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| ID | Type | Description | Link |
|---|---|---|---|
| C4951004 | Other Identifier | Alias Study Number | |
| 2022-001175-14 | Registry Identifier | CTIS (EU) | |
| 2024-513269-37-00 | Registry Identifier | CTIS (EU) |
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This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease).
This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease). Rimegepant will be further evaluated in this population with as needed use in a 12-week, open-label extension study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rimegepant | Experimental | Rimegepant - Double-blind (DB) Phase: One dose of rimegepant 75 mg Oral Disintegrating Tablet (ODT) Rimegepant/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT as needed for a qualifying acute migraine. A qualifying migraine is an attack of moderate or severe headache pain intensity. Migraine headache pain intensity will be measured on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe) |
|
| Placebo | Placebo Comparator | Placebo - Double-blind (DB) Phase: One dose of matching placebo Placebo/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT for a qualifying migraine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimegepant | Drug | DB Phase: Rimegepant 75 mg Orally Disintegrating Tablet (ODT) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Pain Relief at 2 Hours Post-Dose: DBT Phase | Participants recorded their migraine headache pain intensity using 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe). Pain relief at 2 hours post-dose was defined as pain intensity of none or mild at that time point. | At 2 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Pain Freedom at 2 Hours Post-Dose: DBT Phase | Participants recorded their migraine headache pain intensity using 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe). Pain freedom at 2 hours post-dose was a pain intensity of none at that time point. | At 2 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
-Target Disease Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Institute | Los Angeles | California | 90048 | United States | ||
| Ki Health Partners LLC, dba New England Institute for Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41930741 | Derived | Ashina M, McAllister P, Gaul C, Leyva-Rendon A, Ramirez LM, Nalpas C, Thiry A, Abraham L, Fountaine RJ, Fullerton T. Can rimegepant stop symptoms of a migraine attack in people who have not found triptans to work well or are not recommended to use triptans? A plain language summary of a clinical study. Pain Manag. 2026 Jun;16(6):551-565. doi: 10.1080/17581869.2026.2646705. Epub 2026 Apr 3. | |
| 41255093 |
| 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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A total of 813 participants were enrolled in the study, out of these 180 participants were not randomized. Only 633 participants were randomized. A total of 585 participants were treated with study intervention in double-blind treatment (DBT) phase. Then, 555 participants continued into open label extension (OLE) phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | DB Rimegepant/ OL Rimegepant | Participants administered rimegepant 75 milligrams (mg) in DBT phase (DB rimegepant), orally as an orally disintegrating tablet (ODT) only once when they experienced a migraine headache of moderate to severe intensity up to 45 days after randomization. Eligible participants could take up to 1 tablet of ODT rimegepant 75 mg in OLE phase (OL rimegepant) per calendar day as needed for acute treatment of migraine for a maximum of 18 doses per month (month= 28 days). Participants who received rimegepant 75 mg in DBT phase or in DBT and OLE phases and were followed up for safety for 2 weeks post discontinuation or completion of OLE phase. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| DBT Phase |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 5, 2024 | Mar 6, 2026 |
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| Placebo |
| Drug |
DB Phase: matching placebo |
|
| Rimegepant | Drug | OLE Phase: Rimegepant 75 mg ODT in association with each of the first 5 qualifying migraines |
|
| Percentage of Participants Who Used Rescue Medications Within 24 Hours Post-Dose: DBT Phase |
Post 24 hours after dosing with study medication and after the 24-hour assessments were completed on the e-diary, participants were permitted to use the following rescue medications (non-study medications) such as: 1) non-steroidal anti-inflammatory drug like acetaminophen or aspirin, ibuprofen, naproxen; 2) antiemetics like metoclopramide, promethazine; 3) other like baclofen; 4) other approved pharmacological treatment with established efficacy in the acute treatment of migraine, including locally recognized standard of care, unless otherwise specified. |
| Within 24 hours post-dose |
| Percentage of Participants With Return to Normal Function at 2 Hours Post-Dose: DBT Phase | Functional disability level was measured on a 4-point numeric rating scale (0= normal,1= mildly impaired, 2= severely impaired, 3= required bedrest). Functional disability was defined as a functional disability level of mildly impaired, severely impaired, or required bedrest. Return to normal function at 2 hours post-dose was defined as functional disability score of normal at that time point for participants with functional disability at the time of dosing. | At 2 hours post-dose |
| Percentage of Participants With Sustained Return to Normal Function From 2 to 24 Hours Post-Dose: DBT Phase | Functional disability level was measured on a 4-point numeric rating scale (0= normal,1= mildly impaired, 2= severely impaired, 3= required bedrest). Functional disability was defined as a functional disability level of mildly impaired, severely impaired, or required bedrest. Sustained return to normal function, from 2 to 24 hours post-dose was defined as functional disability levels of normal at all time points from 2 to 24 hours post-dose in participants with functional disability at the time of dosing. | From 2 to 24 hours post-dose |
| Percentage of Participants With Sustained Return to Normal Function From 2 to 48 Hours Post-Dose: DBT Phase | Functional disability level was measured on a 4-point numeric rating scale (0= normal,1= mildly impaired, 2= severely impaired, 3= required bedrest). Functional disability was defined as a functional disability level of mildly impaired, severely impaired, or required bedrest. Sustained return to normal function, from 2 to 48 hours post-dose was defined as functional disability levels of normal at all time points from 2 to 48 hours post-dose in participants with functional disability at the time of dosing. | From 2 to 48 hours post-dose |
| Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-Dose: DBT Phase | Participants recorded their migraine headache pain intensity using 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe). Sustained pain relief from 2 to 24 hours post-dose was defined as a pain intensity of none or mild at all time points from 2 to 24 hours post-dose. | From 2 to 24 hours post-dose |
| Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-Dose: DBT Phase | Participants recorded their migraine headache pain intensity using 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe). Sustained pain relief from 2 to 48 hours post-dose was defined as a pain intensity of none or mild at all time points from 2 to 48 hours post-dose. | From 2 to 48 hours post-dose |
| Percentage of Participants With Sustained Freedom From Pain From 2 to 24 Hours Post-Dose: DBT Phase | Participants recorded their migraine headache pain intensity using 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe). Sustained pain freedom from 2 to 24 hours post-dose was defined as a pain intensity of none at all time points from 2 to 24 hours post-dose. | From 2 to 24 hours post-dose |
| Percentage of Participants With Sustained Freedom From Pain From 2 to 48 Hours Post-Dose: DBT Phase | Participants recorded their migraine headache pain intensity using 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe). Sustained pain freedom from 2 to 48 hours post-dose was defined as a pain intensity of none at all time points from 2 to 48 hours post-dose. | From 2 to 48 hours post-dose |
| Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-Dose: DBT Phase | MBS freedom was defined as MBS reported before dosing that was absent post-dose at the specified time point. MBS reported before dosing was nausea, photophobia, or phonophobia. Each symptom (nausea, photophobia, or phonophobia) was measured post-dose using 0= absent or 1= present. Participants who had symptom score of 0 (absent) aligning with MBS reported before dosing were considered to have MBS freedom. | At 2 hours post-dose |
| Reliability of Rimegepant Effect in the OLE Phase Based on Evaluable Qualifying Migraine Attacks (EQMA) of DBT and OLE Phase | Reliability of rimegepant effect during OLE Phase achieved when difference between (1) percentage of participants randomized to rimegepant with response to single EQMA in DBT phase and(2) percentage of participants with response to >=4 of first 5 EQMAs >=23 hours(h) apart in OLE phase was <=7%. Statistical analysis reports difference between (1) and (2) for each first 5 EQMAs >=23h apart in OLE phase. Response: category of "moderately better" or"very much better" for Migraine Quality of Life Questionnaire(MQoL)Question(Q) 16 (overall change in migraine symptoms since taking study medication) at 24h post-dose. EQMA:evaluable qualifying migraine attack (migraine attack of moderate/severe pain intensity,first treated with rimegepant, not other acute headache medication) with nonmissing MQoL Q16 value at 24h post dose. Percentage of participants with response after single EQMA in DBT phase randomized to rimegepant and each of first 5 EQMA in OLE phase are reported in descriptive section. | DBT phase: up to maximum 45 days; OLE phase: up to maximum of 12 weeks |
| Mean Change From Historical Baseline in Number of Migraine Days Per Month by Headache Pain Intensity at Months 1, 2 and 3 and Overall: OLE Phase | Mean change from historical baseline in the number of migraine days per month by headache pain intensity (total; moderate or severe) at each specified month and over the entire OLE Phase is reported in this outcome measure. A migraine day was defined as either 1) a day on which participant experienced migraine headache pain intensity of mild, moderate, or severe as reported in eDiary or 2) an acute migraine-specific medication day. Total historical baseline is defined as the number of migraine days per month of any pain intensity in the 3 months prior to screening from the migraine history case report form (CRF). Moderate or severe historical baseline was defined as the number of migraine days per month of moderate or severe pain intensity in the 3 months prior to screening from the migraine history CRF. | Baseline (3 months prior to Screening); Month 1 (OLE Days 1 to 28), Month 2 (OLE Days 29 to 56) and Month 3 (OLE Days 57 to 84), and Overall OLE phase (84 days) |
| Percentage of Participants With at Least 50% Reduction From Historical Baseline in the Number of Migraine Days Per Month by Headache Pain Intensity at Months 1, 2 and 3 and Overall: OLE Phase | Percentages of participants with >= 50% reduction from historical baseline in the number of migraine days per month by headache pain intensity (total; moderate or severe) in each month and over the entire OLE Phase is reported in this outcome measure. A migraine day was defined as either 1) a day on which participant experienced migraine headache pain intensity of mild, moderate, or severe as reported in eDiary or 2) an acute migraine-specific medication day. Total historical baseline is defined as the number of migraine days per month of any pain intensity in the 3 months prior to screening from the migraine history CRF. Moderate or severe historical baseline was defined as the number of migraine days per month of moderate or severe pain intensity in the 3 months prior to screening from the migraine history CRF. | Baseline (3 months prior to Screening); Month 1 (OLE Days 1 to 28), Month 2 (OLE Days 29 to 56) and Month 3 (OLE Days 57 to 84), and Overall OLE phase (84 days) |
| Number of Participants With Adverse Events (AEs) by Intensity: DBT Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participants or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with the treatment. AE intensity included mild, moderate and severe. Mild AE was defined as AEs which is usually transient and required only minimal treatment or therapeutic intervention. The event did not generally interfere with usual activities of daily living. Moderate AE was defined as AEs which was usually alleviated with additional specific therapeutic intervention. The event interfered with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the participants. Severe AE was defined as AE that interrupted with usual activities of daily living, significantly affected clinical status, or required intensive therapeutic intervention. | DBT Phase: maximum of 45 days |
| Number of Participants With Serious AEs: DBT Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participants or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with the treatment. A serious AE is any event that met any of the following criteria at any dose: death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a participant who received rimegepant or other important medical events. | DBT Phase: maximum of 45 days |
| Number of Participants With AEs Leading to Study Drug Discontinuation: DBT Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participants or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with the treatment. Number of participants with AEs leading to study drug discontinuation have been reported in this outcome measure. | DBT Phase: maximum of 45 days |
