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| ID | Type | Description | Link |
|---|---|---|---|
| C4951003 | Other Identifier | Alias Study Number | |
| 2024-512744-32-00 | Registry Identifier | CTIS (EU) |
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The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to < 18 years of age).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | rimegepant 75 mg, 50 mg or 35 mg ODT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimegepant (PF-07899801) | Drug | Rimegepant 75 mg, 50 mg or 35 mg ODT |
|
| Measure | Description | Time Frame |
|---|---|---|
| The frequency and severity of on-treatment and treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, clinically significant lab abnormalities | To evaluate the safety and tolerability of rimegepant in children and adolescents (6 to < 18 years of age). | 58 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The frequency and severity of hepatic-related adverse events and frequency of hepatic-related adverse events leading to treatment discontinuation | To evaluate the frequency and severity of hepatic-related adverse events and the frequency of hepatic-related treatment discontinuations in children and adolescents (6 to less than 18 years of age) treated with rimegepant. | 58 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Perseverance Research Center, LLC | Recruiting | Scottsdale | Arizona | 85253 | United States | |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| Physicians Research Group |
| Active, not recruiting |
| Tempe |
| Arizona |
| 85284 |
| United States |
| Advanced Research Center, Inc. | Recruiting | Anaheim | California | 92805 | United States |
| ProScience Research Group | Active, not recruiting | Culver City | California | 90230 | United States |
| Neuro-Pain Research Center | Recruiting | Fresno | California | 93710 | United States |
| Altman Clinical and Translational Research Institute, University of California San Diego | Recruiting | La Jolla | California | 93037 | United States |
| Adult & Child Neurology Medical Associates | Recruiting | Long Beach | California | 90806 | United States |
| Memorialcare Miller Children's & Women's Hospital Long Beach | Recruiting | Long Beach | California | 90806 | United States |
| Velocity Clinical Research - North Hollywood | Active, not recruiting | North Hollywood | California | 91606 | United States |
| The Neurology Group | Recruiting | Pomona | California | 91767 | United States |
| UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy | Active, not recruiting | Sacramento | California | 95817 | United States |
| University of California, Davis Clinical and Translational Science Center Clinical Research Center | Active, not recruiting | Sacramento | California | 95817 | United States |
| University of California, Davis Midtown Clinic | Active, not recruiting | Sacramento | California | 95817 | United States |
| Velocity Clinical Research- Banning | Recruiting | San Bernardino | California | 92408 | United States |
| Pacific Clinical Research Management Group LLC | Active, not recruiting | Upland | California | 91786 | United States |
| Sunwise Clinical Research | Recruiting | Walnut Creek | California | 94596 | United States |
| Children's Hospital Colorado- Investigational Drug Services | Recruiting | Aurora | Colorado | 80045 | United States |
| Children's Hospital Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
| Colorado Springs Neurological Associates, PC | Active, not recruiting | Colorado Springs | Colorado | 80907 | United States |
| Colorado Springs Neurological Associates, PC | Active, not recruiting | Colorado Springs | Colorado | 80919 | United States |
| Boeson Research GJT | Terminated | Grand Junction | Colorado | 81501 | United States |
| Dinosaur Pediatrics | Terminated | Grand Junction | Colorado | 81501 | United States |
| Boeson Research GJT | Terminated | Grand Junction | Colorado | 81505 | United States |
| CT Clinical Research | Recruiting | Cromwell | Connecticut | 06416 | United States |
| Ki Health Partners, LLc, dba New England Institute for Clinical Research | Recruiting | Stamford | Connecticut | 06905 | United States |
| Children's National Medical Center | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
| AppleMed Research Group, LLC | Active, not recruiting | Miami | Florida | 33126 | United States |
| Medical Research Center of Miami II, Inc | Active, not recruiting | Miami | Florida | 33134 | United States |
| South Florida Research Phase I-IV, Inc | Recruiting | Miami | Florida | 33166 | United States |
| Physicians Group Services, PA d/b/a Coastal Health Research | Active, not recruiting | Orange Park | Florida | 32073 | United States |
| Clinical Associates of Orlando, LLC | Recruiting | Orlando | Florida | 32819 | United States |
| ForCare Clinical Research | Active, not recruiting | Tampa | Florida | 33613 | United States |
