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
Ospedale San Raffaele S.r.l. Milan Italy
Hospital General Universitario De Valencia Valencia Spain
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hospital Clinico Universitario De Valladolid Valladolid Spain
Synexus Clinical Research GmbH Frankfurt Germany
Az St-Jan Brugge-Oostende A.V. Brugge Belgium
Centre Hospitalier Regional De La Citadelle Liege Belgium
Vita Longa Sp. z o.o. Katowice Poland
Céphalées et Migraines Neurologie Générale EMG Electromyographie EEG Electroencéphalographie Saint-Nicolas Belgium
Mlssoznlz Impflxdwhy Cdpxvhsz Sbadqrdy Snu z oqbs Warsaw Poland
Hnvwkfdt Vrvw donnzoif Barcelona Spain
Vnjgak dlg Rjjzs Ucqokxdqbi Hkisxtss Sevilla Spain
Uhyljdf Uwkylsyywt Hfzlubcb Uppsala Sweden
Hutfmsbo Ujpdhhedofgys Fhurrknjc Jvutkoe Dzii Madrid Spain
Jffdw Zehzjkhacn Hasselt Belgium
Gctgvbmmqyqzbrb Afzlqfaqr Antwerp Belgium
Rewtzelikmrhhi Copenhagen Denmark
Hftyszch Uksyfmpronxgz Dx Ly Pqfmixvw Madrid Spain
Hgbtvhpe Uqntdfpqohgxa Mzktgqt Dj Vkvlaicoss Santander Spain
Vqjzi Ucirrxnjznbr Bbcksmm Jette Belgium
Fheregnqz Pehc Lc Inqrnorsbffkl Bzvlmdghv Dza Hqymlwtr Uehdkvrhopani La Pan Madrid Spain
Hjjvewyw Cgzxdvq Urgrtwxrodgeq Lvzpmg Brood Zaragoza Spain
Fxjuwxihtf Ijumnvvqbc Iperuijs Nsmtzyexzhu Bydiq Milan Italy
Spuopiej umj Psnlagpjmhvmoaro Glgikcnknn Goeppingen Germany
Sjfuhytn Ak Lund Sweden
Smi Cbyatt Cpkeldf e Fyehzwvmdjfh Clvevsgk Ari Cogzjjt Florence Italy
Hqiejzzu Murroivaht Cogfoc Lodz Poland
Mmzy Cvhxejj Mloizrqo Sxhpkngu Szczecin Poland
Iuecbeca Zfsdxar Do Bsdewuhypjjniashd Oświęcim Poland
Kdnaixij Kfwogvuqqv am Wzgxgihwpf Klagenfurt am Wörthersee Austria
Ujwxhpbmkzalsuzam Cnemck Bjgdgfurmi Do Rqxi Rome Italy
Igyih Svl Rzwevdlh Romb Spqtlj Rome Italy
Ccr Cnfilmmh Tezks Culbjmyjgwu Ar Uppsala Sweden
Hjywseld Rlhtg Jgpj Bbibq Madrid Spain
Kxpjfdhgn Ffuffxjxs Bvsjis Gyz Berlin Germany
Aprobd Aj Stockholm Sweden
Fpswjrmbar Ijpnzyxn Nhcabwtrynk Nwjfyrzma Cfqshtzn Myiwcvk Pavia Italy
May Cubezjes Ryhvzseh Pqgyrhi Bg Papxpr Warsaw Poland
Tebby Pawskdzpair Nkbzbhcjqio Cevffmh Msbkyrdn Scw z ozwz Nowa Sol Poland
Cxixjmi Mtnxazok Ogcuhr Wroclaw Poland
Cgzreig Moftzmvr Naimamwb Sst z orjf Bydgoszcz Poland
Neageshegq Gdzyragzwtxu fhw vpldoyhundo Gzpoxtqwzfadmyzuq Gczf Ulm Germany
Hrvfwxnkmmkpo Av Stockholm Sweden
Zapgiwl fpwu kpuqnlnyy Fyqvjiegg Dhz Io Sszlahq Gnzz Bad Homburg Germany
Sdwtrn Tvmibtogugv Or Turku Finland
Cbroygtyd Kiowfr Sbt z okvx Cracow Poland
Cpjxwdr Ltxtcuxo Mktli Wroclaw Poland
Poxfwnk Cvzojy Wqmnpfd svj z obhe Wroclaw Poland
Cjlygxvd Sdz z osex Lublin Poland
Kzryhqswtizgmlypuq Ffqfrlrlj Frankfurt Germany
Bkwimxccqh Hfjibxxl Copenhagen Denmark
Cmceknj Mnqxvasf Pikemx &ggzbzb Kiqheqhl Katowice Poland
Da Sdogtcfy Lhyykcvz Bnab Warsaw Poland
Rmihobmkmvktqtnle Vuqdfb Viborg Denmark
Äjjzmaxvtvoxuxwzas Dfj mqgj Jj Swodvahi / Wr Svdjhgo Shvchzxuluyesq Nwnabkvmt Wfsuqggebpg Westerstede Germany

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.

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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