| Number of Participants With Any On-Treatment Grade 3 to 4 Laboratory Abnormalities: DBT Phase | Laboratory tests included hematology and serum chemistry. All laboratory tests except glucose were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0, where Grade 3=severe events which require hospitalization or prolongation of hospitalization and Grade 4=life-threatening consequences requiring urgent intervention. Glucose was graded according to Division of Acquired Immune Deficiency Syndrome table for Grading Severity of Adult and Pediatric Adverse Events v2.1. | DBT Phase: maximum of 45 days |
| Number of Participants With AEs by Intensity: OLE Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participants or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with the treatment. AE intensity included mild, moderate and severe. Mild AE was defined as AEs which is usually transient and required only minimal treatment or therapeutic intervention. The event did not generally interfere with usual activities of daily living. Moderate AE was defined as AEs which was usually alleviated with additional specific therapeutic intervention. The event interfered with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the participants. Severe AE was defined as AE that interrupted with usual activities of daily living, significantly affected clinical status, or required intensive therapeutic intervention. | OLE Phase: maximum up to 12 weeks |
| Number of Participants With Serious AEs: OLE Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participants or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with the treatment. A serious AE is any event that met any of the following criteria at any dose: death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a participant who received rimegepant or other important medical events. | OLE Phase: maximum up to 12 weeks |
| Number of Participants With AEs Leading to Study Drug Discontinuation: OLE Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participants or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with the treatment. Number of participants with AEs leading to study drug discontinuation have been reported in this outcome measure. | OLE Phase: maximum up to 12 weeks |
| Number of Participants With On-Treatment Grade 3 to 4 Laboratory Abnormalities: OLE Phase | Laboratory tests included hematology and serum chemistry. All laboratory tests except glucose were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0, where Grade 3=severe events which require hospitalization or prolongation of hospitalization and Grade 4=life-threatening consequences requiring urgent intervention. Glucose was graded according to Division of Acquired Immune Deficiency Syndrome table for Grading Severity of Adult and Pediatric Adverse Events v2.1. | OLE Phase: maximum up to 12 weeks |
| Mean Change From Baseline in the Migraine Interictal Burden Scale (MIBS) Score at Weeks 4, 8, and 12: OLE Phase | MIBS was a 4-item self-administered questionnaire that measured interictal migraine related burden in the past 4 weeks on days when participants were not having an attack, using 4 domains: impairment in work or school; impairment in family and social life; difficulty making plans or commitments; emotional/affective and cognitive distress. The questionnaire specifically asked about the effect of the disease over the past 4 weeks on days without a headache attack. Response options included: don't know/not applicable (0), never (0), rarely (1), some of the time (2), much of the time (3), or most or all of the time (3). Each response associated with numerical score were summed across all 4 items resulting in a total MIBS score ranging from 0 to 12, and the level of interictal burden being categorized into the following: 0 for none and 12 for severe. Higher scores indicate worse interictal burden. | OLE phase: Baseline; Week 4, Week 8 and Week 12 |
| Stamford |
| Connecticut |
| 06905 |
| United States |
| Wr-Msra, Llc | Lake City | Florida | 32055 | United States |
| Sensible Healthcare LLC | Ocoee | Florida | 34761 | United States |
| Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research Unit | Ormond Beach | Florida | 32174 | United States |
| WR-Mount Vernon Clinical Research, LLC | Sandy Springs | Georgia | 30328 | United States |
| Collective Medical Research | Overland Park | Kansas | 66210 | United States |
| DelRicht Research | New Orleans | Louisiana | 70115 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| Community Clinical Research Network Inc | Marlborough | Massachusetts | 01752 | United States |
| Michigan Headache & Neurological Institute | Ann Arbor | Michigan | 48104 | United States |
| Rochester Medical Group | Rochester Hills | Michigan | 48307 | United States |
| DM Clinical Research - Detroit | Southfield | Michigan | 48076 | United States |
| Clinvest Research, LLC | Springfield | Missouri | 65807 | United States |
| St Charles Clinical Research | Weldon Spring | Missouri | 63304 | United States |
| DM Clinical Research - NY, NY | Brooklyn | New York | 11220 | United States |
| New York Neurology Associates | New York | New York | 10003 | United States |
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
| Headache Wellness Center, PC | Greensboro | North Carolina | 27405 | United States |
| Synexus Clinical Research US, Inc. - Anderson | Anderson | South Carolina | 29621 | United States |
| Red Star Research, LLC | Lake Jackson | Texas | 77566 | United States |
| DM Clinical Research | Tomball | Texas | 77375 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| USC Clinical Trials Centre | Sippy Downs | Queensland | 4556 | Australia |
| Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Klinikum Klagenfurt am Wörthersee | Klagenfurt | Carinthia | 9020 | Austria |
| Medical University Innsbruck | Innsbruck | Tyrol | 6020 | Austria |
| Cabinet Privé Dr. Simona Sava | Saint-Nicolas | Liège | 4420 | Belgium |
| GZA Ziekenhuizen | Antwerp | 2610 | Belgium |
| UZ Brussel | Brussels | 1090 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| Jessa Ziekenhuis | Hasselt | 3500 | Belgium |
| University of Calgary South Health Campus | Calgary | Alberta | T3M 1M4 | Canada |
| Aggarwal and Associates Limited | Brampton | Ontario | L6T 0G1 | Canada |
| Clinique Neuro-Lévis | Lévis | Quebec | G6W 0M5 | Canada |
| Alpha Recherche Clinique | Québec | Quebec | G3K 2P8 | Canada |
| ALPHA Recherche Clinique | Québec | G2J 0C4 | Canada |
| University Hospital of Southern Denmark | Esbjerg | DK-6700 | Denmark |
| Danish Headache Center | Glostrup Municipality | 2600 | Denmark |
| Hospitalsenhed Midt | Viborg | DK-8800 | Denmark |
| Helsinki Headache Center | Helsinki | Uusimaa | 00830 | Finland |
| Terveystalo Ruoholahti | Helsinki | Finland |
| Terveystalo Tampere Rautatienkatu | Tampere | 33100 | Finland |
| Terveystalo Pulssi | Turku | 20100 | Finland |
| Timone Hospital | Marseille | Provence | 13005 | France |
| Hospices Civils de Lyon - Hôpital Neurologique Pierre Wertheimer | Bron | 69500 | France |
| CHU Clermont Ferrand - Hopital Gabriel Montpied | Clermont-Ferrand | 63000 | France |
| Centre Hospitalier Annecy Genevois | Epagny Metz-Tessy | 74370 | France |
| CHU de Lille - Hôpital Salengro | Lille | 59037 | France |