| Premiere Research Institute at Palm Beach Neurology | Active, not recruiting | West Palm Beach | Florida | 33407 | United States |
| Childrens Healthcare of Atlanta | Recruiting | Atlanta | Georgia | 30329 | United States |
| Rare Disease Research LLC | Active, not recruiting | Atlanta | Georgia | 30329 | United States |
| Pivotal Clinical Research & Associates, LLC | Recruiting | Brunswick | Georgia | 31520 | United States |
| CenExel iResearch, LLC | Recruiting | Decatur | Georgia | 30030 | United States |
| Chicago Headache Center & Research Institute | Recruiting | Chicago | Illinois | 60657 | United States |
| AMR-Baber Research Inc | Recruiting | Naperville | Illinois | 60563 | United States |
| Options Research Group, LLC | Recruiting | Westfield | Indiana | 46074 | United States |
| Integrated Clinical Trial Services, Inc. | Recruiting | West Des Moines | Iowa | 50265 | United States |
| Clinical Associates Midwest, LLC | Recruiting | Kansas City | Kansas | 66214 | United States |
| University of Kentucky Hospital | Active, not recruiting | Lexington | Kentucky | 40536 | United States |
| Ochsner Clinic Foundation | Terminated | New Orleans | Louisiana | 70121 | United States |
| MedVadis Research Corporation | Active, not recruiting | Waltham | Massachusetts | 02451 | United States |
| Michigan Head Pain and Neurological Institute | Recruiting | Ann Arbor | Michigan | 48104 | United States |
| Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group | Recruiting | Grand Rapids | Michigan | 49503 | United States |
| Corewell Health, Helen DeVos Children's Hospital | Recruiting | Grand Rapids | Michigan | 49503 | United States |
| Wellnow Urgent Care and Research | Terminated | Kalamazoo | Michigan | 49048 | United States |
| Beaumont Hospital, Royal Oak Campus | Recruiting | Royal Oak | Michigan | 48073 | United States |
| Sharlin Health Neuroscience Research Center | Active, not recruiting | Ozark | Missouri | 65721 | United States |
| Clinvest Research, LLC | Active, not recruiting | Springfield | Missouri | 65807 | United States |
| Boeson Research | Recruiting | Great Falls | Montana | 59405 | United States |
| Heart & Hands Midwifery | Active, not recruiting | Kalispell | Montana | 59901 | United States |
| Blue Moose Pediatrics | Recruiting | Missoula | Montana | 59804 | United States |
| Boeson Research Laboratory | Recruiting | Missoula | Montana | 59804 | United States |
| Boeson Research | Recruiting | Missoula | Montana | 59804 | United States |
| Alivation Research, LLC | Terminated | Lincoln | Nebraska | 68526 | United States |
| Children's Hospital & Medical Center | Recruiting | Omaha | Nebraska | 68114 | United States |
| HMH Jersey Shore University Medical Center | Recruiting | Neptune City | New Jersey | 07753 | United States |
| Hope Tower | Recruiting | Neptune City | New Jersey | 07753 | United States |
| Dent Neurosciences Research Center | Recruiting | Amherst | New York | 14226 | United States |
| True North Neurology | Recruiting | Commack | New York | 11725 | United States |
| New York Neurology Associates | Recruiting | New York | New York | 10003 | United States |
| Mount Sinai Hospital - Pharmacy Department | Active, not recruiting | New York | New York | 10029 | United States |
| Columbia University Irving Medical Center | Active, not recruiting | New York | New York | 10032 | United States |
| Irving Center for Clinical and Translational Research, Outpatient Clinical Research Unit | Active, not recruiting | New York | New York | 10032 | United States |
| The Neurological Institute of New York | Active, not recruiting | New York | New York | 10032 | United States |
| North Suffolk Neurology | Active, not recruiting | Port Jefferson Station | New York | 11776 | United States |
| OnSite Clinical Solutions, LLC | Recruiting | Charlotte | North Carolina | 28277 | United States |
| Headache Wellness Center, PC | Active, not recruiting | Greensboro | North Carolina | 27405 | United States |
| WellNow Urgent Care and Research | Active, not recruiting | Cincinnati | Ohio | 45215 | United States |
| Cincinnati Children's Hospital | Recruiting | Cincinnati | Ohio | 45229 | United States |
| Velocity Clinical Research - Cincinnati | Recruiting | Cincinnati | Ohio | 45242 | United States |
| University Hospitals Cleveland Medical Center | Recruiting | Cleveland | Ohio | 44106 | United States |
| Wellnow Urgent Care and Research | Active, not recruiting | Dayton | Ohio | 45424 | United States |
| IPS Research Company | Active, not recruiting | Oklahoma City | Oklahoma | 73106 | United States |
| Velocity Clinical Research, Grants Pass | Active, not recruiting | Grants Pass | Oregon | 97527 | United States |
| Providence Neuroscience Institute: Research Coordinators' Office | Recruiting | Portland | Oregon | 97225 | United States |
