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Rimegepant sulfate is a chemically synthesised substance that belongs to a class of medicines called calcitonin gene-related peptide (CGRP) receptor antagonists.[4] The registry name in the EU Clinical Trials Information System (CTIS) is RIMEGEPANT SULFATE, and it is the active substance under investigation in the trial described on this page.[1] In the United States, rimegepant is known under the brand name Nurtec® ODT, where ODT stands for orally disintegrating tablet, a tablet that dissolves in the mouth.[3] In the United Kingdom, the same substance appears under the trade name Vydura® in the Northampton General Hospital formulary.[5] The substance data from the CTIS product record states that rimegepant sulfate is authorised as a medicine, though the specific authorisation record is not detailed in the registry extract.[1] It is classified under the therapeutic area of nervous system diseases.[1]
Rimegepant sulfate works by blocking the receptor for calcitonin gene-related peptide, a protein that is released during migraine attacks and is involved in pain signalling and inflammation in the brain.[4] By preventing CGRP from binding to its receptor, rimegepant is thought to reduce the processes that trigger and sustain migraine pain. The British National Formulary categorises rimegepant under calcitonin gene-related peptide inhibitors within the central nervous system section.[5] Because this mechanism acts on a specific molecular target rather than broadly suppressing nerve activity, rimegepant is described as a targeted preventive treatment for migraine.
Rimegepant sulfate is given by mouth. In the registered Phase 3 trial for adolescents with chronic migraine, the dose under investigation is 75 mg taken orally.[1] The pharmaceutical form described in the CTIS record is for oral use.[1] In the US, rimegepant is available as an orally disintegrating tablet that dissolves in the mouth without water.[3] The Phase 4 study in episodic migraine is testing two dosing schedules: a 75 mg tablet taken daily, and a regimen that alternates between a 75 mg tablet and a placebo every other day.[3] The product information for the authorised medicine gives a 75 mg oral dose, as reported in the sources; the exact schedule depends on whether it is used for acute treatment or prevention.[3]
The registered CTIS trial is a Phase 3 interventional study that is currently authorised, meaning it has received regulatory approval to start or continue.[1] It is a randomised, double-blind, placebo-controlled study with an open-label extension, designed to investigate rimegepant for the prevention of chronic migraine in adolescents aged 12 to under 18 years.[1] The trial plans to enrol 200 participants.[1] The primary outcome measure is the mean change from the observation phase in the number of migraine days per month over the entire 12-week double-blind treatment phase.[1] Participants are randomly assigned to receive either rimegepant 75 mg by mouth or a matching placebo.[1] Because the study is double-blind, neither the participants nor the researchers know who is receiving which treatment until the study is complete.[1] The open-label extension means that after the double-blind phase, participants may receive rimegepant without blinding.[1]
In addition to this registered trial, published results from a Phase 3 randomised controlled trial in adults with migraine provide evidence on the preventive effect of rimegepant. That study, which included 695 participants, found that people taking rimegepant 75 mg every other day had a statistically significant reduction of 4.5 migraine days per month from baseline, compared with a 3.7 day reduction in the placebo group (p=0.0176).[4] A separate Phase 4 study is currently evaluating whether rimegepant works as well when taken daily as when taken every other day for episodic migraine prevention in adults.[3] A real-world observational study is also collecting survey data from adults in the United States who have been treated with rimegepant, focusing on migraine-specific quality of life and treatment experience.[2]
The supplementary sources provided for this page do not contain a dedicated list of side effects for rimegepant sulfate. The Phase 4 study summary states that the study is evaluating whether the drug is well tolerated and safe, but does not report specific adverse events.[3] The Phase 3 published results mention the primary endpoint but do not describe side effect data.[4] Because no source in the provided material lists common or serious side effects, this section cannot be completed from the available data.
What condition is the registered rimegepant trial studying?
The registered trial is studying chronic migraine in adolescents aged 12 to under 18 years. Chronic migraine means having migraine headaches on many days each month. The trial tests whether rimegepant 75 mg taken by mouth can prevent these migraine days better than a placebo.[1]
Who can take part in the registered trial?
The trial enrols adolescents aged 12 to under 18 years who have chronic migraine. It is a Phase 3 study, which means it is being tested in a larger group of patients after earlier studies suggested the medicine may work. The trial is currently authorised, so recruitment can proceed according to the approved protocol.[1]
What is the main thing the trial is measuring?
The primary outcome is the mean change in the number of migraine days per month, measured from the observation phase through the entire 12-week double-blind treatment period. A migraine day is a day on which a participant has a migraine headache.[1]
Is rimegepant already used as a medicine?
Yes. Rimegepant is approved in the United States for the acute treatment of migraine in adults and for the preventive treatment of episodic migraine in adults. In the UK, it appears in the Northampton General Hospital formulary under the brand name Vydura®, with NICE technology appraisals covering both prevention and treatment of migraine.[3][5]
What evidence exists for rimegepant in migraine prevention?
A published Phase 3 trial in 695 adults with migraine found that rimegepant 75 mg taken every other day reduced monthly migraine days by 4.5 days from baseline, compared with 3.7 days for placebo. The difference was statistically significant (p=0.0176).[4]
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