| CHU Nice Hopital Cimiez | Nice | 06000 | France |
| Hopital Lariboisiere | Paris | 75010 | France |
| CHU Saint-Etienne - Hopital Nord | Saint-Etienne | 42055 | France |
| Neurologische Praxis Prof. Dr. Hartmut Gobel | Kiel | Schleswig-Holstein | D-24149 | Germany |
| University Hospital Jena | Jena | Thuringia | 07747 | Germany |
| Charité Universitätsmedizin Berlin, Neurologische Ambulanz, Kopfschmerzambulanz | Berlin | 10117 | Germany |
| Kopfschmerzzentrum Frankfurt | Frankfurt | 65929 | Germany |
| IRCCS Ospedale San Raffaele | Milan | MI | 20132 | Italy |
| AOU Luigi Vanvitelli | Naples | Naples | 80138 | Italy |
| Fondazione Policlinico Campus BioMedico | Rome | RM | 00128 | Italy |
| Foundation IRCCS Neurological Institute Carlo Besta | Milan | 20133 | Italy |
| AOU Policlinico di Modena | Modena | 41124 | Italy |
| Fondazione Mondino - Istituto Neurologico Nazionale IRCCS | Pavia | 27100 | Italy |
| Headache and Pain Unit - IRCCS San Raffaele | Rome | 00163 | Italy |
| Clinical Research Institute S.C. | Tlalnepantla | State of Mexico | 54055 | Mexico |
| Centro de Investigación Médica de Aguascalientes (CIMA) | Aguascalientes | 20116 | Mexico |
| Operadora Unidad de Investigación En Salud de Chihuahua, Sa de Cv | Mexico City | 14050 | Mexico |
| Clinstile SA de CV | Mexico City | CDMX 06700 | Mexico |
| Centrum Medyczne Neuromed | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-163 | Poland |
| MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak | Wroclaw | Lower Silesian Voivodeship | 52-210 | Poland |
| Twoja Przychodnia Nowosolskie Centrum Medyczne | Nowa Sól | Lubusz Voivodeship | 67-100 | Poland |
| Concept Medica | Warsaw | Masovian Voivodeship | 00-773 | Poland |
| MICS Centrum Medyczne Damiana Walbrzyska | Warsaw | Masovian Voivodeship | 02-739 | Poland |
| Instytut Zdrowia dr Boczarska-Jedynak Sp. z o.o. Sp. k. | Oświęcim | Małopolska | 32-600 | Poland |
| Vita Longa Sp. Z o.o. | Katowice | 40-748 | Poland |
| MICS Centrum Medyczne Szczecin | Szczecin | 70-784 | Poland |
| Praktyka Lekarska | Warsaw | 00-144 | Poland |
| MTZ Clinical Research Powered by Pratia | Warsaw | 02-172 | Poland |
| Centrum Leczenia Bolu dr n med Lukasz Kmieciak | Lodz | Łódź Voivodeship | 91-363 | Poland |
| University Hospital Marqués de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Virgen del Rocio University Hospital | Seville | 41013 | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | 46010 | Spain |
| CTC Solna | Solna | Stockholms LÄN [se-01] | 171 64 | Sweden |
| CTC Uppsala | Uppsala | Uppsala County | 752 37 | Sweden |
| Skåneuro Privatmottagning | Lund | 222 22 | Sweden |
| Hälsoklustret | Stockholm | 112 39 | Sweden |
| Akardo MedSite | Stockholm | 117 27 | Sweden |
| Re: Cognition Health Ltd. | Edgebaston | Birmingham | B16 8LT | United Kingdom |
| 4 Medical Clinical Solutions London | Ilford | Essex | IG1 4HP | United Kingdom |
| Lakeside Healthcare Group Research | Corby | Northamptonshire | NN17 2UR | United Kingdom |
| Kings College London | London | WC2R 2LS | United Kingdom |
| 4 Medical Clinical Solutions | Swinton | M27 8FF | United Kingdom |
| Derived |
| Ashina M, McAllister P, Gaul C, Leyva-Rendon A, Ramirez LM, Nalpas C, Thiry A, Abraham L, Fountaine RJ, Fullerton T. Rimegepant for acute treatment of migraine in triptan-unsuitable adults: A randomized, double-blind, placebo-controlled phase 4 trial. Cephalalgia. 2025 Nov;45(11):3331024251395298. doi: 10.1177/03331024251395298. Epub 2025 Nov 18. |
| FG001 | DB Placebo/ OL Rimegepant | Participants administered placebo in DBT phase (DB placebo), orally as an ODT only once when they experienced a migraine headache of moderate to severe intensity up to 45 days after randomization. Participants could take up to 1 tablet of ODT rimegepant 75 mg in OLE phase (OL rimegepant) per calendar day as needed for acute treatment of migraine for a maximum of 18 doses per month (month= 28 days). Participants who received placebo in DBT phase and rimegepant 75 mg in OLE phase, were followed up for safety for 2 weeks post discontinuation or completion of OLE phase. |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| OLE Phase |
|
|
Safety analysis set (SAS) included participants in the enrolled analysis set who took >= 1 dose of study drug. Enrolled analysis set included participants who signed an informed consent form and were assigned a participant identification number, i.e., non-missing informed consent date.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | DB Rimegepant/ OL Rimegepant | Participants administered rimegepant 75 milligrams (mg) in DBT phase (DB rimegepant), orally as an orally disintegrating tablet (ODT) only once when they experienced a migraine headache of moderate to severe intensity up to 45 days after randomization. Eligible participants could take up to 1 tablet of ODT rimegepant 75 mg in OLE phase (OL rimegepant) per calendar day as needed for acute treatment of migraine for a maximum of 18 doses per month (month= 28 days). Participants who received rimegepant 75 mg in DBT phase or in DBT and OLE phases and were followed up for safety for 2 weeks post discontinuation or completion of OLE phase. |
| BG001 | DB Placebo/ OL Rimegepant | Participants administered placebo in DBT phase (DB placebo), orally as an ODT only once when they experienced a migraine headache of moderate to severe intensity up to 45 days after randomization. Participants could take up to 1 tablet of ODT rimegepant 75 mg in OLE phase (OL rimegepant) per calendar day as needed for acute treatment of migraine for a maximum of 18 doses per month (month= 28 days). Participants who received placebo in DBT phase and rimegepant 75 mg in OLE phase, were followed up for safety for 2 weeks post discontinuation or completion of OLE phase. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Here, "Number Analyzed" signifies participants evaluable for region for where Race was collected. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Here, "Number Analyzed" signifies participants evaluable for region for where Ethnicity was collected. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Pain Relief at 2 Hours Post-Dose: DBT Phase | Participants recorded their migraine headache pain intensity using 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe). Pain relief at 2 hours post-dose was defined as pain intensity of none or mild at that time point. | DBT efficacy analysis set included participants in the full analysis set (FAS) who met all the following criteria: 1) randomized only once; 2) took DB study drug; 3) had qualifying migraine attack at the time of DB study drug dosing and 4) had DB post-dose efficacy data. FAS: participants who signed an informed consent form and were assigned a participant identification number and who received a randomization treatment assignment. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 2 hours post-dose |
