Migraine, Migraine prevention, Phonophobia, Photophobia, Nausea, Pediatric migraine, Adolescent migraine
Eligibility Criteria
Inclusion Criteria:
Subject has at least a 6 month history of migraine (with or without aura) and including the following:
- 14 or less headache days per month during the 3 month period prior to the Screening Visit
- 6 or more migraine days during the Observation Period
- 14 or less headache days during the Observation Period
- Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of >10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline (Randomization) Visit
- Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
- Migraine attacks, on average, lasting 4 - 72 hours if untreated
Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the course of the study. 2) Male and female subjects ≥ 6 to <18 years; subjects must be less than 18 at the time of signing assent / consent.
3)Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the Screening Visit.
Exclusion Criteria:
- Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine
- The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
- The subject has a history or diagnosis of complications of migraine
- The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.
- The subject has any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Subjects with a lifetime history of psychosis and/or mania are excluded.
- History of suicidal behavior or the subject is at risk of self-harm or harm to others.
- History of major psychiatric disorder.
- The subject has a current diagnosis or history of substance abuse
- The subject has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator's opinion, likely to affect central nervous system functioning.
Sites / Locations
- The Belinga ClinicRecruiting
- Advanced Investigative Medicine, Inc.Recruiting
- Velocity Clinical Research San DiegoRecruiting
- Clinical Research of CaliforniaRecruiting
- Colorado Springs Neurological Associates
- Advanced Neurosciences Research, LLCRecruiting
- Meridian Clinical Research, LLCRecruiting
- Synergy HealthcareRecruiting
- Vertex Research GroupRecruiting
- Complete Health ResearchRecruiting
- Direct Helpers Research CenterRecruiting
- New Med Research, IncRecruiting
- Axcess Medical ResearchRecruiting
- Sanitas Research, LLCRecruiting
- APG Research, LLCRecruiting
- Complete Health ResearchRecruiting
- D&H Tamarac Research Center LLCRecruiting
- Santos Research Center, CORPRecruiting
- WR-Mount Vernon Clinical Research, LLCRecruiting
- Meridian Clinical Research, LLCRecruiting
- Extraordinary Family HealthcareRecruiting
- Renew Health Clinical Research LLCRecruiting
- Northwest Clinical Trials, Inc.Recruiting
- Diamond Headache Clinic
- Safe Haven Clinical ResearchRecruiting
- University of Missouri Health Care - Clinical Research CenterRecruiting
- University of Missouri Health Care - Investigation Pharmacy (IP to be shipped here)Recruiting
- University of Missouri Health Care - Pathology DepartmentRecruiting
- University of Missouri School of MedicineRecruiting
- Meridian Clinical Research, LLCRecruiting
- Midwest Children's Health Research Institute, LLCRecruiting
- Papillion Research Center/CCT ResearchRecruiting
- Renown Regional Medical CenterRecruiting
- Ocean Medical ResearchRecruiting
- Albuquerque Neuroscience Inc.Recruiting
- Dent Neurosciences Research Center, Inc.Recruiting
- Montefiore Medical CenterRecruiting
- Carolina Institute for Clinical Research, LLCRecruiting
- Cincinnati Children's Hospital Medical CenterRecruiting
- Velocity Clinical ResearchRecruiting
- Lynn Health Science InstituteRecruiting
- Meridian Clinical Research, LLCRecruiting
- Coastal Pediatric ResearchRecruiting
- Tribe Clinical Research LLCRecruiting
- Avera McKennan Hospital & University Health CenterRecruiting
- Avera Medical Group Pediatric SpecialistsRecruiting
- Avera Research InstituteRecruiting
- Monroe Carell Jr Children's Hospital at VanderbiltRecruiting
- DCT-Baxter Research, LLC dba Discovery Clinical TrialsRecruiting
- DM Clinical Research - Cy FairRecruiting
- SCLA ManagementRecruiting
- Red Star Research, LLCRecruiting
- DCT-McAllen Primary Care Research, LLC dba Discovery Clinical TrialsRecruiting
- DCT-Stone Oak, LLC dba Discovery Clinical TrialsRecruiting
- Texas Institute for Neurological DisordersRecruiting
- DM Clinical Research (Administrative Office Only)Recruiting
- Victoria Clinical Research GroupRecruiting
- South Ogden Family Medicine Ogden Clinic/CCT ResearchRecruiting
- Meridian Clinical Research, LLCRecruiting
- The Kids ClinicRecruiting
- Children's Hospital of Eastern Ontario
- Centre Hospitalier Intercommunal de Créteil
- Hopital des Enfants
- Unita di Neurologia, Azienda Ospedaliera San Giuseppe Moscati
- Spaienza Universita di Roma Polo Pontino - ICOT, Headache clinic
- U.O. di Neurologia- ASST Spedali Civili di Brescia
- Fondazione Mondino - Istituto Neurologico Nazionale IRCCS
- IRCCS San Raffaele Roma
- MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
- Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej
- NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
- Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.
