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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06641466 | Registry Identifier | ClinicalTrials.gov |
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The purpose of this study is to evaluate the efficacy and safety of rimegepant when administered during the peri-menstrual period (PMP) for intermittent prevention of migraine in women who experience menstrual migraine attacks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rimegepant 75 mg Orally Disintegrating Tablet (ODT) 7-Day Dosing | Experimental |
| |
| Rimegepant 75 mg Orally Disintegrating Tablet (ODT) Acute Treatment Dosing | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Standard of Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimegepant | Drug | Rimegepant 75 mg ODT for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase | Change from Observation Period in the number of migraine days per the 5-day perimenstrual period | 5 months (5 menstrual cycles) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from the Observation Period in number of headache days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase | Change from the Observation Period in number of headache days per 5-day perimenstrual period | 5 months (5 menstrual cycles) |
| Percentage of participants with ≥50% reduction from the Observation Period in number of migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase (50% responder) |
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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 |
|---|---|---|---|---|---|---|
| Mayo Clinic Hospital | Recruiting | Phoenix | Arizona | 85054 | United States | |
| Mayo Clinic Specialty Building |
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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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| Placebo Comparator | Drug | Matching placebo oral disintegrating tablets for 7 days |
|
| Standard of Care | Drug | Standard of care for acute treatment as needed |
|
| Rimegepant | Drug | Rimegepant 75 mg ODT for acute treatment as needed |
|
Patients with ≥50% reduction from the Observation Period in number of migraine days per 5-day perimenstrual period |
| 5 months (5 menstrual cycles) |
| Mean change from the Observation Period in number of acute migraine medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase | Change from the Observation Period in number of acute migraine medication days per 5-day perimenstrual period | 5 months (5 menstrual cycles) |
| Mean change from the Observation Period in number of acute migraine-specific medication days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase | Change from the Observation Period in number of acute migraine specific medication days per 5-day perimenstrual period | 5 months (5 menstrual cycles) |
| Mean change from the Observation Period in number of migraine days with moderate-severe functional disability per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase | Change from the Observation Period in number of migraine days with moderate-severe functional disability per 5-day perimenstrual period | 5 months (5 menstrual cycles) |
| Mean change from the Observation Period in number of moderate-severe headache days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase | Change from the Observation Period in number of moderate-severe headache days per 5-day perimenstrual period | 5 months (5 menstrual cycles) |
| Mean change from the Observation Period in number of moderate-severe migraine days per 5-day perimenstrual period across each cycle of the Double-Blind Treatment Phase | Change from the Observation Phase in number of moderate-severe migraine days per 5-day perimenstrual period | 5 months (5 menstrual cycles) |
| Mean change from baseline in the MiCOAS Cognition score at postdosing (ie, 1 day after the 7-day dosing period) across each cycle of the Double-Blind Treatment Phase | Change from baseline in the MiCOAS Cognition score at post-dosing across each cycle | 5 months (5 menstrual cycles) |
