Rimegepant for Migraine Prevention

Recruiting at 173 trial locations

Overseen By Pfizer Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Biohaven Pharmaceuticals, Inc.

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study is being conducted to evaluate the efficacy and tolerability of rimegepant for migraine prophylaxis in adults with a history of inadequate response to oral preventive medications

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.

What data supports the idea that the drug Rimegepant for Migraine Prevention is an effective treatment?

The available research shows that Rimegepant is effective in reducing the number of migraine days each month when taken every other day. In studies, it was more effective than a placebo, which is a dummy treatment used for comparison. People who took Rimegepant experienced fewer migraines and reported an improved quality of life over a long period, up to 52 weeks. Additionally, Rimegepant was well tolerated, meaning it didn't cause serious side effects in the trials. ^{1 2 3 4 5}

What safety data is available for Rimegepant in migraine treatment?

Rimegepant, also known as Nurtec ODT or Vydura, has been evaluated in several clinical trials for both acute and preventive treatment of migraines. It has been shown to be generally well tolerated, with no evidence of hepatotoxicity or cardiovascular toxicity. Adverse events reported were mild or moderate and did not lead to trial discontinuation. Long-term safety studies are ongoing to further assess its safety profile. ^{1 2 3 4 5}

Is the drug Rimegepant a promising treatment for preventing migraines?

The information provided does not include any details about Rimegepant or its effectiveness for migraine prevention. Therefore, we cannot determine if it is a promising treatment based on the given data. ^{6 7 8 9 10}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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.

Treatment Details

Interventions

• Placebo (Drug)
• Rimegepant (Calcitonin Gene-Related Peptide (CGRP) Antagonist)

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.

Participant Groups

Group I: Rimegepant 75 mg Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Rimegepant is already approved in Canada for the following indications:

Approved in Canada as Nurtec ODT for:

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

Findings from Research

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 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 (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]

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]

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]

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]

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]

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]

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]

References

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

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

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

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

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

Rimegepant: First Approval. [2022]

4. Spain pubmed.ncbi.nlm.nih.gov

Rimegepant for the treatment of migraine. [2021]

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

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

6. Russia (Federation) pubmed.ncbi.nlm.nih.gov

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

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

Interim Results of Post-Marketing Observational Study of Omidenepag Isopropyl for Glaucoma and Ocular Hypertension in Japan. [2022]

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

Influence of 0.002% Omidenepag Isopropyl on Intraocular Pressure and the Cornea in Normal Tension Glaucoma. [2023]

9. Japan 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. [2021]

10. United States 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. [2023]