- Wojewodzki Specjalistyczny Szpital Dzieciecy im. sw. Ludwika w Krakowie
- NZOZ Neuromed M. i M. Nastaj Sp. P.
- MTZ Clinical Research Sp. z o.o.Recruiting
- Hospital Universitari Parc TauliRecruiting
- Hospital Clinico Universitario de Valladolid (HCUV)Recruiting
- Hospital Alvaro CunqueiroRecruiting
- Hospital Clinico Universitario de Santiago de Compostela
- Virgen del Rocio HospitalRecruiting
- Hospital Universitario y Politecnico La FeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Rimegepant / BHV3000
Matching Placebo
Arm Description
Rimegepant 75mg or 50mg (2 X 25mg) ODT
Matching placebo 75mg or 50mg (2 X 25mg) ODT
Outcomes
Primary Outcome Measures
Change from baseline in the mean number of migraine days per month as measured over the 12-week double-blind phase of the study in adolescents with episodic migraine
Reduction from baseline in mean number of migraine days per month
Secondary Outcome Measures
Achievement of at least a 50% reduction from baseline in mean monthly migraine days over the course of the double-blind phase in adolescents with episodic migraine
Change from baseline in the mean number of migraine days per month in the first 4 weeks (Weeks 1 through 4) of the double-blind treatment phase in adolescents with episodic migraine.
The mean change from baseline in the Pediatric Quality of Life (PedsQL™) total score at Week 12 of the double-blind treatment phase in adolescents with episodic migraine.
Change from baseline in the mean number of migraine days per month over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine.
Change from baseline on the proportion of subjects that have at least a 50% reduction in the mean number of moderate to severe migraine days per month.
Measured over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine.
Compare the use of acute migraine-specific medications (triptans) based on the change from baseline in monthly acute migraine specific medication days.
Measured in each month and over the course of the entire double-blind treatment phase in adolescents, children and adolescents and children combined.
Evaluate the safety and tolerability of rimegepant as a preventative treatment for migraine in children and adolescents.
This will be evaluated by the number of subjects with treatment related adverse events by severity.
Evaluate the frequency of hepatic-related adverse events in subjects treated with rimegepant.
Measured by discontinuations in treated subjects due to elevated liver function tests.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05156398
Brief Title
Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents ≥ 6 to <18 Years of Age
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2022 (Actual)
Primary Completion Date
April 29, 2027 (Anticipated)
Study Completion Date
April 29, 2027 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Migraine prevention, Phonophobia, Photophobia, Nausea, Pediatric migraine, Adolescent migraine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
640 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Rimegepant / BHV3000
Arm Type
Active Comparator
Arm Description
Rimegepant 75mg or 50mg (2 X 25mg) ODT
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo 75mg or 50mg (2 X 25mg) ODT
Intervention Type
Drug
Intervention Name(s)
Rimegepant
Other Intervention Name(s)
BHV3000
Intervention Description
Rimegepant 75mg or 50mg (2 X 25mg) ODT
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Matching Placebo
Intervention Description
Matching placebo 75mg or 50mg (2 X 25mg) ODT
Primary Outcome Measure Information:
Title
Change from baseline in the mean number of migraine days per month as measured over the 12-week double-blind phase of the study in adolescents with episodic migraine
Description
Reduction from baseline in mean number of migraine days per month
Time Frame
3 months (12 weeks)
Secondary Outcome Measure Information:
Title
Achievement of at least a 50% reduction from baseline in mean monthly migraine days over the course of the double-blind phase in adolescents with episodic migraine
Time Frame
3 months (12 weeks)
Title
Change from baseline in the mean number of migraine days per month in the first 4 weeks (Weeks 1 through 4) of the double-blind treatment phase in adolescents with episodic migraine.