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| Secondary | Percentage of Participants With Pain Freedom at 2 Hours Post-Dose: DBT Phase | Participants recorded their migraine headache pain intensity using 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe). Pain freedom at 2 hours post-dose was a pain intensity of none at that time point. | DBT efficacy analysis set was analyzed. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 2 hours post-dose |
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| Secondary | Percentage of Participants Who Used Rescue Medications Within 24 Hours Post-Dose: DBT Phase | Post 24 hours after dosing with study medication and after the 24-hour assessments were completed on the e-diary, participants were permitted to use the following rescue medications (non-study medications) such as: 1) non-steroidal anti-inflammatory drug like acetaminophen or aspirin, ibuprofen, naproxen; 2) antiemetics like metoclopramide, promethazine; 3) other like baclofen; 4) other approved pharmacological treatment with established efficacy in the acute treatment of migraine, including locally recognized standard of care, unless otherwise specified. | DBT efficacy analysis set was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants with first DBT rescue medication date <= DB study drug date + 1 day and missing first DBT rescue medication time were excluded. | Posted | Number | 95% Confidence Interval | Percentage of participants | Within 24 hours post-dose |
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| Secondary | Percentage of Participants With Return to Normal Function at 2 Hours Post-Dose: DBT Phase | Functional disability level was measured on a 4-point numeric rating scale (0= normal,1= mildly impaired, 2= severely impaired, 3= required bedrest). Functional disability was defined as a functional disability level of mildly impaired, severely impaired, or required bedrest. Return to normal function at 2 hours post-dose was defined as functional disability score of normal at that time point for participants with functional disability at the time of dosing. | DBT efficacy analysis set was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure with functional disability at the time of DB study drug dosing. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 2 hours post-dose |
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| Secondary | Percentage of Participants With Sustained Return to Normal Function From 2 to 24 Hours Post-Dose: DBT Phase | Functional disability level was measured on a 4-point numeric rating scale (0= normal,1= mildly impaired, 2= severely impaired, 3= required bedrest). Functional disability was defined as a functional disability level of mildly impaired, severely impaired, or required bedrest. Sustained return to normal function, from 2 to 24 hours post-dose was defined as functional disability levels of normal at all time points from 2 to 24 hours post-dose in participants with functional disability at the time of dosing. | DBT efficacy analysis set was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure with functional disability at the time of DB study drug dosing. | Posted | Number | 95% Confidence Interval | Percentage of participants | From 2 to 24 hours post-dose |
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| Secondary | Percentage of Participants With Sustained Return to Normal Function From 2 to 48 Hours Post-Dose: DBT Phase | Functional disability level was measured on a 4-point numeric rating scale (0= normal,1= mildly impaired, 2= severely impaired, 3= required bedrest). Functional disability was defined as a functional disability level of mildly impaired, severely impaired, or required bedrest. Sustained return to normal function, from 2 to 48 hours post-dose was defined as functional disability levels of normal at all time points from 2 to 48 hours post-dose in participants with functional disability at the time of dosing. | DBT efficacy analysis set was analyzed. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure with functional disability at the time of DB study drug dosing. | Posted | Number | 95% Confidence Interval | Percentage of participants | From 2 to 48 hours post-dose |
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| Secondary | Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-Dose: DBT Phase | Participants recorded their migraine headache pain intensity using 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe). Sustained pain relief from 2 to 24 hours post-dose was defined as a pain intensity of none or mild at all time points from 2 to 24 hours post-dose. | DBT efficacy analysis set was analyzed. | Posted | Number | 95% Confidence Interval | Percentage of participants | From 2 to 24 hours post-dose |
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| Secondary | Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-Dose: DBT Phase | Participants recorded their migraine headache pain intensity using 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe). Sustained pain relief from 2 to 48 hours post-dose was defined as a pain intensity of none or mild at all time points from 2 to 48 hours post-dose. | DBT efficacy analysis set was analyzed. | Posted | Number | 95% Confidence Interval | Percentage of participants | From 2 to 48 hours post-dose |
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| Secondary | Percentage of Participants With Sustained Freedom From Pain From 2 to 24 Hours Post-Dose: DBT Phase | Participants recorded their migraine headache pain intensity using 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe). Sustained pain freedom from 2 to 24 hours post-dose was defined as a pain intensity of none at all time points from 2 to 24 hours post-dose. | DBT efficacy analysis set was analyzed. | Posted | Number | 95% Confidence Interval | Percentage of participants | From 2 to 24 hours post-dose |
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| Secondary | Percentage of Participants With Sustained Freedom From Pain From 2 to 48 Hours Post-Dose: DBT Phase | Participants recorded their migraine headache pain intensity using 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe). Sustained pain freedom from 2 to 48 hours post-dose was defined as a pain intensity of none at all time points from 2 to 48 hours post-dose. | DBT efficacy analysis set was analyzed. | Posted | Number | 95% Confidence Interval | Percentage of participants | From 2 to 48 hours post-dose |
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| Secondary | Percentage of Participants With Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-Dose: DBT Phase | MBS freedom was defined as MBS reported before dosing that was absent post-dose at the specified time point. MBS reported before dosing was nausea, photophobia, or phonophobia. Each symptom (nausea, photophobia, or phonophobia) was measured post-dose using 0= absent or 1= present. Participants who had symptom score of 0 (absent) aligning with MBS reported before dosing were considered to have MBS freedom. | DBT efficacy analysis set (EAS) was analyzed. | Posted | Number | 95% Confidence Interval | Percentage of participants | At 2 hours post-dose |
