NCT05509400CompletedPhase 4
Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use
BHV3000-406 (C4951004): A Phase 4, Randomized, Double-blind Placebo-Controlled, Efficacy and Tolerability Trial of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use
Source: ClinicalTrials.gov · Last updated 21 Apr 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 813 (actual)
- First submitted
- 18 Aug 2022
- Start date
- 18 Oct 2022
- Primary completion date
- 10 Mar 2025
- Lead sponsor
- Pfizer
- Diseases
- Migraine
- NCT number
- NCT05509400
- EU CT number
- 2024-513269-37-00
- EudraCT number
- 2022-001175-14
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 813
- From 18 Oct 2022 to the primary completion date, 10 Mar 2025
- 99 sites in 15 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current medication overuse headaches
- Headaches occurring 15 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit
Other illness
- -Target Disease Exclusion:
- History of cluster headache, basilar migraine, or hemiplegic migraine
- Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome \[CRPS\])
- Other pain syndromes (including trigeminal neuralgia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, interfere with study assessments of safety or efficacy
Who the study is looking for
- Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
- Migraine attacks, on average, lasting about 4 - 72 hours if untreated.
- 4 to 14 migraine days per month on average across the 3 months prior to the Screening Visit (month is defined as 28 days for the purpose of this protocol).
- Less than 15 headache days (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and throughout the Screening Phase.
- Subjects must be able to distinguish migraine attacks from tension/cluster headaches.
- Subjects on prophylactic migraine medication (excluding CGRP antagonists) are permitted to remain on therapy if they have been on a stable dose for at least 3 months (12 weeks) prior to the Screening Visit, and if the dose is not expected to change during the course of the study.
- Triptan unsuitable
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (99)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Completed |
| Klinikum Klagenfurt am Wörthersee Coordinator of this site? Confirm its status | Klagenfurt am Wörthersee | Austria | Completed |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Completed |
| Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| USC Clinical Trials Centre Coordinator of this site? Confirm its status | Sippy Downs | Australia | Unknown status |
| GasthuisZusters Antwerpen Coordinator of this site? Confirm its status | Antwerp | Belgium | Completed |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Completed |
| JESSA Ziekenhuis Coordinator of this site? Confirm its status | Hasselt | Belgium | Completed |
| UZ Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Completed |
| Céphalées et Migraines Neurologie Générale EMG Electromyographie EEG Electroencéphalographie Coordinator of this site? Confirm its status | Saint Nicolas | Belgium | Completed |
| Aggarwal and Associates Limited Coordinator of this site? Confirm its status | Brampton | Canada | Unknown status |
| University of Calgary South Health Campus Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Clinique Neuro-Lévis Coordinator of this site? Confirm its status | Lévis | Canada | Unknown status |
| Alpha Recherche Clinique Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Kopfschmerzzentrum Frankfurt Coordinator of this site? Confirm its status | Frankfurt a. M. | Germany | Completed |
| Universitaetsmedizin Greifswald KöR Coordinator of this site? Confirm its status | Greifswald | Germany | Completed |
| Universitaetsklinikum Jena KöR Coordinator of this site? Confirm its status | Jena | Germany | Completed |
| Vitos Orthopaedische Klinik Kassel gGmbH Coordinator of this site? Confirm its status | Kassel | Germany | Completed |
| Schmerzklinik Kiel Gmbh & Co. KG Klinik fuer neurologisch-verhaltensmedizinische Schmerztherapie Coordinator of this site? Confirm its status | Kiel | Germany | Completed |
| DKD HELIOS Klinik Wiesbaden GmbH Coordinator of this site? Confirm its status | Wiesbaden | Germany | Completed |
| Bispebjerg Hospital Coordinator of this site? Confirm its status | Copenhagen Nv | Denmark | Completed |
| Esbjerg Og Grindsted Sygehus Coordinator of this site? Confirm its status | Esbjerg | Denmark | Completed |
| Rigshospitalet Coordinator of this site? Confirm its status | Glostrup | Denmark | Completed |
| Regionshospitalet Viborg Coordinator of this site? Confirm its status | Viborg | Denmark | Completed |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Hospital Ruber Juan Bravo Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Hospital Clinico Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Completed |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Completed |
| Suomen Terveystalo Oy Coordinator of this site? Confirm its status | Helsinki | Finland | Completed |
| Suomen Terveystalo Oy Coordinator of this site? Confirm its status | Tampere | Finland | Completed |
| Suomen Terveystalo Oy Coordinator of this site? Confirm its status | Turku | Finland | Completed |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Completed |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont Ferrand Cedex 1 | France | Completed |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Completed |
| Timone University Hospital Coordinator of this site? Confirm its status | Marseille | France | Completed |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Completed |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Completed |
| Centre Hospitalier Annecy Genevois Coordinator of this site? Confirm its status | Pringy Cedex | France | Completed |
| Centre Hospitalier Universitaire de Saint Etienne Coordinator of this site? Confirm its status | Saint-Priest-en-Jarez | France | Completed |
| Lakeside Healthcare Group Research Coordinator of this site? Confirm its status | Corby | United Kingdom | Unknown status |