Time Frame
Weeks 1 through 4 of treatment
Title
The mean change from baseline in the Pediatric Quality of Life (PedsQL™) total score at Week 12 of the double-blind treatment phase in adolescents with episodic migraine.
Time Frame
Total score at week 12
Title
Change from baseline in the mean number of migraine days per month over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine.
Time Frame
3 months (12 weeks)
Title
Change from baseline on the proportion of subjects that have at least a 50% reduction in the mean number of moderate to severe migraine days per month.
Description
Measured over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine.
Time Frame
3 months (12 weeks)
Title
Compare the use of acute migraine-specific medications (triptans) based on the change from baseline in monthly acute migraine specific medication days.
Description
Measured in each month and over the course of the entire double-blind treatment phase in adolescents, children and adolescents and children combined.
Time Frame
3 months (12 weeks)
Title
Evaluate the safety and tolerability of rimegepant as a preventative treatment for migraine in children and adolescents.
Description
This will be evaluated by the number of subjects with treatment related adverse events by severity.
Time Frame
72 Weeks
Title
Evaluate the frequency of hepatic-related adverse events in subjects treated with rimegepant.
Description
Measured by discontinuations in treated subjects due to elevated liver function tests.
Time Frame
72 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:
Subject has at least a 6 month history of migraine (with or without aura) and including the following:
14 or less headache days per month during the 3 month period prior to the Screening Visit
6 or more migraine days during the Observation Period
14 or less headache days during the Observation Period
Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of >10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline (Randomization) Visit
Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
Migraine attacks, on average, lasting 4 - 72 hours if untreated
Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the course of the study. 2) Male and female subjects ≥ 6 to <18 years; subjects must be less than 18 at the time of signing assent / consent.
3)Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the Screening Visit.
Exclusion Criteria:
Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine
The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
The subject has a history or diagnosis of complications of migraine
The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.
The subject has any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Subjects with a lifetime history of psychosis and/or mania are excluded.
History of suicidal behavior or the subject is at risk of self-harm or harm to others.
History of major psychiatric disorder.
The subject has a current diagnosis or history of substance abuse
The subject has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator's opinion, likely to affect central nervous system functioning.
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
The Belinga Clinic
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72901
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Investigative Medicine, Inc.
City
Hawthorne
State/Province
California
ZIP/Postal Code
90250
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research San Diego
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research of California
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
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
Not yet recruiting
Facility Name
Advanced Neurosciences Research, LLC
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research, LLC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Individual Site Status
Recruiting
Facility Name
Synergy Healthcare
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Individual Site Status
Recruiting
Facility Name
Vertex Research Group
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
Country
United States
Individual Site Status
Recruiting
Facility Name
Complete Health Research
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Individual Site Status
Recruiting
Facility Name
Direct Helpers Research Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Recruiting
Facility Name
New Med Research, Inc
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33020
Country
United States
Individual Site Status
Recruiting
Facility Name
Axcess Medical Research
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Individual Site Status
Recruiting
Facility Name
Sanitas Research, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
APG Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Name
Complete Health Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Individual Site Status
Recruiting
Facility Name
D&H Tamarac Research Center LLC
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Individual Site Status
Recruiting
Facility Name
Santos Research Center, CORP
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Individual Site Status
Recruiting
Facility Name
WR-Mount Vernon Clinical Research, LLC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research, LLC
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Individual Site Status
Recruiting
Facility Name
Extraordinary Family Healthcare
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Individual Site Status
Recruiting
Facility Name
Renew Health Clinical Research LLC
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Clinical Trials, Inc.
