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| ID | Type | Description | Link |
|---|---|---|---|
| BHV3000-320 | Other Identifier | Alias Study Number | |
| 2023-505601-16-00 | Registry Identifier | CTIS (EU) |
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The purpose of this study is to learn about the effect of a study medicine called rimegepant in adolescents who have frequent migraine attacks.
Rimegepant is a tablet that dissolves when you put it on or under your tongue.
The study will enroll participants who have headache for 15 days (or more) every month, of which 8 days (or more) of migraine every month, and each untreated attack lasts for an average of 4-72 hours
In the 1st part of the study approximately half of the participants will receive a rimegepant tablet every other day, and approximately half of the participants will receive an inactive oral tablet (that looks the same as the rimegepant tablet) every other day.
Participant experiences when they are taking the study medicine will be compared to when they are taking the inactive tablet. This will help to determine if the study medicine is safe and effective. The 1st phase of the study will last 3 months.
In the 2nd part of the study all the participants who stay on study will receive rimegepant tablet every other day. This 2nd phase of the study will last 1 year. This will help determine if the study medicine is safe when taken for a long period.
Those who will participate in both phases will have up to 19 visits at the study clinic, about one every 4 weeks (this may vary from 2 to 8 weeks interval during the study). Home health visits may occur as well. A health check and blood sample will be conducted at all visits. Participants will have to complete a daily diary to record the migraine attacks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rimegepant | Experimental | Experimental medicine under study |
|
| Placebo | Placebo Comparator | A placebo does not have any medicine in it but looks just like the medicine being studied. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimegepant | Drug | Rimegepant 75 mg orally disintegrating tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of migraine days per month | Efficacy of rimegepant relative to placebo, measured as mean change from the baseline in the number of migraine days per month | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the number of acute migraine-specific medication days per month | Change in the use of acute migraine-specific medication days per month | 12 Weeks |
| Efficacy of rimegepant relative to placebo measured the mean change from baseline in the number of headache days per month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Xenoscience Inc | Recruiting | Phoenix | Arizona | 85004 | United States | |
| Adult & Child Neurology Medical Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41235617 | Derived | Shin L, Mentz O, Gelfand AA, de Prado BM, Shapiro H, Oh A, Onifade OO, Saunders J, Raj N, Szperka CL. Gepants for headache prevention in children and adolescents: A multicenter chart review study. Headache. 2026 Jan;66(1):239-248. doi: 10.1111/head.15087. Epub 2025 Nov 14. |
| 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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| Placebo |
| Drug |
Matching placebo oral disintegrating tablets |
|
Change in headache days per month |
| 12 Weeks |
| Efficacy of rimegepant relative to placebo measured as the percentage of participants with at least 50% reduction from baseline in number of moderate or severe migraine days per month | Change in moderate or severe migraine days per month | 12 weeks |
| Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the Pediatric Quality of Life (PedsQL™) total score | Change in the Quality of Life | 12 Weeks |
| Efficacy of rimegepant relative to placebo measure as the mean change from baseline in the number of acute headache medication days per month, and acute migraine-specific medication days per month | Change in headache and migraine rescue medication(s) used | 12 Weeks |
| Safety of rimegepant relative to placebo, and safety of rimegepant given for a long period of time measured as the number and percentage of participants with adverse event by severity and overall | Safety and tolerability of the study drug | Up to 15 months |
| Safety of rimegepant relative to placebo, and safety of rimegepant given for long period of time measured as the number and percentage of participants with liver-related adverse event and action taken | Safety monitoring of adverse events of special interest | Up to 15 Months |
