Rimegepant for Migraine

Recruiting at 136 trial locations

Overseen By Pfizer Pfizer CT.gov Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Pfizer

Must not be taking: Triptans, CGRP antagonists

Disqualifiers: Cluster headache, 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

633 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease).

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

The trial does not specify if you need to stop all current medications. However, if you are on a stable dose of prophylactic migraine medication (excluding CGRP antagonists) for at least 3 months, you can continue taking it during the study.

Will I have to stop taking my current medications?

If you are on a stable dose of a preventive migraine medication (except CGRP antagonists) for at least 3 months, you can continue taking it during the study. The protocol does not specify about other medications, so it's best to discuss with the study team.

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

The available research does not provide any data on Rimegepant for Migraine. Instead, it focuses on insulin degludec for diabetes, so there is no information here to support the effectiveness of Rimegepant for treating migraines. ^{1 2 3 4 5}

Is Rimegepant safe for humans?

Rimegepant, used for treating migraines, is generally well tolerated in humans, with no evidence of liver or heart toxicity in clinical trials. Most side effects were mild or moderate and did not lead to stopping the treatment. ^{6 7 8 9 10}

What safety data is available for Rimegepant in treating migraines?

Rimegepant, also known as Nurtec ODT or Vydura, has been evaluated for safety in several clinical trials. It was generally well tolerated, with no evidence of hepatotoxicity or cardiovascular toxicity. Adverse events were mostly mild or moderate and did not lead to trial discontinuation. Long-term safety studies are ongoing, and it has been approved by the FDA for acute migraine treatment. ^{6 7 8 9 10}

Is the drug Rimegepant a promising treatment for migraine?

Yes, Rimegepant is a promising drug for treating migraines. It works quickly to relieve pain and other migraine symptoms and can also help prevent migraines from happening as often. It is easy to take because it dissolves in your mouth, and it has been shown to improve the quality of life for people with migraines. ^{6 7 10 11 12}

How is the drug Rimegepant unique in treating migraines?

Rimegepant is unique because it is the first drug approved for both the acute treatment and prevention of migraines, and it comes in a convenient orally disintegrating tablet form that may work faster than regular tablets. It works by blocking a protein called CGRP, which is involved in migraine attacks, and has been shown to be effective and well-tolerated in clinical trials. ^{6 7 10 11 12}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

Adults who suffer from migraines lasting 4-72 hours, have fewer than 15 headache days a month, and can't use triptan due to intolerance or contraindications like heart disease. They must be able to tell migraines apart from other headaches and have had migraines for over a year before turning 50.

Inclusion Criteria

I've been on a stable dose of migraine prevention medication (not CGRP antagonists) for at least 3 months.

I've had fewer than 15 headache days per month for the last 3 months.

Triptan medications are not suitable for me.

Exclusion Criteria

Current medication overuse headaches

I have a history of specific severe headaches.

I have had headaches on 15 or more days each month for the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-blind Treatment

Participants receive one dose of rimegepant 75 mg or placebo for the acute treatment of migraine

2 hours post-dose

Open-label Extension

Participants receive one dose of rimegepant 75 mg as needed for a qualifying acute migraine

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• Rimegepant

Trial Overview The trial is testing Rimegepant's effectiveness in treating acute migraine attacks compared to a placebo in adults who cannot take triptans. Participants will randomly receive either the medication or placebo to assess relief and tolerability.

Participant Groups

Group I: Rimegepant Experimental Treatment 1 Intervention

Rimegepant - Double-blind (DB) Phase: One dose of rimegepant 75 mg Oral Disintegrating Tablet (ODT) Rimegepant/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT as needed for a qualifying acute migraine. A qualifying migraine is an attack of moderate or severe headache pain intensity. Migraine headache pain intensity will be measured on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe)

Group II: Placebo Placebo Group 2 Interventions

Placebo - Double-blind (DB) Phase: One dose of matching placebo Placebo/Rimegepant - Open-label Extension (OLE) Phase: participants receive one dose rimegepant 75 mg ODT for a qualifying migraine

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?

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

Biohaven Pharmaceuticals, Inc.

Lead Sponsor

Trials

49

Recruited

30,100+

Findings from Research

In a 26-week trial with 458 insulin-naïve patients with type 2 diabetes, insulin degludec (IDeg) significantly improved glycemic control compared to sitagliptin, achieving a greater reduction in HbA1c and fasting plasma glucose levels.

