Rimegepant for Migraine Prevention
What You Need to Know Before You Apply
What is the purpose of this trial?
This study is being conducted to evaluate the efficacy and tolerability of rimegepant for migraine prophylaxis in adults with a history of inadequate response to oral preventive medications
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, it seems that participants with medication overuse headaches are excluded, which might imply some restrictions on current medication use.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have a history of inadequate response to certain migraine-preventive medications, which might imply some changes to your current treatment. It's best to discuss this with the trial coordinators.
What safety data is available for Rimegepant in migraine treatment?
Rimegepant, also known as Nurtec ODT or Vydura, has been evaluated in several clinical trials for both acute and preventive treatment of migraines. It has been shown to be generally well tolerated, with no evidence of hepatotoxicity or cardiovascular toxicity. Adverse events reported were mild or moderate and did not lead to trial discontinuation. Long-term safety studies are ongoing to further assess its safety profile.12345
Is Rimegepant safe for humans?
Is the drug Rimegepant a promising treatment for preventing migraines?
What makes the drug Rimegepant unique for migraine prevention?
Rimegepant is unique for migraine prevention because it is an oral medication that works by blocking a protein called CGRP (calcitonin gene-related peptide), which is involved in migraine attacks. Unlike some other migraine treatments that require injections, Rimegepant is taken as a dissolvable tablet, making it more convenient for patients.678910
What data supports the idea that the drug Rimegepant for Migraine Prevention is an effective treatment?
The available research shows that Rimegepant is effective in reducing the number of migraine days each month when taken every other day. In studies, it was more effective than a placebo, which is a dummy treatment used for comparison. People who took Rimegepant experienced fewer migraines and reported an improved quality of life over a long period, up to 52 weeks. Additionally, Rimegepant was well tolerated, meaning it didn't cause serious side effects in the trials.12345
What data supports the effectiveness of the drug Rimegepant for migraine prevention?
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
This trial is for adults who've had migraines for over a year, with onset before age 50, and experience 4-14 migraine days per month. They must have tried and not responded well to 2-4 types of oral migraine-preventive meds in the past decade. Participants should be able to tell their migraines apart from other headaches.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Double-blind Treatment
Participants receive rimegepant or placebo every other day for migraine prevention
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- Rimegepant
Rimegepant is already approved in United States, European Union, Canada, United Kingdom for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Biohaven Pharmaceuticals, Inc.
Lead Sponsor
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University