| Efficacy of rimegepant relative to placebo measured as mean change from baseline in the PedMIDAS total score | Change in the Quality of Life | 12 Weeks |
| Recruiting |
| Long Beach |
| California |
| 90806 |
| United States |
| Children's Hospital Colorado | Recruiting | Aurora | Colorado | 80045 | United States |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Recruiting | Chicago | Illinois | 60611 | United States |
| Chicago Headache Center and Research Institute | Recruiting | Chicago | Illinois | 60657 | United States |
| Chicago Headache Center and Research Institute | Recruiting | Naperville | Illinois | 60563 | United States |
| New England Regional Headache Center | Recruiting | Worcester | Massachusetts | 01609 | United States |
| Michigan Headache & Neurological Institute | Recruiting | Ann Arbor | Michigan | 48104 | United States |
| Clinvest Headlands Llc | Recruiting | Springfield | Missouri | 65807 | United States |
| Rutgers University | Recruiting | New Brunswick | New Jersey | 08901 | United States |
| OnSite Clinical Solutions | Recruiting | Charlotte | North Carolina | 28211 | United States |
| Duke Health Center Creekstone | Recruiting | Durham | North Carolina | 27703 | United States |
| Duke Lenox Baker Children's | Recruiting | Durham | North Carolina | 27705 | United States |
| Duke Children's Health Center | Recruiting | Durham | North Carolina | 27710 | United States |
| Wake Forest University Baptist Medical Center ( WFUBMC ) | Active, not recruiting | Winston-Salem | North Carolina | 27157 | United States |
| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
| UPMC Children's Hospital of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15224 | United States |
| Avera Medical Group Pediatric Specialists | Recruiting | Sioux Falls | South Dakota | 57105 | United States |
| Avera Research Institute - Sioux Falls | Recruiting | Sioux Falls | South Dakota | 57108 | United States |
| Avera Medical Group Pediatrics - Dawley Farm | Recruiting | Sioux Falls | South Dakota | 57110 | United States |
| Dell Children's Medical Center | Recruiting | Austin | Texas | 78723 | United States |
| Headlands Research-El Paso | Recruiting | El Paso | Texas | 79902 | United States |
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
| Wasatch Clinical Research, LLC | Recruiting | Salt Lake City | Utah | 84107 | United States |
| Granger Medical Holladay - Holladay Clinic | Recruiting | Salt Lake City | Utah | 84117 | United States |
| Seattle Children's Hospital | Recruiting | Seattle | Washington | 98105 | United States |
| University Of Alberta Hospital | Recruiting | Edmonton | Alberta | T6G 1W9 | Canada |
| Stollery Children's Hospital | Recruiting | Edmonton | Alberta | T6G 2B7 | Canada |
| CaRe Clinic | Recruiting | Red Deer | Alberta | T4P 1K4 | Canada |
| London Health Sciences Centre - Verspeeten Family Cancer Centre | Recruiting | London | Ontario | N6A 5W9 | Canada |
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400016 | China |
| Guangzhou First People's Hospital | Recruiting | Guangzhou | Guangdong | 510180 | China |
| Jingzhou First People's Hospital | Recruiting | Jingzhou | Hubei | 434000 | China |
| Wuhan Children's Hospital | Recruiting | Wuhan | Hubei | 430010 | China |
| The Second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410011 | China |
| The Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410013 | China |
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
| Wuxi Children's Hospital | Recruiting | Wuxi | Jiangsu | 214023 | China |
| Affiliated Hospital of Jiangsu University | Recruiting | Zhenjiang | Jiangsu | 212001 | China |
| General Hospital of Ningxia Medical University | Recruiting | Yinchuan | Ningxia | 750004 | China |
| Anhui Provincial Hospital | Recruiting | Hefei | 230001 | China |
| Shanghai Children's Hospital | Recruiting | Shanghai | 200062 | China |
| The Second Affiliated Hospital of Hebei Medical University | Recruiting | Shijiazhuang | China |
| Detska nemocnice FN Brno | Recruiting | Brno | Brno-město | 613 00 | Czechia |
| Fakultni nemocnice Hradec Kralove | Recruiting | Hradec Králové | Hradec Králové | 500 05 | Czechia |
| Fakultni nemocnice Ostrava | Recruiting | Ostrava | Moravian-Silesian Region | 708 52 | Czechia |
| Fakultni Thomayerova nemocnice | Recruiting | Prague | Praha 4 | 14059 | Czechia |
| Fakultni Nemocnice Motol a Homolka | Recruiting | Prague | 150 06 | Czechia |
| Terveystalo Oulu | Recruiting | Oulu | North Ostrobothnia | 90100 | Finland |