| Re: Cognition Health Ltd. Coordinator of this site? Confirm its status | Edgebaston | United Kingdom | Unknown status |
| 4 Medical Clinical Solutions London Coordinator of this site? Confirm its status | Ilford | United Kingdom | Unknown status |
| Kings College London Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| 4 Medical Clinical Solutions Coordinator of this site? Confirm its status | Swinton | United Kingdom | Unknown status |
| Policlinico di Bari Coordinator of this site? Confirm its status | Bari | Italy | Completed |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Policlinico di Modena Coordinator of this site? Confirm its status | Modena | Italy | Completed |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Completed |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Completed |
| Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Irccs San Raffaele Roma S.r.l. Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Centro de Investigación Médica de Aguascalientes (CIMA) Coordinator of this site? Confirm its status | Aguascalientes | Mexico | Unknown status |
| Clinstile SA de CV Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Operadora Unidad de Investigación En Salud de Chihuahua, Sa de Cv Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Clinical Research Institute S.C. Coordinator of this site? Confirm its status | Tlalnepantla | Mexico | Unknown status |
| Centrum Medyczne Neuromed Sp. z.o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Completed |
| Vita Longa Sp. Z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Completed |
| Headache Management Centre Dr Lukasz Kmieciak Coordinator of this site? Confirm its status | Łódź | Poland | Completed |
| Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Nowa Sol | Poland | Completed |
| Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K. Coordinator of this site? Confirm its status | Oswiecim | Poland | Completed |
| Medicover Integrated Clinical Services Sp. z o.o. Coordinator of this site? Confirm its status | Szczecin | Poland | Completed |
| Centrum Medyczne Damiana Holding Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| MTZ Clinical Research powered by Pratia Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Clinirem Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Dr Sekowska Leczenie Bolu Coordinator of this site? Confirm its status | Warszawa | Poland | Completed |
| MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak Coordinator of this site? Confirm its status | Wroclaw | Poland | Completed |
| Skaneuro AB Coordinator of this site? Confirm its status | Lund | Sweden | Completed |
| CTC Clinical Trial Consultants AB Coordinator of this site? Confirm its status | Solna | Sweden | Completed |
| Akardo AB Coordinator of this site? Confirm its status | Stockholm | Sweden | Completed |
| Halsoklustret AB Coordinator of this site? Confirm its status | Stockholm | Sweden | Completed |
| CTC Clinical Trial Consultants AB Coordinator of this site? Confirm its status | Uppsala | Sweden | Completed |
| Synexus Clinical Research US, Inc. - Anderson Coordinator of this site? Confirm its status | Anderson | United States | Unknown status |
| Michigan Headache & Neurological Institute Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Northwest Clinical Research Center Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Boston Clinical Trials Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| DM Clinical Research - NY, NY Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| Headache Wellness Center, PC Coordinator of this site? Confirm its status | Greensboro | United States | Unknown status |
| Wr-Msra,Llc Coordinator of this site? Confirm its status | Lake City | United States | Unknown status |
| Red Star Research, LLC Coordinator of this site? Confirm its status | Lake Jackson | United States | Unknown status |
| Clinical Research Institute Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Community Clinical Research Network, Inc. Coordinator of this site? Confirm its status | Marlborough | United States | Unknown status |
| Delricht Research Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| New York Neurology Associates Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Sensible Healthcare, LLC Coordinator of this site? Confirm its status | Ocoee | United States | Unknown status |
| Sandhill Research, LLC d/b/a Accel Research Sites Network - Ormond Clinical Research Unit Coordinator of this site? Confirm its status | Ormond Beach | United States | Unknown status |
| Collective Medical Research Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
| Rochester Medical Group Coordinator of this site? Confirm its status | Rochester Hills | United States | Unknown status |
| WR-Mount Vernon Clinical Research, LLC Coordinator of this site? Confirm its status | Sandy Springs | United States | Unknown status |
| DM Clinical Research - Detroit Coordinator of this site? Confirm its status | Southfield | United States | Unknown status |
| Clinvest Research, LLC Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Ki Health Partners, LLc, dba New England Institute for Clinical Research Coordinator of this site? Confirm its status | Stamford | United States | Unknown status |
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| DM Clinical Research Coordinator of this site? Confirm its status | Tomball | United States | Unknown status |
| St. Charles Clinical Research Coordinator of this site? Confirm its status | Weldon Spring | United States | Unknown status |
Related publications
- Time Course of Rimegepant Effect for Acute Treatment of Migraine in Adults Unsuitable for Triptans: Exploratory Endpoints from a Phase 4, Randomized, Double-Blind, Placebo-Controlled Study.Neurol Ther · 2026 · PMID 42828704
- 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 · PMID 41930741
- Rimegepant for acute treatment of migraine in triptan-unsuitable adults: A randomized, double-blind, placebo-controlled phase 4 trial.Cephalalgia · 2025 · PMID 41255093
This page is information, not medical advice. Discuss any trial with your doctor.