Study on Rimegepant for Preventing Migraines in Adults with Poor Response to Oral Preventive Medications

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What is this study about?

This clinical trial is focused on studying migraine headaches, which are severe headaches that can occur with or without warning signs known as aura. The study is testing a treatment called Rimegepant, also known by its code name BHV-3000. Rimegepant is taken as an oral lyophilisate, which means it dissolves in the mouth. The purpose of the study is to evaluate how well Rimegepant works and how tolerable it is for preventing migraines in adults who have not had success with other oral preventive medications.

Participants in the study will be randomly assigned to receive either Rimegepant or a placebo, which looks like the medication but does not contain the active ingredient. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not biased. The study will last for several weeks, during which participants will take the medication every other day and report the number of migraine days they experience each month.

The main goal is to see if there is a reduction in the number of migraine days per month compared to before the study started. Additionally, the study will look at whether participants experience fewer days with moderate or severe headache pain and any changes in their ability to perform daily activities. The results will help determine if Rimegepant is an effective option for people who have not found relief with other migraine prevention treatments.

1 joining the study

Upon joining the study, eligibility is confirmed based on a history of migraines, with or without aura, and previous inadequate response to oral preventive medications.

Participants must have experienced migraines for more than one year, with attacks lasting 4 to 72 hours if untreated, and must be able to distinguish these from tension headaches.

2 observation phase

During this phase, the frequency of migraine days is recorded over a 28-day period.

This phase helps establish a baseline for comparison during the treatment phase.

3 double-blind treatment phase

Participants are randomly assigned to receive either rimegepant 75 mg or a placebo, administered orally every other day.

This phase lasts for 12 weeks, during which the number of migraine days is monitored.

4 evaluation of primary outcomes

The primary outcome is the change in the number of migraine days per month from the observation phase to the end of the treatment phase.

5 evaluation of secondary outcomes

Secondary outcomes include the proportion of participants with a 50% reduction in migraine days, changes in migraine days during specific weeks, and improvements in quality of life scores.

Who Can Join the Study?

  • Have a documented history of migraine headaches for at least 1 year. Migraines can occur with or without an aura, which are visual or sensory disturbances that some people experience before a migraine.
  • Must have had migraine attacks for more than 1 year before the screening visit.
  • The first migraine attack must have occurred before the age of 50.
  • Migraine attacks should last between 4 to 72 hours if not treated.
  • Experience between 4 to 14 migraine days per month on average in the 3 months before the screening visit.
  • Have between 4 to 14 migraine days during the 28-day observation phase of the study.
  • Be able to tell the difference between a migraine and a tension headache.
  • Have had an inadequate response to at least two to four different types of oral migraine-preventive medications in the past 10 years. This means the medications did not work well or caused side effects.
  • Be at least 18 years old.
  • Meet certain reproductive criteria, which will be explained in more detail in the study protocol.
  • If a woman of childbearing potential, must have a negative pregnancy test before starting the study medication.

Who Cannot Join the Study?