While IDeg was associated with a higher overall rate of confirmed hypoglycemia compared to sitagliptin, the rates of nocturnal hypoglycemia were not significantly different, indicating that IDeg is a safe and effective option for patients needing better blood sugar management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of insulin degludec versus sitagliptin in patients with type 2 diabetes uncontrolled on oral antidiabetic agents. Philis-Tsimikas, A., Del Prato, S., Satman, I., et al.[2022]

In a study involving 20 patients with type 2 diabetes, switching to insulin degludec (IDeg) significantly reduced blood glucose levels before insulin injection in patients using higher doses of basal insulin, indicating its efficacy in better glucose control.

Patients with a shorter duration of diabetes preferred the FlexTouch injection device over conventional insulin devices, suggesting that the new device may enhance user experience and adherence to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Open-label Longitudinal Study on the Efficacy of Switching from Insulin Glargine or Detemir to Degludec in Type 2 Diabetes Mellitus. Kanazawa, I., Notsu, M., Tanaka, K., et al.[2022]

IDegLira, a combination of insulin degludec and liraglutide, showed a greater reduction in HbA1c levels and more significant weight loss compared to both basal-bolus insulin and up-titrated insulin glargine in patients with type 2 diabetes inadequately controlled on basal insulin, based on a pooled analysis of five clinical trials involving 199 to 329 participants.

The use of IDegLira was associated with a lower rate of confirmed hypoglycemia compared to the other insulin strategies, indicating it may provide a safer option for managing blood sugar levels in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy. Freemantle, N., Mamdani, M., Vilsbøll, T., et al.[2022]

The DEVOTE study, involving 7637 patients with type 2 diabetes at high risk for cardiovascular disease, found that degludec is as safe as insulin glargine U100 regarding major adverse cardiovascular events after a median follow-up of 2 years.

Degludec significantly reduced the rates of severe hypoglycemia and nocturnal severe hypoglycemia compared to glargine U100, suggesting it may be a better option for patients at risk for these complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular Outcomes Trials Update: Insights from the DEVOTE Trial. Bilal, A., Pratley, RE.[2019]

Insulin degludec (IDeg) has been shown to be as effective as other basal insulins like insulin glargine and detemir in lowering HbA1c and fasting plasma glucose levels in over 3000 subjects with type 1 and type 2 diabetes across nine clinical trials.

IDeg significantly reduces the incidence of nocturnal hypoglycemia in type 1 diabetes and lowers hypoglycemia rates by 18% compared to insulin glargine and 58% compared to biphasic insulin aspart 30 in type 2 diabetes, highlighting its safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin degludec as an ultralong-acting basal insulin once a day: a systematic review. Wang, F., Surh, J., Kaur, M.[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 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, 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 (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, taken every other day, significantly reduced the mean number of migraine days per month compared to placebo, with a difference of -0.8 days, indicating its efficacy as a preventive treatment for migraines.

The safety profile of rimegepant was comparable to that of placebo, with similar rates of adverse events and no serious safety concerns reported during the study involving 747 participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Croop, R., Lipton, RB., Kudrow, D., et al.[2021]

Rimegepant, an oral medication for treating migraines, was found to be safe and well-tolerated in a phase 1 study involving 16 healthy Chinese participants, with no serious adverse events reported.

The pharmacokinetics of rimegepant showed a median time to maximum concentration of 1.5 hours and minimal accumulation after multiple doses, indicating effective absorption and clearance similar to that observed in non-Asian populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and Safety of Single and Multiple Daily Dosing of 75-mg Rimegepant Orally Disintegrating Tablets in Healthy Chinese Adults: A Randomized Placebo-Controlled Trial. Li, Y., Wang, X., Ballesteros-Perez, A., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of insulin degludec versus sitagliptin in patients with type 2 diabetes uncontrolled on oral antidiabetic agents. [2022]

2. Japan pubmed.ncbi.nlm.nih.gov

An Open-label Longitudinal Study on the Efficacy of Switching from Insulin Glargine or Detemir to Degludec in Type 2 Diabetes Mellitus. [2022]

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

IDegLira Versus Alternative Intensification Strategies in Patients with Type 2 Diabetes Inadequately Controlled on Basal Insulin Therapy. [2022]

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

Cardiovascular Outcomes Trials Update: Insights from the DEVOTE Trial. [2019]

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

Insulin degludec as an ultralong-acting basal insulin once a day: a systematic review. [2021]

6. Spain pubmed.ncbi.nlm.nih.gov

Rimegepant for the treatment of migraine. [2021]

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

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

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

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

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

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

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

Rimegepant: First Approval. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. [2021]

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

Pharmacokinetics and Safety of Single and Multiple Daily Dosing of 75-mg Rimegepant Orally Disintegrating Tablets in Healthy Chinese Adults: A Randomized Placebo-Controlled Trial. [2023]