400 Participants NeededMy employer runs this trial

Rimegepant for Chronic Migraine Prevention

Recruiting at 18 trial locations
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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?

PC

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

During the 3 months prior to screening, and ≥1 non-headache day per month
Completion of the Observation Phase and fulfillment of all protocol-defined eligibility requirements prior to randomization
Willing and able to comply with study procedures, including completion of the electronic diary
See 7 more

Exclusion Criteria

I have not recently joined another clinical trial or used investigational drugs.
Any other condition that, in the opinion of the investigator or sponsor, would make study participation unsafe or compromise study conduct
Any medical or psychiatric condition, or clinically significant laboratory abnormality, that in the investigator's judgment may increase risk to the participant or interfere with study participation or interpretation of results, including uncontrolled hypertension or a history of Raynaud's phenomenon
See 7 more

Timeline for a Trial Participant

Observation

Participants are observed without study intervention to establish baseline migraine frequency

4 weeks

Double-Blind Treatment

Participants receive either rimegepant 75 mg or placebo once daily to evaluate efficacy in reducing migraine days

12 weeks
Regular visits for efficacy and safety assessments

Open-Label Extension

All participants receive open-label rimegepant 75 mg once daily, with additional doses allowed for breakthrough migraines

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: Rimegepant 75 mg orally disintegrating tablet (ODT) once dailyExperimental Treatment1 Intervention
Group II: Matching placebo once daily for 12 weeks during the double-blind treatment phasePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

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 ...

Efficacy 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 ...

7.

nurtec.pfizerpro.com

nurtec.pfizerpro.com/safety

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 ...

Rimegepant'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