  • Patients who have a history of severe allergic reactions to the study medication or similar medications.
  • Individuals with other significant health conditions that might interfere with the study, such as uncontrolled high blood pressure or heart disease.
  • Women who are pregnant or breastfeeding.
  • Patients who are currently participating in another clinical trial.
  • Individuals who have used certain medications that might affect the study results within a specific time frame before the study starts.
  • Patients with a history of substance abuse or dependency.
  • Individuals who have had recent surgery or are planning to have surgery during the study period.
  • Patients who are unable to comply with the study procedures or follow-up visits.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino Pavia Italy
Centre Hospitalier Regional De La Citadelle Liege Belgium
Mtz Clinical Research Powered By Pratia Warsaw Poland
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Nowa Sol Poland
Centrum Medyczne Oporow Wroclaw Poland
Vita Longa Sp. z o.o. Katowice Poland
Centrum Medyczne Neuromed Sp. z o.o. Bydgoszcz Poland
Hospital Clinico Universitario De Valladolid Valladolid Spain
Halsoklustret AB Stockholm Sweden
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH Bad Homburg Germany
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH Ulm Germany
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Irccs San Raffaele Roma S.r.l. Rome Italy
Hospital General Universitario De Valencia Valencia Spain
Jessa Ziekenhuis Hasselt Belgium
CTC Clinical Trial Consultants AB Uppsala Sweden
Gasthuiszusters Antwerpen Antwerp Belgium
Hospital Ruber Juan Bravo Madrid Spain
Klinische Forschung Berlin GbR Berlin Germany
Akardo AB Stockholm Sweden
Rigshospitalet Copenhagen Denmark
Vrije Universiteit Brussel Jette Belgium
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Synexus Clinical Research GmbH Frankfurt Germany
Centrum Leczenia MIGRE Wroclaw Poland
Clinirem Sp. z o.o. Lublin Poland
Bispebjerg Hospital Copenhagen Denmark
Centermed Krakow Sp. z o.o. Cracow Poland
Kopfschmerzzentrum Frankfurt Frankfurt Germany
Centrum Medyczne Pratia – Katowice Katowice Poland
Dr Sekowska Leczenie Bolu Warsaw Poland
Céphalées et Migraines Neurologie Générale EMG Electromyographie EEG Electroencéphalographie Saint-Nicolas Belgium
Regionshospitalet Viborg Viborg Denmark
Ärztepartnerschaft Dr. med. J. Springub / W. Schwarz Studienzentrum Nord-West Westerstede Westerstede Germany
Hmeidbpi Umcrgqgxavvnm Dr Ld Prmlyyuw Madrid Spain
Huxfpack Ubtwyjbmibfrv Mdfmquy Da Vgqvgtqrpr Santander Spain
Slkacged uhf Pvacnsilcmknvrjv Gvtjkvriao Goeppingen Germany
Sqh Cuxnnh Cnqpmbt e Fgbtbrkgfmmf Ctklzwbg Ain Curnztq Florence Italy
Sazveour Aq Lund Sweden
Hjnqahtv Mntyjjoftw Cqhzyh Lodz Poland
Mwutmplcs Itfomftdte Cqafyqru Ssyuwxap Spx z osxv Warsaw Poland
Mpqf Cupjcqb Mdcwewhp Slvvfkqg Szczecin Poland
Kstigoqt Kmdoeaeutf ao Wcknymcfyt Klagenfurt am Wörthersee Austria
Ucdcofx Uauwqajlov Hxmqrmcs Uppsala Sweden
Ftfrwoszp Pqpl Ln Idnxsvzfxedlp Bftxyicyq Dce Hsynrbzp Uovoxekibxsco Ls Pxv Madrid Spain
Hrahqqeu Vnlu dmursdoq Barcelona Spain
Ifeycbeu Zgotxam Do Bertbxnmlznrwgytt Oświęcim Poland
Squghu Tzechunywpe Om Turku Finland
Plafwci Czsxxv Wvrfkdz skt z okue Wroclaw Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
23.03.2023
Belgium Belgium
Not recruiting
23.03.2023
Denmark Denmark
Not recruiting
23.03.2023
Finland Finland
Not recruiting
23.03.2023
Germany Germany
Not recruiting
23.03.2023
Italy Italy
Not recruiting
23.03.2023
Poland Poland
Not recruiting
23.03.2023
Spain Spain
Not recruiting
23.03.2023
Sweden Sweden
Not recruiting
23.03.2023

Trial locations

Investigated drugs:

Rimegepant is a medication being studied for its ability to prevent migraines in adults who have not had success with other oral preventive treatments. It is being tested to see how well it can reduce the number of migraine days each month.

Investigated diseases:

Migraine – Migraine is a neurological condition characterized by intense, throbbing headaches, often accompanied by nausea, vomiting, and sensitivity to light and sound. These headaches can occur with or without an aura, which are sensory disturbances that can include visual changes or tingling sensations. Migraines typically progress through four stages: prodrome, aura, headache, and postdrome, although not everyone experiences all stages. The frequency and severity of migraines can vary widely among individuals, with some experiencing them occasionally and others having them frequently. The exact cause of migraines is not fully understood, but they are believed to involve genetic and environmental factors. Triggers can include stress, certain foods, hormonal changes, and environmental factors.

Trial ID:
2024-513270-21-00
Protocol code:
C4951012/BHV3000-407
Trial Phase:
Therapeutic confirmatory (Phase III)

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