| Mean change from the Observation Period in monthly migraine days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase | Change from the Observation Phase in monthly migraine days | 5 months (5 menstrual cycles) |
| Mean change from the Observation Period in monthly headache days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase | Change from the Observation Phase in monthly headache days | 5 months (5 menstrual cycles) |
| Mean change from the Observation Phase in monthly acute migraine-specific medication days (per cycle, normalized to 28-days) across each cycle of the Double-Blind Treatment Phase | Change from the Observation Phase in monthly acute migraine-specific medication days | 5 months (5 menstrual cycles) |
| Recruiting |
| Phoenix |
| Arizona |
| 85054 |
| United States |
| Mayo Clinic Arizona | Recruiting | Scottsdale | Arizona | 85259 | United States |
| Hope Clinical Research, Inc. | Recruiting | Canoga Park | California | 91303 | United States |
| Axiom Research | Recruiting | Colton | California | 92324 | United States |
| Diablo Clinical Research, Inc. | Recruiting | Walnut Creek | California | 94598 | United States |
| VIN - Aventura | Recruiting | Aventura | Florida | 33180 | United States |
| Velocity Clinical Research, Hallandale Beach | Recruiting | Hallandale | Florida | 33009 | United States |
| Jacksonville Center for Clinical Research | Recruiting | Jacksonville | Florida | 32216 | United States |
| Urban Family Practice Associates | Recruiting | Marietta | Georgia | 30067 | United States |
| Clinical Research Atlanta | Recruiting | Stockbridge | Georgia | 30281 | United States |
| St Luke's Clinic - Neurology | Recruiting | Meridian | Idaho | 83642 | United States |
| Alliance for Multispecialty Research - Medisphere Medical Research Center | Recruiting | Evansville | Indiana | 47714 | United States |
| Michigan Headache & Neurological Institute | Recruiting | Ann Arbor | Michigan | 48104 | United States |
| Clinvest Headlands Llc | Recruiting | Springfield | Missouri | 65807 | United States |
| St. Charles Clinical Research | Recruiting | Weldon Spring | Missouri | 63304 | United States |
| McGill Family Practice | Recruiting | Papillion | Nebraska | 68046 | United States |
| Excel Clinical Research, LLC | Recruiting | Las Vegas | Nevada | 89109 | United States |
| Rochester Clinical Research | Recruiting | Rochester | New York | 14609 | United States |
| Montefiore Medical Center | Recruiting | The Bronx | New York | 10461 | United States |
| Carolina Women's Research and Wellness Center | Recruiting | Durham | North Carolina | 27713 | United States |
| Dayton Center for Neurological Disorders | Recruiting | Centerville | Ohio | 45459 | United States |
| Thomas Jefferson University, Jefferson Headache Center | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Clinical Research of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19114 | United States |
| Velocity Clinical Research, Providence | Recruiting | East Greenwich | Rhode Island | 02818 | United States |
| Alliance for Multispecialty Research, LLC | Recruiting | Knoxville | Tennessee | 37909 | United States |
| AMR Clinical | Recruiting | Knoxville | Tennessee | 37909 | United States |
| Alliance for Multispecialty Research, LLC | Recruiting | Knoxville | Tennessee | 37920 | United States |
| FutureSearch Trials of Neurology | Recruiting | Austin | Texas | 78731 | United States |
| FutureSearch Trials of Dallas | Recruiting | Dallas | Texas | 75251 | United States |
| Charlottesville Medical Research | Recruiting | Charlottesville | Virginia | 22911 | United States |
| MedStar Health Neurology/MedStar Georgetown Headache Center | Recruiting | McLean | Virginia | 22101 | United States |
| Fundación para la lucha contra las enfermedades neurológicas de la infancia | Recruiting | CABA | Buenos Aires | 1428 | Argentina |