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Individual Site Status
Recruiting
Facility Name
Diamond Headache Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60642
Country
United States
Individual Site Status
Terminated
Facility Name
Safe Haven Clinical Research
City
Clinton
State/Province
Mississippi
ZIP/Postal Code
39056
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Missouri Health Care - Clinical Research Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Missouri Health Care - Investigation Pharmacy (IP to be shipped here)
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Missouri Health Care - Pathology Department
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Missouri School of Medicine
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research, LLC
City
Hastings
State/Province
Nebraska
ZIP/Postal Code
68901
Country
United States
Individual Site Status
Recruiting
Facility Name
Midwest Children's Health Research Institute, LLC
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68504
Country
United States
Individual Site Status
Recruiting
Facility Name
Papillion Research Center/CCT Research
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Individual Site Status
Recruiting
Facility Name
Renown Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Individual Site Status
Recruiting
Facility Name
Ocean Medical Research
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Individual Site Status
Recruiting
Facility Name
Albuquerque Neuroscience Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Individual Site Status
Recruiting
Facility Name
Dent Neurosciences Research Center, Inc.
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Individual Site Status
Recruiting
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Name
Carolina Institute for Clinical Research, LLC
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28303
Country
United States
Individual Site Status
Recruiting
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research, LLC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Individual Site Status
Recruiting
Facility Name
Coastal Pediatric Research
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
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
Avera McKennan Hospital & University Health Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Recruiting
Facility Name
Avera Medical Group Pediatric Specialists
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Individual Site Status
Recruiting
Facility Name
Avera Research Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Individual Site Status
Recruiting
Facility Name
Monroe Carell Jr Children's Hospital at Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Name
DCT-Baxter Research, LLC dba Discovery Clinical Trials
City
Dallas
State/Province
Texas
ZIP/Postal Code
75225
Country
United States
Individual Site Status
Recruiting
Facility Name
DM Clinical Research - Cy Fair
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
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
Red Star Research, LLC
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Individual Site Status
Recruiting
Facility Name
DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Individual Site Status
Recruiting
Facility Name
DCT-Stone Oak, LLC dba Discovery Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Institute for Neurological Disorders
City
Sherman
State/Province
Texas
ZIP/Postal Code
75092
Country
United States
Individual Site Status
Recruiting
Facility Name
DM Clinical Research (Administrative Office Only)
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Individual Site Status
Recruiting
Facility Name
Victoria Clinical Research Group
City
Victoria
State/Province
Texas
ZIP/Postal Code
77901
Country
United States
Individual Site Status
Recruiting
Facility Name
South Ogden Family Medicine Ogden Clinic/CCT Research
City
South Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research, LLC
City
Portsmouth
State/Province
Virginia
ZIP/Postal Code
23703
Country
United States
Individual Site Status
Recruiting
Facility Name
The Kids Clinic
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1Z 0M1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
Centre Hospitalier Intercommunal de Créteil
City
Créteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hopital des Enfants
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Unita di Neurologia, Azienda Ospedaliera San Giuseppe Moscati
City
Avellino
State/Province
Avellino/campania
ZIP/Postal Code
83100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Spaienza Universita di Roma Polo Pontino - ICOT, Headache clinic
City
Latina
State/Province
Latina/lazio
ZIP/Postal Code
04100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
U.O. di Neurologia- ASST Spedali Civili di Brescia
City
Brescia
State/Province
Lombardy
ZIP/Postal Code
25069
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Fondazione Mondino - Istituto Neurologico Nazionale IRCCS
City
Pavia
State/Province
Padua
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
IRCCS San Raffaele Roma
City
Rome
ZIP/Postal Code
00197
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
52-210
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-582
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-123
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
61-734
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Wojewodzki Specjalistyczny Szpital Dzieciecy im. sw. Ludwika w Krakowie
City
Krakow
ZIP/Postal Code
31-503
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
NZOZ Neuromed M. i M. Nastaj Sp. P.
City
Lublin
ZIP/Postal Code
20-064
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
MTZ Clinical Research Sp. z o.o.
City
Warszawa
ZIP/Postal Code
02-106
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Parc Tauli
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valladolid (HCUV)
City
Valladolid
State/Province
Castilla Y LEON
ZIP/Postal Code
47003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Alvaro Cunqueiro
City
Vigo
State/Province
Galicia
ZIP/Postal Code
36312
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Santiago de Compostela
City
Santiago de Compostela
State/Province
LA Coruna
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Virgen del Rocio Hospital
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario y Politecnico La Fe
City
Valencia
ZIP/Postal Code
46026
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=BHV3000-315
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
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