| Providence Pediatric Specialty Clinic | Recruiting | Portland | Oregon | 97225 | United States |
| Clario | Active, not recruiting | Philadelphia | Pennsylvania | 19103 | United States |
| Children's Hospital of Philadelphia | Active, not recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Velocity Clinical Research-Providence | Recruiting | East Greenwich | Rhode Island | 02818 | United States |
| Velocity Clinical Research- Greenville | Active, not recruiting | Greenville | South Carolina | 29615 | United States |
| Premier Neurology | Active, not recruiting | Greer | South Carolina | 29650 | United States |
| Novaceut Clinical Research | Active, not recruiting | Clarksville | Tennessee | 37043 | United States |
| Le Bonheur Children's Hospital | Active, not recruiting | Memphis | Tennessee | 37103 | United States |
| Le Bonheur Childrens Hospital - Childrens Foundation Research Institute | Active, not recruiting | Memphis | Tennessee | 38103 | United States |
| Le Bonheur Childrens Hospital - Outpatient Building | Active, not recruiting | Memphis | Tennessee | 38103 | United States |
| Access Clinical Trials, Inc. | Terminated | Nashville | Tennessee | 37203 | United States |
| Dell Children's Medical Center | Recruiting | Austin | Texas | 78723 | United States |
| Child Neurology Consultants of Austin - South Austin | Active, not recruiting | Austin | Texas | 78749 | United States |
| Child Neurology Consultants of Austin - Central Austin | Recruiting | Austin | Texas | 78757 | United States |
| Houston Clinical Trials, LLC | Recruiting | Bellaire | Texas | 77401 | United States |
| Infinite Research Group, LLC | Active, not recruiting | Dallas | Texas | 75201 | United States |
| Cedar Health Research | Active, not recruiting | Dallas | Texas | 75251 | United States |
| ANESC Research | Recruiting | El Paso | Texas | 79912 | United States |
| North Texas Institute of Neurology and Headache | Active, not recruiting | Frisco | Texas | 75034 | United States |
| Trio Clinical Trials, LLC. | Active, not recruiting | Houston | Texas | 77008 | United States |
| Pain and Headache Centers of Texas | Recruiting | Houston | Texas | 77054 | United States |
| SCLA Management | Recruiting | Houston | Texas | 77077 | United States |
| Houston Clinical Research,LLC. | Terminated | Houston | Texas | 77081 | United States |
| NeuroCare Plus | Recruiting | Houston | Texas | 77094 | United States |
| AIM Trials, LLC | Recruiting | Plano | Texas | 75093 | United States |
| JBR Clinical Research | Recruiting | Salt Lake City | Utah | 84107 | United States |
| Wasatch Clinical Research , LLC(Administrative Location) | Recruiting | Salt Lake City | Utah | 84107 | United States |
| Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice) | Recruiting | Charlottesville | Virginia | 22902 | United States |
| Pediatric Research of Charlottesville, LLC (Regulatory Only) | Recruiting | Charlottesville | Virginia | 22902 | United States |
| Pediatric Research of Charlottesville, LLC | Recruiting | Charlottesville | Virginia | 22902 | United States |
| Children's Hospital of The King's Daughters | Recruiting | Norfolk | Virginia | 23507 | United States |
| Children's Specialty Group, PLLC , Division of Childhood & Adolescent Neurology | Recruiting | Norfolk | Virginia | 23510 | United States |
| National Clinical Research, Inc. | Terminated | Richmond | Virginia | 23294 | United States |
| Northwest Clinical Research Center | Recruiting | Bellevue | Washington | 98007 | United States |
| Seattle Children's Hospital Investigational Drug Services | Recruiting | Seattle | Washington | 98105 | United States |
| Seattle Children's Hospital | Recruiting | Seattle | Washington | 98105 | United States |
| University Hospital | Recruiting | Madison | Wisconsin | 53792 | United States |
| NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski | Terminated | Katowice | 40-123 | Poland |
| Centrum Medyczne Plejady | Recruiting | Krakow | 30-363 | Poland |
| Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Oddzial Kliniczny Dzieci | Recruiting | Krakow | 31-503 | Poland |
| Clinical Research Center Sp. z o.o. | Recruiting | Poznan | 60-848 | Poland |
| Pracownia Badan Klinicznych SALUS | Recruiting | Wroclaw | 52-210 | Poland |
| Centrum Medyczne Oporow | Active, not recruiting | Wroclaw | 52-416 | Poland |
| Centre Atencio Primaria (CAP) Balenya | Active, not recruiting | Balenya | Barcelona | 08550 | Spain |
| Hospital Universitario Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital Clinico Universitario de Valladolid | Recruiting | Valladolid | 47003 | Spain |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D012001 | Hyperacusis |
| D020795 | Photophobia |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014786 | Vision Disorders |
| D005128 | Eye Diseases |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| C578443 | rimegepant sulfate |
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