Rimegepant for Menstrual Migraine

Recruiting at 23 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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the efficacy and safety of rimegepant when administered during the peri-menstrual period (PMP) for intermittent prevention of migraine in women who experience menstrual migraine attacks.

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.

What data supports the effectiveness of the drug Rimegepant for treating menstrual migraine?

Rimegepant has been shown to be effective in treating regular migraines by reducing the number of migraine days and improving quality of life, which suggests it might also help with menstrual migraines. ^{1 2 3 4 5}

Is Rimegepant safe for humans?

Rimegepant has been shown to be generally safe for humans, with most side effects being mild or moderate and not causing people to stop using it. It has been well tolerated in studies for treating migraines, and ongoing research is looking at its long-term safety. ^{1 6 7 8 9}

How is the drug Rimegepant unique for treating menstrual migraine?

Rimegepant is unique because it is a calcitonin gene-related peptide (CGRP) receptor antagonist available as an orally disintegrating tablet, which can offer convenience and potentially faster relief compared to traditional tablets. It is also the first drug approved for both the acute treatment and prevention of migraines, making it a versatile option for managing migraine symptoms. ^{1 5 7 8 10}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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, 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Rimegepant Orally Disintegrating Tablet for Acute Migraine Treatment: A Review. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of ubrogepant for the acute treatment of perimenstrual migraine attacks: A post hoc analysis. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of rizatriptan for menstrual migraine in an early intervention model: a prospective subgroup analysis of the rizatriptan TAME (Treat A Migraine Early) studies. [2012]

4. United States 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Rizatriptan efficacy in ICHD-II pure menstrual migraine and menstrually related migraine. [2012]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of Rimegepant, an Oral CGRP Receptor Antagonist, Plus CGRP Monoclonal Antibodies for Migraine. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. Spain pubmed.ncbi.nlm.nih.gov

Rimegepant for the treatment of migraine. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Mapping Migraine-Specific Quality of Life to Health State Utilities in Patients Receiving Rimegepant. [2023]

10. New Zealand pubmed.ncbi.nlm.nih.gov

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