Rimegepant for Migraine
(RIM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a medication called Rimegepant to evaluate its effectiveness for people with migraines. Researchers aim to determine if this treatment can help those whose migraines are triggered by activities such as exercise, alcohol, or stress. Suitable participants will have experienced migraines for at least a year, with 2-8 migraine attacks per month triggered by specific activities. Participants should distinguish their migraine attacks from other headache types and have migraines triggered by these activities most of the time. As a Phase 4 trial, this research focuses on understanding how this already FDA-approved and effective treatment can benefit more patients.
Will I have to stop taking my current medications?
If you're on a stable treatment plan for migraines, you should continue it during the study. However, if you're using certain migraine medications like gepants or narcotics regularly, you may not be eligible to participate.
What is the safety track record for Rimegepant?
Research has shown that Rimegepant, the treatment under study, is safe. In earlier studies, participants who took Rimegepant 75 mg for up to a year found it safe and easy to handle. No serious liver problems were reported, indicating a positive safety profile. These studies also demonstrated that participants continued to benefit from the treatment, which was generally easy to manage. Even those with conditions like anxiety or depression tolerated the treatment well. Overall, Rimegepant appears to be a safe option for treating migraines.12345
Why are researchers enthusiastic about this study treatment?
Rimegepant is unique because it offers a new approach to treating migraines by targeting and blocking a specific protein called CGRP (calcitonin gene-related peptide), which is involved in pain transmission. Unlike traditional migraine treatments like triptans, which constrict blood vessels, Rimegepant works without causing such side effects, making it suitable for people who cannot use triptans. Researchers are excited about Rimegepant because it can be taken as a quick-dissolving tablet, providing fast relief and convenience compared to some other options that may require injections or more complex dosing schedules.
What is the effectiveness track record for Rimegepant in treating migraines?
Research has shown that rimegepant effectively treats migraines. In several studies, participants taking rimegepant 75 mg experienced fewer migraine days each month compared to those taking a placebo (a pill with no active medicine). Another study found that rimegepant helped more people become pain-free and relieved other migraine symptoms. It works well and causes few side effects. Over a year, patients consistently reported relief and satisfaction with rimegepant, with no signs of headaches from overuse. Overall, rimegepant is a reliable option for managing migraines.678910
Who Is on the Research Team?
Jessica Ailani, MD
Principal Investigator
MedStar's Georgetown University Hospital
Are You a Good Fit for This Trial?
This trial is for adults over 18 in the US with a history of migraines triggered by specific activities like exercise, moderate alcohol consumption, air travel up to 12 hours, sexual activity, fasting up to 24 hours, or stress. Participants should have had migraines for at least a year and experience them frequently enough to distinguish from other headaches.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive preemptive treatment with Rimegepant for predictable trigger-induced migraine
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Rimegepant
Trial Overview
The study tests Rimegepant 75 MG as a preemptive treatment for migraines induced by predictable triggers. It's an open-label trial where all participants know they're receiving the medication and are monitored at Medstar Georgetown Headache Center.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Medstar Health Research Institute
Lead Sponsor
Pfizer
Industry 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
Citations
Efficacy and safety of rimegepant for the acute treatment ...
Rimegepant 75 mg demonstrated efficacy superior to placebo for the acute treatment of migraine, with a favorable safety profile, in participants in Japan.
2.
headachejournal.onlinelibrary.wiley.com
headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.14995Efficacy and safety of rimegepant for the preventive treatment ...
Results showed that rimegepant was more effective than placebo in reducing monthly migraine days, with very few adverse effects.
3.
neurologylive.com
neurologylive.com/view/effectiveness-rimegepant-further-displayed-pooled-phase-3-analysisEffectiveness of Rimegepant Further Displayed in Pooled ...
Results showed that treatment with rimegepant 75 mg once daily outperformed placebo on the co-primary end points of pain freedom and freedom ...
Gepants for Migraine: An Update on Long-Term Outcomes ...
Rimegepant demonstrates sustained efficacy and minimal adverse events over 52 weeks, with no evidence of medication-overuse headaches or ...
Treatment Outcomes in People with Migraine Receiving ...
Patients prescribed rimegepant monotherapy reported high satisfaction, response consistency, and treatment optimization. These data provide real-world evidence ...
A multicenter, open-label long-term safety study of ...
Conclusions: Rimegepant 75 mg up to once per day as EOD + PRN for 12 weeks or PRN for up to 52 weeks was safe and well tolerated. No signal of hepatotoxicity, ...
7.
headachejournal.onlinelibrary.wiley.com
headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.15002A 52‐week open‐label extension study to evaluate the safety ...
The OLE data showed favorable tolerability and sustained and increasing treatment benefits with rimegepant 75 mg (EOD and as-needed dosing) over ...
8.
dovepress.com
dovepress.com/safety-of-rimegepant-in-patients-using-preventive-migraine-medications-peer-reviewed-fulltext-article-JPRSafety of Rimegepant in Patients Using Migraine Medications
Conclusion: Acute treatment of migraine with rimegepant 75 mg for up to 52 weeks was well tolerated and had a favorable safety profile in adults ...
NURTEC® ODT (rimegepant) | For HCPs | Risk Info
Safety data. Safety profile studied up to 52 weeks for both acute and preventive migraine treatment. 1. View safety profile. Loading · View safety profile ...
10.
physiciansweekly.com
physiciansweekly.com/post/rimegepants-safety-profile-in-adults-with-migraine-and-mental-health-conditionsRimegepant's Safety Profile in Adults with Migraine and ...
They concluded the rimegepant demonstrated favorable safety and tolerability in adults with migraine who had a history of anxiety and depression ...
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