Rimegepant for Migraine Prevention

No longer recruiting at 195 trial locations

Overseen By Pfizer Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Biohaven Pharmaceuticals, Inc.

Disqualifiers: Cluster headaches, Basilar migraine, Chronic pain, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and ease of use of a medication called rimegepant in preventing migraines. It compares rimegepant to a placebo (a pill with no active medication) to determine if it reduces the number of migraines in individuals who haven't found success with other oral migraine preventives. The trial seeks adults who have experienced migraines for over a year, with 4 to 14 migraine days each month, and who haven't responded well to other migraine prevention medications. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits more patients.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it seems that participants with medication overuse headaches are excluded, which might imply some restrictions on current medication use.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should have a history of inadequate response to certain migraine-preventive medications, which might imply some changes to your current treatment. It's best to discuss this with the trial coordinators.

What is the safety track record for Rimegepant?

Research has shown that rimegepant is generally safe for people. Studies have found no signs of liver or heart damage in those taking this medication, which reassures anyone considering it for migraine prevention. Researchers have tested the safety of rimegepant for up to 52 weeks for both treating and preventing migraines, and no serious side effects related to the drug were reported in these studies.

However, it's important to note that the safety of taking more than 18 doses in 30 days remains unknown. Prospective trial participants should keep this in mind. Overall, the data suggests that rimegepant is safe for most people, but discussing any concerns with a healthcare professional is always best. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Rimegepant is unique because it offers a new approach to migraine prevention by targeting the CGRP receptor, unlike traditional treatments like triptans or beta-blockers, which work through different pathways. Most current options, such as triptans, are designed to relieve symptoms after a migraine starts, whereas Rimegepant can be taken preventively to stop migraines from occurring in the first place. Researchers are excited about Rimegepant's potential to provide a more convenient option, as it is taken orally and can be used both for acute treatment and prevention, offering flexibility and potentially reducing the frequency of migraine attacks.

What is the effectiveness track record for rimegepant in migraine prevention?

In this trial, participants will receive either Rimegepant 75 mg or a placebo. Research has shown that rimegepant reduces the number of migraine days for those who suffer from migraines. For example, one study found that people taking rimegepant experienced 4.3 fewer migraine days per month, compared to 3.5 fewer days for those on a placebo, during weeks 9-12. Another study demonstrated that rimegepant was significantly more effective than a placebo in preventing migraines, regardless of their monthly frequency. The medication is considered safe, typically causing few side effects. Overall, rimegepant has successfully treated sudden migraines and prevented them. ^{1 3 5 6 7}

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've had migraines for over a year, with onset before age 50, and experience 4-14 migraine days per month. They must have tried and not responded well to 2-4 types of oral migraine-preventive meds in the past decade. Participants should be able to tell their migraines apart from other headaches.

Inclusion Criteria

My migraines last from 4 to 72 hours without treatment.

I've had 4 to 14 migraine days monthly in the last 3 months.

I can tell the difference between my migraine and other types of headaches.

Exclusion Criteria

Current medication overuse headaches

I've had 15 or more headache days each month for the last 3 months.

I have a history of severe types of headaches or migraines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-blind Treatment

Participants receive rimegepant or placebo every other day for migraine prevention

12 weeks

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Rimegepant

Trial Overview The study tests Rimegepant's effectiveness in preventing migraines compared to a placebo (a substance with no therapeutic effect). It targets those who haven't found relief with standard oral preventive medications. The goal is to see if Rimegepant can reduce the frequency or severity of migraines.

How Is the Trial Designed?

Group I: Rimegepant 75 mg Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Rimegepant is already approved in United States, European Union, Canada, United Kingdom for the following indications:

Approved in United States as Nurtec ODT for:

• Acute treatment of migraine with or without aura in adults
• Preventative treatment of episodic migraine in adults

Approved in European Union as Vydura for:

• Prophylaxis and acute treatment of migraine in adults

Approved in Canada as Nurtec ODT for:

• Acute treatment of migraine with or without aura in adults
• Preventative treatment of episodic migraine in adults

Approved in United Kingdom as Vydura for:

• Prophylaxis and acute treatment of migraine in adults

Who Is Running the Clinical Trial?

Biohaven Pharmaceuticals, Inc.

Lead Sponsor

Trials

49

Recruited

30,100+

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

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]

In a 12-month observational study involving 1862 patients with glaucoma and ocular hypertension, omidenepag isopropyl (OMDI) significantly reduced intraocular pressure (IOP) by an average of -1.9 mmHg, demonstrating its efficacy as both monotherapy and in combination with other treatments.

