Rimegepant for Migraine
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a second dose of rimegepant, a migraine medication, can relieve pain when the first dose is insufficient. It seeks to determine if taking an additional dose is safe and manageable for those needing extra relief during a migraine attack. Eligible participants should have experienced migraines for at least a year and have 6-14 migraine days per month. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand how it can benefit more patients.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It seems you can continue using your current acute migraine treatments as long as they follow local guidelines.
What is the safety track record for rimegepant?
Previous studies have shown that rimegepant is safe for people with migraines. Research indicates that it is well tolerated, even by those with moderate to high heart-related risk factors. One study found that very few people stopped taking rimegepant due to side effects, and it did not cause liver problems. Over a year, adults safely and effectively managed migraine attacks with rimegepant. Even at higher doses, it did not lead to significant negative effects. Overall, these findings suggest that rimegepant is generally well tolerated for treating migraines.12345
Why are researchers enthusiastic about this study treatment?
Rimegepant is unique because it offers a fast-acting, oral disintegrating tablet (ODT) for treating acute migraine attacks. Unlike standard migraine treatments like triptans, which constrict blood vessels, rimegepant works by blocking the CGRP receptor, a key player in migraine development. This new mechanism of action not only provides rapid relief but also reduces the likelihood of cardiovascular side effects, making it a promising option for individuals who cannot tolerate triptans. Researchers are especially enthusiastic about its potential to deliver quick results and its convenient dosing, which can be repeated if needed within the same day.
What is the effectiveness track record for rimegepant in treating migraines?
Research has shown that rimegepant effectively treats migraines. In studies, 37.6% of participants reported relief from their most bothersome symptom just two hours after taking rimegepant. Trials involving over 4,800 patients demonstrated that it provided better pain relief than a placebo, with fewer participants needing additional medication. Those taking rimegepant also reported greater satisfaction with their treatment. Overall, rimegepant reduces migraine symptoms and enhances the quality of life for many users.678910
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 have migraines and may need a second dose of rimegepant if their migraine returns after the first dose. Participants should generally be in good health, but specific inclusion or exclusion details are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive rimegepant 75 mg ODT for the acute treatment of migraine attacks, with the option to take a second dose within 24 hours if needed
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 is testing how safe it is to take an extra (second) dose of rimegepant during a single migraine attack if needed. The focus is on safety and tolerability when redosing.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive rimegepant 75 mg ODT to administer for the acute treatment of migraine attacks of moderate or severe headache pain intensity. A second rimegepant 75 mg ODT should be taken in the event that participants are not pain free at approximately 2 hours post initial dose OR upon headache relapse after initial pain freedom. The second dose should be taken within 24 hours of the initial dose. Participants will receive rimegepant over a 24 week period during the OLT phase. Participants may redose with rimegepant up to a maximum of 10 times per month (28 days) during the OLT phase.
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Who Is Running the Clinical Trial?
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
Citations
Effectiveness and tolerability of rimegepant in the acute ... - PMC
Patient' reported outcomes (PROs). Regarding rimegepant intake, participants reported a global satisfaction of 7.1 [6.6 – 7.6] on a 0–10 scale.
Rimegepant, an Oral Calcitonin Gene–Related Peptide ...
The percentage of patients who were free from their most bothersome symptom 2 hours after the dose was 37.6% in the rimegepant group and 25.2% ...
3.
neurologylive.com
neurologylive.com/view/pooled-analysis-demonstrate-rimegepant-effectiveness-acute-migraine-treatmentPooled Analysis Demonstrate Rimegepant's Effectiveness ...
Across 4 trials with over 4800 patients, rimegepant demonstrated superior pain and symptom relief 2 hours post-dose, with fewer requiring rescue medication.
4.
headachejournal.onlinelibrary.wiley.com
headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.14994Efficacy and safety of rimegepant for the acute treatment of ...
Results indicated that rimegepant was more effective than placebo, and the 75 mg dose was observed to be more effective than the 25 mg dose.
5.
digitalcommons.pcom.edu
digitalcommons.pcom.edu/cgi/viewcontent.cgi?article=1622&context=pa_systematic_reviewsIs rimegepant an effective treatment for acute migraine pain in ...
RESULTS: All RCT's found rimegepant to be superior in eliminating migraine pain compared ... Results of this study indicate rimegepant 75 mg was ...
Safety of Rimegepant in Adults with Migraine and ... - PMC
Rimegepant showed favorable safety and tolerability in adults with migraine and CV risk factors, including those with moderate to high CV risk.
7.
headachejournal.onlinelibrary.wiley.com
headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.14995Efficacy and safety of rimegepant for the preventive treatment ...
Rimegepant was well tolerated, with a very low rate of AEs leading to study drug discontinuation and no evidence of drug-induced liver injury.
8.
neurologylive.com
neurologylive.com/view/survey-data-highlights-real-world-use-rimegepant-short-term-migraine-preventionSurvey Data Highlights Real-World Use of Rimegepant for ...
A recent survey reveals rimegepant's effectiveness for short-term migraine prevention, highlighting user demographics, triggers, and treatment strategies.
Safety of Rimegepant in Patients Using Migraine Medications
Acute treatment of migraine with rimegepant 75 mg for up to 52 weeks was well tolerated and had a favorable safety profile in adults
NCT03732638 | Efficacy and Safety Trial of Rimegepant for ...
A 52-week open-label extension study to evaluate the safety and efficacy of oral rimegepant for the preventive treatment of migraine.
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