Rimegepant for Menstrual Migraine

Recruiting at 115 trial locations

Overseen By Pfizer CT.gov Call Center

Age: 18 - 65

Sex: Female

Trial Phase: Phase 3

Sponsor: Pfizer

Disqualifiers: Chronic migraine, Schizophrenia, Bipolar, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

723 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a medicine called rimegepant in preventing menstrual migraines, which are headaches linked to the menstrual cycle. The researchers aim to determine if taking rimegepant at specific times during the menstrual cycle can safely reduce these migraines. Participants will receive either the experimental treatment or a placebo (a pill with no active medicine) to compare effects. Women who have experienced migraines for at least a year and have them during their menstrual cycle may 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 treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on a continuous migraine prevention medication, you must keep the dose stable for at least 3 months before and during the study.

Is there any evidence suggesting that rimegepant is likely to be safe for humans?

Research has shown that rimegepant is generally safe. It is already used to treat sudden migraines and prevent frequent ones, helping both when migraines occur unexpectedly and in reducing their frequency.

One study found that using rimegepant for up to a year was safe for adults, with no serious issues reported. However, the safety of taking more than 18 doses in 30 days remains uncertain, so it is important to adhere to one tablet per day.

Overall, research indicates that rimegepant is safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Rimegepant for menstrual migraines because it offers a new way to tackle these debilitating headaches. Unlike traditional treatments that often involve NSAIDs or triptans, Rimegepant is a CGRP receptor antagonist, which means it blocks a protein involved in migraine development. This unique mechanism can help prevent and treat migraines without the cardiovascular side effects associated with some other medications. Additionally, Rimegepant is available as an orally disintegrating tablet, making it easy to take and fast-acting, which is particularly beneficial during acute migraine attacks.

What evidence suggests that rimegepant might be an effective treatment for menstrual migraine?

Research has shown that rimegepant can reduce the number of migraine days each month. In studies, it performed better than a placebo, a fake pill used for comparison. Participants taking rimegepant reported improved migraine symptoms. It has proven effective and safe for treating migraines, with only a few side effects. This trial tests rimegepant's effectiveness in treating migraines related to the menstrual cycle, with participants receiving either rimegepant or a placebo. ^{6 7 8 9 10}

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 women with a history of menstrual migraines, which are headaches linked to their period. Participants should have experienced these migraines for at least a year and regularly during the last three months. They must have consistent menstrual cycles and if they're on any migraine prevention meds, those doses need to be stable for three months before joining.

Inclusion Criteria

Participant has regular menstrual cycles ≥24 days and ≤34 days

Participant reported history of experiencing at least 1 migraine attack during the perimenstrual period in at least 2 out of 3 menstrual cycles immediately prior to screening

I have had migraines for at least 1 year.

Exclusion Criteria

I have had more than 6 migraine days each month for the last 3 months.

I have chronic migraines or more than 14 headache days a month.

I have a history of specific types of migraines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observation Period

Participants are observed to establish baseline migraine frequency and severity

5 months

Double-Blind Treatment

Participants receive either rimegepant or placebo during the peri-menstrual period for migraine prevention

5 months

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 is testing Rimegepant's effectiveness when taken around the time of menstruation to prevent migraine attacks. Women in the study will either receive Rimegepant, standard care treatments or a placebo without knowing which one they're getting, to compare results fairly.

How Is the Trial Designed?

Group I: Rimegepant 75 mg Orally Disintegrating Tablet (ODT) Acute Treatment Dosing Experimental Treatment 1 Intervention

Group II: Rimegepant 75 mg Orally Disintegrating Tablet (ODT) 7-Day Dosing Experimental Treatment 1 Intervention

Group III: Standard of Care Active Control 1 Intervention

Group IV: Placebo Placebo Group 1 Intervention

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

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

In a study involving 13 patients with migraines, rimegepant was found to be well tolerated when used as an acute treatment alongside CGRP monoclonal antibodies (mAbs) for preventive treatment, with no serious adverse events reported.

Out of the patients, 38% experienced mild to moderate adverse events, primarily nasopharyngitis, indicating that while some side effects occurred, they were generally not severe and did not lead to treatment discontinuation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Rimegepant, an Oral CGRP Receptor Antagonist, Plus CGRP Monoclonal Antibodies for Migraine. Berman, G., Croop, R., Kudrow, D., et al.[2021]

Rimegepant significantly improves outcomes for migraine patients, including freedom from pain and pain relief at 2 hours, with odds ratios indicating strong efficacy compared to placebo.