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| Secondary | Reliability of Rimegepant Effect in the OLE Phase Based on Evaluable Qualifying Migraine Attacks (EQMA) of DBT and OLE Phase | Reliability of rimegepant effect during OLE Phase achieved when difference between (1) percentage of participants randomized to rimegepant with response to single EQMA in DBT phase and(2) percentage of participants with response to >=4 of first 5 EQMAs >=23 hours(h) apart in OLE phase was <=7%. Statistical analysis reports difference between (1) and (2) for each first 5 EQMAs >=23h apart in OLE phase. Response: category of "moderately better" or"very much better" for Migraine Quality of Life Questionnaire(MQoL)Question(Q) 16 (overall change in migraine symptoms since taking study medication) at 24h post-dose. EQMA:evaluable qualifying migraine attack (migraine attack of moderate/severe pain intensity,first treated with rimegepant, not other acute headache medication) with nonmissing MQoL Q16 value at 24h post dose. Percentage of participants with response after single EQMA in DBT phase randomized to rimegepant and each of first 5 EQMA in OLE phase are reported in descriptive section. | DBT phase arm: participants in DBT EAS randomized to rimegepant with EQMA in DBT Phase analysis period were analyzed. OLE phase arm: participants in OLE EAS with EQMA (1 to 5) and >= 23 hours apart in OLE outcomes research analysis period were analyzed. "Overall Number of Participants Analyzed"=participants evaluable for this outcome measure and "Number Analyzed" = participants evaluable for specified rows. Number analyzed=0 where participants were not applicable for DB and OLE arm respectively. | Posted | Number | 95% Confidence Interval | Percentage of participants | DBT phase: up to maximum 45 days; OLE phase: up to maximum of 12 weeks |
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| Secondary | Mean Change From Historical Baseline in Number of Migraine Days Per Month by Headache Pain Intensity at Months 1, 2 and 3 and Overall: OLE Phase | Mean change from historical baseline in the number of migraine days per month by headache pain intensity (total; moderate or severe) at each specified month and over the entire OLE Phase is reported in this outcome measure. A migraine day was defined as either 1) a day on which participant experienced migraine headache pain intensity of mild, moderate, or severe as reported in eDiary or 2) an acute migraine-specific medication day. Total historical baseline is defined as the number of migraine days per month of any pain intensity in the 3 months prior to screening from the migraine history case report form (CRF). Moderate or severe historical baseline was defined as the number of migraine days per month of moderate or severe pain intensity in the 3 months prior to screening from the migraine history CRF. | Participants in the OLE efficacy analysis set with time in the OLE Phase >=14 days. Here, "Number Analyzed" signifies participants evaluable for specified row. | Posted | Mean | Standard Deviation | Migraine days per month | Baseline (3 months prior to Screening); Month 1 (OLE Days 1 to 28), Month 2 (OLE Days 29 to 56) and Month 3 (OLE Days 57 to 84), and Overall OLE phase (84 days) |
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| Secondary | Percentage of Participants With at Least 50% Reduction From Historical Baseline in the Number of Migraine Days Per Month by Headache Pain Intensity at Months 1, 2 and 3 and Overall: OLE Phase | Percentages of participants with >= 50% reduction from historical baseline in the number of migraine days per month by headache pain intensity (total; moderate or severe) in each month and over the entire OLE Phase is reported in this outcome measure. A migraine day was defined as either 1) a day on which participant experienced migraine headache pain intensity of mild, moderate, or severe as reported in eDiary or 2) an acute migraine-specific medication day. Total historical baseline is defined as the number of migraine days per month of any pain intensity in the 3 months prior to screening from the migraine history CRF. Moderate or severe historical baseline was defined as the number of migraine days per month of moderate or severe pain intensity in the 3 months prior to screening from the migraine history CRF. | Participants in the OLE efficacy analysis set with time in the OLE Phase >=14 days. Here, "Number Analyzed" signifies participants evaluable for specified row. | Posted | Number | Percentage of participants | Baseline (3 months prior to Screening); Month 1 (OLE Days 1 to 28), Month 2 (OLE Days 29 to 56) and Month 3 (OLE Days 57 to 84), and Overall OLE phase (84 days) |
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| Secondary | Number of Participants With Adverse Events (AEs) by Intensity: DBT Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participants or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with the treatment. AE intensity included mild, moderate and severe. Mild AE was defined as AEs which is usually transient and required only minimal treatment or therapeutic intervention. The event did not generally interfere with usual activities of daily living. Moderate AE was defined as AEs which was usually alleviated with additional specific therapeutic intervention. The event interfered with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the participants. Severe AE was defined as AE that interrupted with usual activities of daily living, significantly affected clinical status, or required intensive therapeutic intervention. | DB SAS: Participants in the enrolled analysis set who took >=1 dose of DB study drug (DB rimegepant, DB placebo). | Posted | Count of Participants | Participants | DBT Phase: maximum of 45 days |
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| Secondary | Number of Participants With Serious AEs: DBT Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participants or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with the treatment. A serious AE is any event that met any of the following criteria at any dose: death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a participant who received rimegepant or other important medical events. | DB SAS: Participants in the enrolled analysis set who took >= 1 dose of DB study drug (DB rimegepant, DB placebo). | Posted | Count of Participants | Participants | DBT Phase: maximum of 45 days |
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| Secondary | Number of Participants With AEs Leading to Study Drug Discontinuation: DBT Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participants or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with the treatment. Number of participants with AEs leading to study drug discontinuation have been reported in this outcome measure. | DB SAS: Participants in the enrolled analysis set who took >= 1 dose of DB study drug (DB rimegepant, DB placebo). | Posted | Count of Participants | Participants | DBT Phase: maximum of 45 days |