The overall incidence of adverse reactions (ADRs) was 24.3%, with common side effects including conjunctival hyperemia and refractive disorders, but no serious ADRs like prostaglandin-associated periorbitopathy were reported, indicating a favorable safety profile for OMDI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interim Results of Post-Marketing Observational Study of Omidenepag Isopropyl for Glaucoma and Ocular Hypertension in Japan. Nakazawa, T., Takahashi, K., Kuwayama, Y., et al.[2022]

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]

The study found that once-daily 0.002% omidenepag isopropyl (OMDI) significantly reduced intraocular pressure (IOP) by an average of 2.96 mm Hg in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) who did not respond well to latanoprost, indicating its efficacy as a treatment option.

Safety assessments showed no significant adverse events during the OMDI treatment, suggesting that it is a safe alternative for patients with POAG or OHT who are low or non-responders to existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omidenepag Isopropyl in Latanoprost Low/Non-Responders with Primary Open-Angle Glaucoma or Ocular Hypertension: A Phase 3, Non-Randomized, Two-Phase, Open-Label Study. Panarelli, JF., Bowden, EC., Tepedino, ME., et al.[2023]

Timolol was found to be more effective than Vistagan and Betoptic in lowering eye pressure in patients with primary open-angle glaucoma, but it has a drawback of tachyphylaxis, which reduces its effectiveness over time.

Vistagan and Betoptic are safer alternatives for patients with heart or lung conditions, as they can be used without the contraindications associated with timolol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparative evaluation of the hypotensive effectiveness of beta blockers]. Erichev, VP.[2013]

Omidenepag isopropyl (OMDI) eye drops significantly reduced intraocular pressure (IOP) in patients with normal tension glaucoma (NTG) over a 6-month period, demonstrating their efficacy as a treatment option.

However, the use of OMDI was associated with transient changes in refraction and corneal endothelial cells, an increase in central corneal thickness, and significant corneal erosion, indicating potential safety concerns that need to be monitored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of 0.002% Omidenepag Isopropyl on Intraocular Pressure and the Cornea in Normal Tension Glaucoma. Lee, SH., Lee, WJ., Kim, KW., et al.[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]

In a Phase 3 study involving 26 patients with primary open-angle glaucoma or ocular hypertension who did not respond well to latanoprost, the ophthalmic solution OMDI 0.002% significantly reduced intraocular pressure (IOP) by an average of 2.99 mmHg after 4 weeks of treatment.

OMDI was well tolerated, with no serious adverse events reported, and only mild adverse reactions occurring in 7.7% of patients, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraocular pressure-lowering effect of omidenepag isopropyl in latanoprost non-/low-responder patients with primary open-angle glaucoma or ocular hypertension: the FUJI study. Aihara, M., Ropo, A., Lu, F., et al.[2021]

Rimegepant (NURTEC ODT®) is an orally disintegrating tablet that acts as a highly-selective antagonist of calcitonin gene-related peptide, specifically designed for the acute treatment of migraines.

In February 2020, rimegepant ODT received its first global approval in the USA for treating migraines with or without aura in adults, marking a significant milestone in its development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rimegepant: First Approval. Scott, LJ.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10299922/

Rimegepant: A Review in the Acute Treatment and ... Rimegepant was also significantly more effective than placebo irrespective of migraine attack frequency (≤ 4 or > 4 attacks per month) [32], ...

2. 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.

3. nurtec.com nurtec.com/

Treatment of Migraine | Nurtec® ODT (rimegepant) | Safety Info People taking Nurtec ODT experienced 4.3 fewer MMDs during weeks 9-12 (vs 3.5 fewer MMDs with placebo). help prevent migraine attacks. The safety of using more ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03732638

NCT03732638 | Efficacy and Safety Trial of Rimegepant for ... The purpose of this is study is to compare the efficacy of BHV-3000 (rimegepant) to placebo as a preventive treatment for migraine, as measured by the ...

5. 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. These results ...

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

NURTEC ODT (rimegepant) - accessdata.fda.gov o It is not known if it is safe to take more than 18 doses of NURTEC ODT in 30 days. • For the preventive treatment of episodic migraine, take NURTEC ODT 1 time ...

7. nurtec.pfizerpro.com nurtec.pfizerpro.com/

Nurtec® ODT (rimegepant) | For Healthcare Professionals ^ Safety data. Safety profile studied up to 52 weeks for both acute and preventive migraine treatment. 1. View safety profile. Loading · View safety profile ...