| IDIM - Instituto de Investigaciones Metabólicas | Recruiting | Buenos Aires | Buenos Aires F.D. | C1012AAR | Argentina |
| Mautalen Salud e Investigación | Recruiting | Buenos Aires | Buenos Aires F.D. | C1128AAF | Argentina |
| Hospital Cordoba | Recruiting | Cordoba Capital | Córdoba Province | 5004 | Argentina |
| Sanatorio del Sur | Recruiting | San Miguel de Tucumán | Tucumán Province | 4000 | Argentina |
| Clínica Privada Gallia | Recruiting | Córdoba | 5021 | Argentina |
| CaRe Clinic | Recruiting | Red Deer | Alberta | T4P 1K4 | Canada |
| OCT Research ULC | Recruiting | Kelowna | British Columbia | V1Y 1Z9 | Canada |
| Centre for Neurology Studies | Recruiting | Surrey | British Columbia | V3V 0E8 | Canada |
| Centricity Research Halifax Multispecialty | Recruiting | Halifax | Nova Scotia | B3S 1N2 | Canada |
| Aggarwal and Associates Limited | Recruiting | Brampton | Ontario | L6T 0G1 | Canada |
| Bluewater Clinical Research Group Inc. | Recruiting | Sarnia | Ontario | N7T 4X3 | Canada |
| Centre de Recherche Saint-Louis inc. | Recruiting | Lévis | Quebec | G6W 0Y3 | 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 |
| Hebei General Hospital | Recruiting | Shijiazhuang | Hebei | 050051 | China |
| The Second Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210011 | China |
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
| Shaanxi provincial people's hospital | Recruiting | Xi'an | Shaanxi | 710068 | China |
| Xianyang Hospital of Yan'an University | Recruiting | Xianyang | Shaanxi | 712000 | China |
| Huashan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
| Qingdao Central Hospital, University of Health and Rehabilitation Sciences | Recruiting | Qingdao | 266042 | China |
| Shanghai East Hospital | Recruiting | Shanghai | 200123 | China |
| Rigshospitalet, Glostrup | Recruiting | Glostrup Municipality | 2600 | Denmark |
| Region Midtjylland, Regionshospitalet Viborg | Recruiting | Viborg | 8800 | Denmark |
| Klinische Forschung Schwerin GmbH | Recruiting | Schwerin | Mecklenburg-Vorpommern | 19055 | Germany |
| Charité Universitaetsmedizin Berlin - Campus Mitte | Recruiting | Berlin | 10117 | Germany |
| FutureMeds GmbH | Recruiting | Berlin | 10629 | Germany |
| Neurologie Berlin | Recruiting | Berlin | 12163 | Germany |
| Lalitha PVS Institute of Medical Sciences | Recruiting | Guntur | Andhra Pradesh | 522001 | India |
| Marengo CIMS Hospital, Ahmedabad | Recruiting | Ahmedabad | Gujarat | 380060 | India |
| Mallikatta Neuro Centre | Recruiting | Mangaluru | Karnataka | 575002 | India |
| Topiwala National Medical College & B. Y. L. Nair Charitable Hospital | Recruiting | Mumbai | Maharashtra | 400008 | India |
| Getwell Hospital and Research Institute | Recruiting | Nagpur | Maharashtra | 440012 | India |
| Chopda Medicare & Research Centre Pvt. Ltd: Magnum Heart Institute | Recruiting | Nashik | Maharashtra | 422005 | India |
| Jawahar Lal Nehru Medical College | Recruiting | Ajmer | Rajasthan | 305001 | India |
| Sanjay Gandhi Post Graduate Institute of Medical Sciences | Recruiting | Lucknow | Uttar Pradesh | 226014 | India |
| Ospedale Civile SS. Nicola e Filippo Avezzano Pronto Soccorso | Recruiting | Avezzano | L'aquila | 67051 | Italy |
| Fondazione Policlinico Universitario Campus Biomedico | Recruiting | Rome | Lazio | 00128 | Italy |
| Ospedale Bellaria- Azienda USL di Bologna | Recruiting | Bologna | 40139 | Italy |
| Azienda Ospedaliera Universitaria Careggi | Recruiting | Florence | 50134 | Italy |
| Ospedale San Raffaele | Recruiting | Milan | 20132 | Italy |
| Fondazione Istituto Neurologico C. Mondino | Recruiting | Pavia | 27100 | Italy |
| IRCCS San Raffaele Roma | Recruiting | Roma | 00166 | Italy |
| Konan Medical Center | Recruiting | Kobe | Hyōgo | 658-0064 | Japan |
| Tatsuoka Neurology Clinic | Recruiting | Kyoto-shi Shimogyo-ku | Kyoto | 600-8811 | Japan |
| Sendai Headache and Neurology Clinic | Recruiting | Sendai | Miyagi | 982-0014 | 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 |
| Tanaka Neurosurgical Clinic | Recruiting | Kagoshima | 892-0844 | Japan |