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| Secondary | Number of Participants With Any On-Treatment Grade 3 to 4 Laboratory Abnormalities: DBT Phase | Laboratory tests included hematology and serum chemistry. All laboratory tests except glucose were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0, where Grade 3=severe events which require hospitalization or prolongation of hospitalization and Grade 4=life-threatening consequences requiring urgent intervention. Glucose was graded according to Division of Acquired Immune Deficiency Syndrome table for Grading Severity of Adult and Pediatric Adverse Events v2.1. | DB SAS: Participants in enrolled analysis set who took >= 1 dose of DB study drug (DB rimegepant, DB placebo). Here, "Overall Number of Participants Analyzed" signifies participants in DB SAS, and "Number Analyzed' signifies participants in DB SAS with non-missing laboratory test data in on-DBT safety analysis duration. | Posted | Count of Participants | Participants | DBT Phase: maximum of 45 days |
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| Secondary | Number of Participants With AEs by Intensity: OLE Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participants or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with the treatment. AE intensity included mild, moderate and severe. Mild AE was defined as AEs which is usually transient and required only minimal treatment or therapeutic intervention. The event did not generally interfere with usual activities of daily living. Moderate AE was defined as AEs which was usually alleviated with additional specific therapeutic intervention. The event interfered with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the participants. Severe AE was defined as AE that interrupted with usual activities of daily living, significantly affected clinical status, or required intensive therapeutic intervention. | OL SAS: Participants in the enrolled analysis set who took >=1 dose of OL rimegepant. | Posted | Count of Participants | Participants | OLE Phase: maximum up to 12 weeks |
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| Secondary | Number of Participants With Serious AEs: OLE Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participants or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with the treatment. A serious AE is any event that met any of the following criteria at any dose: death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a participant who received rimegepant or other important medical events. | OL SAS: Participants in the enrolled analysis set who took >=1 dose of OL rimegepant. | Posted | Count of Participants | Participants | OLE Phase: maximum up to 12 weeks |
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| Secondary | Number of Participants With AEs Leading to Study Drug Discontinuation: OLE Phase | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participants or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with the treatment. Number of participants with AEs leading to study drug discontinuation have been reported in this outcome measure. | OL SAS: Participants in the enrolled analysis set who took >=1 dose of OL rimegepant. | Posted | Count of Participants | Participants | OLE Phase: maximum up to 12 weeks |
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| Secondary | Number of Participants With On-Treatment Grade 3 to 4 Laboratory Abnormalities: OLE Phase | Laboratory tests included hematology and serum chemistry. All laboratory tests except glucose were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0, where Grade 3=severe events which require hospitalization or prolongation of hospitalization and Grade 4=life-threatening consequences requiring urgent intervention. Glucose was graded according to Division of Acquired Immune Deficiency Syndrome table for Grading Severity of Adult and Pediatric Adverse Events v2.1. | OL SAS: Participants in enrolled analysis set who took >=1 dose of OL rimegepant. Here, "Overall Number of Participants Analyzed" signifies participants in OL SAS, and "Number Analyzed" signifies participants in OL SAS with non-missing laboratory test data in on-OL rimegepant safety analysis duration. | Posted | Count of Participants | Participants | OLE Phase: maximum up to 12 weeks |
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| Secondary | Mean Change From Baseline in the Migraine Interictal Burden Scale (MIBS) Score at Weeks 4, 8, and 12: OLE Phase | MIBS was a 4-item self-administered questionnaire that measured interictal migraine related burden in the past 4 weeks on days when participants were not having an attack, using 4 domains: impairment in work or school; impairment in family and social life; difficulty making plans or commitments; emotional/affective and cognitive distress. The questionnaire specifically asked about the effect of the disease over the past 4 weeks on days without a headache attack. Response options included: don't know/not applicable (0), never (0), rarely (1), some of the time (2), much of the time (3), or most or all of the time (3). Each response associated with numerical score were summed across all 4 items resulting in a total MIBS score ranging from 0 to 12, and the level of interictal burden being categorized into the following: 0 for none and 12 for severe. Higher scores indicate worse interictal burden. | Participants in the OLE efficacy analysis set with time in the OLE Phase >=14 days. Here, "Overall Number of Participants Analyzed" included participants evaluable for this outcome measure, all participants reported under "Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. | Posted | Mean | Standard Deviation | Scores on a scale | OLE phase: Baseline; Week 4, Week 8 and Week 12 |
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DBT Phase: maximum of 45 days; OLE Phase: maximum up to 12 weeks; Follow-up phase: 2 weeks after the discontinuation or completion of the OLE phase; Post-DBT Pre-OLE (Interim) phase: OL rimegepant start date - DB study drug date > 9 days (up to 13 weeks)
An event may appear as both AE and SAE if reported as distinct events. A participant may experience both. DB SAS: EAS participants who took >= 1 dose of DB rimegepant or placebo. OL SAS: EAS participants who took >=1 OL Rimegepant dose. Interim phase: Participants in OL rimegepant SAS with OL rimegepant start date-DB study drug date > 9 days. Follow-up SAS: participants in EAS who took >=1 dose of DB rimegepant, DB placebo, or OL rimegepant, whose last contact date was in follow-up SAS duration.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DB Rimegepant: DBT Phase | Participants who were administered rimegepant 75 mg orally as ODT single dose in DBT phase. | 0 | 295 | 0 | 295 | 116 | 295 |
| EG001 | DB Placebo: DBT Phase | Participants who were administered placebo orally as ODT single dose in DBT phase. | 0 | 290 | 0 | 290 | 20 | 290 |
| EG002 | DB Rimegepant/OL Rimegepant: Post-DBT Pre-OLE Phase | Participants administered rimegepant 75 mg ODT once in DBT phase (DB rimegepant) and entered the Post-DBT Pre-OLE phase (ie, > 9-day gap between DB study drug date and OL rimegepant start date). | 0 | 253 | 0 | 253 | 0 | 253 |