| Kuopion Yliopistollinen Sairaala | Recruiting | Kuopio | Northern Savonia | 70210 | Finland |
| Tampereen yliopistollinen sairaala | Recruiting | Tampere | Pirkanmaa | 33520 | Finland |
| Turku University Hospital | Recruiting | Turku | Southwest Finland | 20520 | Finland |
| Clinical Research Institute Helsinki University Central Hospital Ltd | Recruiting | Helsinki | 00280 | Finland |
| New Children's Hospital | Recruiting | Helsinki | 00290 | Finland |
| Terveystalo Tampere | Recruiting | Tampere | 33100 | Finland |
| Terveystalo Pulssi | Recruiting | Turku | 20100 | Finland |
| Dr. Kenessey Albert Kórház | Recruiting | Balassagyarmat | Nógrád megye | 2660 | Hungary |
| Nagykanizsai Kanizsai Dorottya Korhaz | Recruiting | Nagykanizsa | Zala County | 8800 | Hungary |
| Semmelweis Egyetem | Recruiting | Budapest | 1083 | Hungary |
| Artemis hospital | Recruiting | Gurugram | Haryana | 122001 | India |
| Fortis Memorial Research Institute | Recruiting | Gurugram | Haryana | 122002 | India |
| Mallikatta Neuro Centre | Recruiting | Mangalore | Karnataka | 575002 | India |
| Chopda Medicare & Research Centre Pvt. Ltd; Magnum Heart Institute | Recruiting | Nashik | Maharashtra | 422005 | India |
| All India Institute of Medical Sciences | Recruiting | New Delhi | National Capital Territory of Delhi | 110029 | India |
| Sir Ganga Ram Hospital | Recruiting | New Delhi | National Capital Territory of Delhi | 110060 | India |
| ASL1 Avezzano-Sulmona-L'Aquila | Recruiting | L’Aquila | Abruzzo | 67100 | Italy |
| Ospedale San Paolo Bari | Recruiting | Bari | Apulia | 70132 | Italy |
| IRCCS Istituto Neurologico Carlo Besta | Recruiting | Milan | Lombardy | 20133 | Italy |
| IRCCS San Raffaele Roma | Active, not recruiting | Rome | ROMA | 00163 | Italy |
| Asst Spedali Civili Di Brescia | Recruiting | Brescia | 25123 | Italy |
| I.C.O.T. Università La Sapienza | Recruiting | Latina | 04100 | Italy |
| Fondazione Istituto Neurologico C. Mondino | Recruiting | Pavia | 27100 | Italy |
| IRCCS San Raffaele Roma | Active, not recruiting | Roma | 00166 | Italy |
| Konan Medical Center | Recruiting | Kobe | Hyōgo | 658-0064 | Japan |
| Yamaguchi Clinic | Recruiting | Nishinomiya | Hyōgo | 663-8204 | Japan |
| Tominaga Clinic | Recruiting | Osaka | Osaka | 556-0015 | Japan |
| Tokyo Headache Clinic | Recruiting | Shibuya-ku | Tokyo | 151-0051 | Japan |
| Nagaseki Headache Clinic | Recruiting | Kai | Yamanashi | 400-0124 | Japan |
| Tanaka Neurosurgery&Headache Clinic | Recruiting | Kagoshima | 890-0052 | Japan |
| Tennoji Department of Neurosurgery | Recruiting | Osaka | 545-0053 | Japan |
| AthleticoMed | Recruiting | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-752 | Poland |
| Specjalistyczne Gabinety Sp. z o.o. | Recruiting | Krakow | Lesser Poland Voivodeship | 30-539 | Poland |
| MIGRE Polskie Centrum Leczenia Migreny | Recruiting | Wroclaw | Lower Silesian Voivodeship | 52-210 | Poland |
| MedicArt Sp. z o. o. | Recruiting | Wroclaw | Lower Silesian Voivodeship | 53-025 | Poland |
| Centrum Medyczne Hope Clinic Sebastian Szklener | Recruiting | Lublin | Lublin Voivodeship | 20-701 | Poland |
| Dr Sękowska Leczenie Bólu | Recruiting | Warsaw | Masovian Voivodeship | 01-018 | Poland |
| Neurosphera | Recruiting | Warsaw | Masovian Voivodeship | 02-829 | Poland |
| Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś | Recruiting | Warsaw | Masovian Voivodeship | 04-501 | Poland |
| NZOZ Neuromed M. i M. Nastaj Sp. P. | Recruiting | Lublin | 20-064 | Poland |
| Detska fakultna nemocnica s poliklinikou Banska Bystrica | Recruiting | Banská Bystrica | 97409 | Slovakia |
| IN MEDIC s.r.o. | Recruiting | Bardejov | Slovakia |
| KONZILIUM s.r.o. | Recruiting | Dubnica nad Váhom | Slovakia |
| Univerzitna nemocnica Martin | Recruiting | Martin | 036 59 | Slovakia |
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | Barcelona [barcelona] | 08035 | Spain |
| Hospital Universitario HM Puerta del Sur | Recruiting | Madrid | Madrid, Comunidad de | 28938 | Spain |
| CHUVI- Hospital Alvaro Cunqueiro | Recruiting | Vigo | Pontevedra | 36213 | Spain |
| Hospital Universitario HM Sanchinarro | Recruiting | Madrid | 28050 | Spain |
| Hospital Universitario Virgen Del Rocio | Recruiting | Seville | 41013 | Spain |
| Hospital Universitari i Politecnic La Fe | Recruiting | Valencia | 46026 | Spain |
| Hospital Clínico Universitario de Valladolid | Recruiting | Valladolid | 47005 | Spain |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C578443 | rimegepant sulfate |
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