| Centro de Investigación Médico Biológica y Terapia Avanzada | Recruiting | Guadalajara | Jalisco | 44130 | Mexico |
| Clinstile, S.A. de C.V. | Recruiting | Mexico City | Mexico City | 06700 | Mexico |
| Medical Care and Research SA de CV | Recruiting | Mérida | Yucatán | 97070 | Mexico |
| San Peregrino Unidad de Investigación | Recruiting | Aguascalientes | 20230 | Mexico |
| Operadora Unidad de Investigación en Salud de Chihuahua | Recruiting | Chihuahua City | 31203 | Mexico |
| PCR Cuautitlán Izcalli | Recruiting | Cuautitlán Izcalli | 54750 | Mexico |
| Clinical Research Institute S.C. | Recruiting | Tlalnepantla | 54055 | Mexico |
| Canisius-Wilhelmina Ziekenhuis | Recruiting | Nijmegen | Gelderland | 6532 SZ | Netherlands |
| Isala Klinieken Stichting | Recruiting | Zwolle | Overijssel | 8025 AB | Netherlands |
| Leids Universitair Medisch Centrum (LUMC) | Recruiting | Leiden | South Holland | 2333 ZA | Netherlands |
| Specjalistyczne Gabinety Sp. z o. o. | Recruiting | Krakow | Lesser Poland Voivodeship | 30-539 | Poland |
| Instytut Zdrowia Dr Boczarska Jedynak | Recruiting | Oświęcim | Lesser Poland Voivodeship | 32-600 | Poland |
| MIGRE Polskie Centrum Leczenia Migreny | Recruiting | Wroclaw | Lower Silesian Voivodeship | 52-210 | Poland |
| NZOZ Neuromed M.i M. Nastaj | Recruiting | Lublin | Lublin Voivodeship | 20-064 | Poland |
| Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej | Recruiting | Lublin | Lublin Voivodeship | 20-582 | Poland |
| FutureMeds Warszawa Centrum | Recruiting | Warsaw | Masovian Voivodeship | 00-215 | Poland |
| Dr Sękowska Leczenie Bólu | Recruiting | Warsaw | Masovian Voivodeship | 01-018 | Poland |
| Silmedic | Recruiting | Katowice | Silesian Voivodeship | 40-282 | Poland |
| Hallym University Dongtan Sacred Heart Hospital | Recruiting | Hwaseong-si | Kyǒnggi-do | 18450 | South Korea |
| Ewha Womans University Seoul Hospital | Recruiting | Gangseo-gu | Seoul-teukbyeolsi [seoul] | 07804 | South Korea |
| Nowon Eulji Medical Center, Eulji University | Recruiting | Seoul | Seoul-teukbyeolsi [seoul] | 01830 | South Korea |
| Kangbuk Samsung Hospital | Recruiting | Seoul | Seoul-teukbyeolsi [seoul] | 03181 | South Korea |
| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | Seoul-teukbyeolsi [seoul] | 03722 | South Korea |
| Hospital Clínic de Barcelona | Recruiting | Barcelona | Barcelona [barcelona] | 08036 | Spain |
| Hospital Universitario Marqués de Valdecilla | Recruiting | Santander | Cantabria | 39008 | Spain |
| FutureMeds Spain Cádiz | Recruiting | Chiclana de la Frontera | Cádiz | 11139 | Spain |
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital La Princesa | Recruiting | Madrid | 28006 | Spain |
| Hospital Universitario La Paz | Recruiting | Madrid | 28046 | Spain |
| Hospital Universitario Virgen Del Rocio | Recruiting | Seville | 41013 | Spain |
| Hospital Clínico Universitario de Valladolid | Recruiting | Valladolid | 47010 | Spain |
| Hospital Clínico Universitario Lozano Blesa | Recruiting | Zaragoza | 50009 | Spain |
| West Walk Surgery | Recruiting | Bristol | Bristol, CITY of | BS37 4AX | United Kingdom |
| Bioluminux | Recruiting | Milton Keynes | Buckinghamshire | MK15 0DU | United Kingdom |
| Hull University Teaching Hospitals NHS Trust | Recruiting | Hull | EAST Yorkshire | HU3 2JZ | United Kingdom |
| Re:Cognition Health - London | Recruiting | London | England | W1G 8TA | United Kingdom |
| The Walton Centre NHS Foundation Trust | Recruiting | Fazakerley | Liverpool | L9 7LJ | United Kingdom |
| Panthera Clinic - York | Recruiting | York | North Yorkshire | YO24 4LJ | United Kingdom |
| Panthera Biopartners - Glasgow | Recruiting | Glasgow | Scotland | G51 4TY | United Kingdom |
| Panthera Biopartners - Sheffield | Recruiting | Sheffield | S2 5FX | United Kingdom |
| ID | Term |
|---|---|
| C578443 | rimegepant sulfate |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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