Rimegepant for Chronic Migraine Prevention
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a daily dose of rimegepant, a medication already used for migraine relief, can prevent chronic migraines. Participants will receive either the active medication or a placebo (a pill with no active ingredient) for 12 weeks, followed by 12 weeks where everyone receives the real medication. The main goal is to determine if rimegepant reduces the number of migraine days each month compared to the placebo. Individuals who have experienced chronic migraines for at least a year, with frequent migraine days, might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new preventive treatment for chronic migraines.
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's best to discuss your specific situation with the study team to understand any potential requirements.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that rimegepant is generally safe for people. In one study, 36% of patients taking rimegepant reported side effects, matching the rate of those taking a placebo (a sugar pill). This indicates that the side effects of rimegepant are similar to those of a sugar pill. Additionally, clinical trials have not linked rimegepant to liver or heart problems.
Other studies also support its safety. Rimegepant, used to treat migraines, has been found safe for up to 52 weeks, even for adults using other migraine medications. The FDA has approved it for treating sudden migraine attacks and preventing occasional migraines, indicating that the treatment has undergone careful safety evaluation under certain conditions. Overall, the evidence suggests rimegepant is a safe choice for preventing migraines.12345Why do researchers think this study treatment might be promising for chronic migraine?
Rimegepant is unique because it offers a new way to prevent chronic migraines with a convenient, orally disintegrating tablet. Unlike many standard treatments that might require injections or have a slower onset, rimegepant works by blocking CGRP receptors, which play a key role in migraine development. This approach not only provides a preventive measure but also allows for acute treatment of breakthrough migraines, making it a versatile option for migraine sufferers. Researchers are excited because this dual-action potential could significantly improve patients' quality of life by reducing both the frequency and severity of migraine attacks.
What evidence suggests that rimegepant might be an effective treatment for chronic migraine?
Research has shown that rimegepant can effectively reduce the number of migraine days each month. In this trial, participants will receive either rimegepant or a placebo. Studies have found that people taking rimegepant experienced a significant decrease in migraines compared to those taking a placebo. For instance, one study reported that monthly migraine days dropped from over 17 to about 3 after three months of using rimegepant. Another study noted a 30% reduction in weekly migraine days within the first week of treatment. These results suggest that rimegepant could be a strong option for preventing chronic migraines.24678
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 aged 18 or older who have had chronic migraines (headaches on at least 15 days per month) for at least one year. Participants must be generally healthy and able to follow study procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Observation
Participants are observed without study intervention to establish baseline migraine frequency
Double-Blind Treatment
Participants receive either rimegepant 75 mg or placebo once daily to evaluate efficacy in reducing migraine days
Open-Label Extension
All participants receive open-label rimegepant 75 mg once daily, with additional doses allowed for breakthrough migraines
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 compares a daily dose of rimegepant (a migraine prevention medicine) with a placebo tablet over 12 weeks, followed by all participants receiving rimegepant for another 12 weeks. The goal is to see if rimegepant reduces the number of migraine days.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive rimegepant 75 mg orally disintegrating tablet (ODT) once daily during the 12-week double-blind treatment phase. Eligible participants may subsequently enter a 12-week open-label extension phase and receive open-label rimegepant 75 mg once daily. During the open-label extension phase, participants may also take an additional dose of rimegepant 75 mg for the acute treatment of breakthrough migraine attacks, up to 10 doses per month.
Participants will receive matching placebo once daily during the 12-week double-blind treatment phase. Eligible participants may subsequently enter a 12-week open-label extension phase and receive open-label rimegepant 75 mg once daily. During the open-label extension phase, participants may also take an additional dose of rimegepant 75 mg for the acute treatment of breakthrough migraine attacks, up to 10 doses per month.
Find a Clinic Near You
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
Evaluating the efficacy of rimegepant as a preventive ...
All five outcome measures improved significantly from baseline to Month 3. Monthly migraine days decreased from 17.27 ± 8.52 to 2.90 ± 2.91, and monthly ...
Rimegepant Achieves Migraine Prevention After 1 Week of ...
Within the first week of treatment, rimegepant-treated participants had a 30% reduction (95% CI, –36.1 to –23.9) in weekly migraine days ...
3.
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. These results ...
Rimegepant: A Review in the Acute Treatment and Preventive ...
Rimegepant was also more effective than placebo at reducing the number of monthly migraine days when taken every other day for the preventive ...
Effectiveness and tolerability of rimegepant in the acute ...
a subjectively reported good/very good effectiveness in 42.7% of cases, a poor effectiveness in 40.0% and no effectiveness in 17.3% of cases ( ...
Oral rimegepant for preventive treatment of migraine
133 (36%) of 370 patients who received rimegepant reported an adverse event, compared with 133 (36%) of 371 who received placebo. Tolerability was similar to ...
Safety Profile | NURTEC® ODT (rimegepant) | For HCPs
Rimegepant 75 mg is safe and well tolerated for the acute treatment of migraine in adults using selective serotonin reuptake inhibitors and other ...
8.
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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