| EG003 | DB Placebo/OL Rimegepant: Post-DBT Pre-OLE Phase | Participants administered matching placebo for rimegepant 75 mg ODT once in DBT phase (DB placebo) and entered the Post-DBT Pre-OLE phase (ie, > 9-day gap between the DB study drug date and OL rimegepant start date). | 0 | 244 | 0 | 244 | 0 | 244 |
| EG004 | DB Rimegepant/ OL Rimegepant: OLE Phase | Participants were administered rimegepant 75 mg in DBT phase (DB rimegepant), orally as an ODT only once when they experienced a migraine headache of moderate to severe intensity up to 45 days after randomization. Eligible participants could take up to 1 tablet of ODT rimegepant 75 mg in OLE phase (OL rimegepant) per calendar day as needed for acute treatment of migraine for a maximum of 18 doses per month (month= 28 days). | 0 | 281 | 1 | 281 | 68 | 281 |
| EG005 | DB Placebo/ OL Rimegepant: OLE Phase | Participants were administered placebo in DBT phase (DB placebo), orally as an ODT only once when they experienced a migraine headache of moderate to severe intensity up to 45 days after randomization. Eligible participants could take up to 1 tablet of ODT rimegepant 75 mg in OLE phase (OL rimegepant) per calendar day as needed for acute treatment of migraine for a maximum of 18 doses per month (month= 28 days). | 0 | 271 | 1 | 271 | 56 | 271 |
| EG006 | DB Rimegepant/ OL Rimegepant: Follow-up Phase | Participants were administered rimegepant 75 mg in DBT phase (DB rimegepant), orally as an ODT only once when they experienced a migraine headache of moderate to severe intensity up to 45 days after randomization. Eligible participants could take up to 1 tablet of ODT rimegepant 75 mg in OLE phase (OL rimegepant) per calendar day as needed for acute treatment of migraine for a maximum of 18 doses per month (month= 28 days). Participants were followed up for safety for 2 weeks post discontinuation or completion of treatment in OLE phase. | 0 | 283 | 1 | 283 | 67 | 283 |
| EG007 | DB Placebo/ OL Rimegepant: Follow-up Phase | Participants were administered placebo in DBT phase (DB placebo), orally as an ODT only once when they experienced a migraine headache of moderate to severe intensity up to 45 days after randomization. Eligible participants could take up to 1 tablet of ODT rimegepant 75 mg in OLE phase (OL rimegepant) per calendar day as needed for acute treatment of migraine for a maximum of 18 doses per month (month= 28 days). Participants were followed up for safety for 2 weeks post discontinuation or completion of treatment in OLE phase. | 0 | 267 | 2 | 267 | 55 | 267 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA27.1 | Non-systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA27.1 | Non-systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA27.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA27.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA27.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA27.1 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 15, 2025 | Mar 6, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C578443 | rimegepant sulfate |
Not provided
Not provided
Not provided
| Other |
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Participants who were administered rimegepant 75 mg orally as ODT single dose in DBT phase. |
| OG001 | OL Rimegepant | All eligible participants (took DB rimegepant or DB placebo) received rimegepant 75 mg orally in OLE phase. |
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| OG001 | DB Placebo/ OL Rimegepant | Participants administered placebo in DBT phase (DB Placebo), orally as an ODT only once when they experienced a migraine headache of moderate to severe intensity up to 45 days after randomization. Eligible participants could take up to 1 tablet of ODT rimegepant 75 mg in OLE phase (OL Rimegepant) per calendar day as needed for acute treatment of migraine for a maximum of 18 doses per month (month= 28 days). |
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| OG001 | DB Placebo/ OL Rimegepant | Participants administered placebo in DBT phase (DB Placebo), orally as an ODT only once when they experienced a migraine headache of moderate to severe intensity up to 45 days after randomization. Eligible participants could take up to 1 tablet of ODT rimegepant 75 mg in OLE phase (OL Rimegepant) per calendar day as needed for acute treatment of migraine for a maximum of 18 doses per month (month= 28 days). |
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| OG001 | DB Placebo/ OL Rimegepant | Participants administered placebo in DBT phase (DB placebo), orally as an ODT only once when they experienced a migraine headache of moderate to severe intensity up to 45 days after randomization. Participants could take up to 1 tablet of ODT rimegepant 75 mg in OLE phase (OL rimegepant) per calendar day as needed for acute treatment of migraine for a maximum of 18 doses per month (month= 28 days). Participants who received placebo in DBT phase and rimegepant 75 mg in OLE phase, were followed up for safety for 2 weeks post discontinuation or completion of OLE phase. |
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| DB Placebo/ OL Rimegepant |
Participants administered placebo in DBT phase (DB placebo), orally as an ODT only once when they experienced a migraine headache of moderate to severe intensity up to 45 days after randomization. Participants could take up to 1 tablet of ODT rimegepant 75 mg in OLE phase (OL rimegepant) per calendar day as needed for acute treatment of migraine for a maximum of 18 doses per month (month= 28 days). Participants who received placebo in DBT phase and rimegepant 75 mg in OLE phase, were followed up for safety for 2 weeks post discontinuation or completion of OLE phase. |
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| OG001 | DB Placebo/ OL Rimegepant | Participants administered placebo in DBT phase (DB placebo), orally as an ODT only once when they experienced a migraine headache of moderate to severe intensity up to 45 days after randomization. Participants could take up to 1 tablet of ODT rimegepant 75 mg in OLE phase (OL rimegepant) per calendar day as needed for acute treatment of migraine for a maximum of 18 doses per month (month= 28 days). Participants who received placebo in DBT phase and rimegepant 75 mg in OLE phase, were followed up for safety for 2 weeks post discontinuation or completion of OLE phase. |
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| OG001 | DB Placebo/ OL Rimegepant | Participants administered placebo in DBT phase (DB placebo), orally as an ODT only once when they experienced a migraine headache of moderate to severe intensity up to 45 days after randomization. Participants could take up to 1 tablet of ODT rimegepant 75 mg in OLE phase (OL rimegepant) per calendar day as needed for acute treatment of migraine for a maximum of 18 doses per month (month= 28 days). Participants who received placebo in DBT phase and rimegepant 75 mg in OLE phase, were followed up for safety for 2 weeks post discontinuation or completion of OLE phase. |
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