The treatment shows sustained benefits at 24 hours and does not appear to increase the risk of adverse events, suggesting it is a safe option for migraine management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Rimegepant for Migraine Patients: A Meta-analysis of Randomized Controlled Studies. Yang, C., Zhang, Y.[2023]

Rimegepant is an effective treatment for migraines, showing significant pain relief and reduction in bothersome symptoms compared to placebo in phase III trials, and it can also reduce the number of monthly migraine days when used preventively.

The medication is generally well tolerated, with no signs of liver or heart-related side effects, making it a safe option for adults managing migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rimegepant: A Review in the Acute Treatment and Preventive Treatment of Migraine. Blair, HA.[2023]

Rimegepant, an orally disintegrating tablet approved by the FDA, has been shown in three phase 3 trials to significantly improve pain relief and reduce bothersome migraine symptoms within 2 hours of administration.

This medication offers a new mechanism of action for treating migraines, making it a suitable option for patients who do not respond well to traditional treatments like triptans or who experience adverse effects from them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rimegepant Orally Disintegrating Tablet for Acute Migraine Treatment: A Review. DeFalco, AP., Lazim, R., Cope, NE.[2021]

Rimegepant, an oral CGRP receptor antagonist, has shown significant efficacy in treating migraines, providing pain relief and symptom improvement for up to 48 hours after a single dose, based on completed phase II and III trials.

The medication was well tolerated with only mild to moderate adverse events reported, leading to its FDA approval for acute migraine treatment on February 27, 2020.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rimegepant for the treatment of migraine. Negro, A., Martelletti, P.[2021]

Rimegepant, an oral CGRP receptor antagonist, has shown significant efficacy in reducing monthly migraine days (MMDs) and improving health-related quality of life (HRQoL) compared to placebo, based on a study involving 257 participants with a history of 4-14 MMDs.

When compared to injectable anti-CGRP monoclonal antibodies like galcanezumab and erenumab, rimegepant demonstrated similar effectiveness in reducing MMDs and improving migraine-related disability and quality of life, supporting its use for both acute and preventive migraine treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Matching-adjusted indirect comparisons of oral rimegepant versus placebo, erenumab, and galcanezumab examining monthly migraine days and health-related quality of life in the treatment of migraine. Popoff, E., Johnston, K., Croop, R., et al.[2021]

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06641466

NCT06641466 | A Study to Learn About the ...

Participant reported history of experiencing at least 1 migraine attack during the perimenstrual period in at least 2 out of 3 menstrual cycles immediately ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12595842/

Patient-reported outcomes of rimegepant for acute and ...

We compared TSQM scores at baseline and after treatment and found that both treatment cohorts showed improvements following rimegepant therapy.

3.

headachejournal.onlinelibrary.wiley.com

headachejournal.onlinelibrary.wiley.com/doi/full/10.1111/head.14995

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.

4.

thejournalofheadacheandpain.biomedcentral.com

thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-024-01935-8

Effectiveness and tolerability of rimegepant in the acute ...

Our data confirms rimegepant effectiveness and safety in the acute migraine treatment in a real-world setting in a cohort of participants.

5.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/PFE/pressreleases/35744755/pfizers-promising-phase-3-study-on-menstrual-migraine-prevention-with-rimegepant/

Pfizer's Promising Phase 3 Study on Menstrual Migraine ...

' The study aims to evaluate the efficacy and safety of rimegepant for the intermittent prevention of menstrual migraines in women aged 18 to 45 ...

6.

nurtec.com

nurtec.com/

Treatment of Migraine | Nurtec® ODT (rimegepant) | Safety Info

The safety of using more than 18 doses in a 30-day period has not been established. You should not take more than 1 tablet in 24 hours. Per IQVIA as brand in ...

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accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2021/212728s006lbl.pdf

NURTEC ODT (rimegepant) - accessdata.fda.gov

The safety of using more than 18 doses in a. 30-day period has not been established. 2.2 Recommended Dosing for Preventive Treatment of Episodic Migraine. The ...

8.

mayoclinic.org

mayoclinic.org/drugs-supplements/rimegepant-oral-route/description/drg-20484237

Rimegepant (oral route) - Side effects & dosage

Rimegepant is used to treat acute migraine headaches with or without aura and prevent episodic migraine headaches. Rimegepant is not an ordinary pain reliever.

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11127653/

Safety of Rimegepant in Patients Using Preventive ...

Acute treatment of migraine with rimegepant 75 mg for up to 52 weeks was well tolerated and had a favorable safety profile in adults who were concomitantly ...

10.

nurtec.pfizerpro.com

nurtec.pfizerpro.com/

Nurtec® ODT (rimegepant) | For Healthcare Professionals ^

Safety profile studied up to 52 weeks for both acute and preventive migraine treatment. 1. View safety profile.