Rimegepant for Migraine

Recruiting at 109 trial locations

Overseen By Pfizer CT.gov Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Pfizer

Must not be taking: Multiple migraine preventives

Disqualifiers: Unrelenting headache, Psychiatric condition, 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

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

Compensation: Varies

Number of Visits: 19

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medicine called rimegepant, a migraine treatment, to determine its effectiveness for teens with frequent migraines. Participants will receive either the actual medicine or a placebo to assess rimegepant's efficacy and safety. The trial targets individuals with at least 15 headache days per month, including 8 or more migraines lasting 4 to 72 hours without treatment. Participants will take the medicine every other day, maintain a migraine diary, and visit the clinic regularly. The goal is to evaluate rimegepant's effectiveness and safety for long-term use. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to the potential availability of a new migraine treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use more than one medication for migraine prevention.

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

Research shows that rimegepant, the treatment being studied in this trial, is generally safe and well-tolerated. In earlier studies, adults used rimegepant to treat and prevent migraines without reporting major safety issues. Participants took the medicine up to once a day for as long as 52 weeks, and serious side effects, such as liver problems, were uncommon. However, the safety of using more than 18 doses in a 30-day period remains unconfirmed. This trial aims to better understand the safety of rimegepant for teenagers with frequent migraines. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for migraine?

Rimegepant is unique because it offers a novel approach to treating migraines by targeting the CGRP receptor, which plays a significant role in migraine attacks. Unlike traditional treatments like triptans, which constrict blood vessels, Rimegepant works by blocking the protein known as calcitonin gene-related peptide (CGRP), potentially offering relief with fewer cardiovascular side effects. Researchers are excited about Rimegepant because it can be taken as an oral tablet, providing a convenient alternative to some injectable treatments, and it has shown promise in providing rapid relief from migraines.

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

Research has shown that rimegepant, which participants in this trial may receive, effectively treats migraines. In one study, a single 75 mg dose provided more pain relief than a placebo (a pill with no active medicine). Specifically, 21.2% of patients were free from migraines two hours after taking rimegepant, compared to 10.9% of those on placebo. Additionally, 50% of participants experienced significant pain relief within two hours. Most doctors and patients express satisfaction with rimegepant as a treatment option. Overall, these results suggest rimegepant can effectively reduce migraine symptoms. ^{4 6 7 8 9}

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 adolescents with frequent migraines, specifically those who have had a history of migraine for at least 6 months, experience headaches on 15 or more days per month, and suffer from migraines on at least 8 of those days. Each migraine should last between 4 to 72 hours if untreated.

Inclusion Criteria

I have had migraines for at least 6 months.

I experience 15 or more headache days each month.

I experience 8 or more migraine days each month.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Phase 1

Participants receive either rimegepant or placebo every other day to assess safety and efficacy

12 weeks

Up to 6 visits (in-person), home health visits may occur

Treatment Phase 2

All participants receive rimegepant every other day to assess long-term safety

1 year

Up to 13 visits (in-person), home health visits may occur

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 tests Rimegepant, a dissolvable tablet for treating frequent migraines in adolescents. Participants will be randomly divided into two groups: one receiving Rimegepant and the other a placebo every other day for three months. In the second phase lasting one year, all participants receive Rimegepant.

How Is the Trial Designed?

Group I: Rimegepant Experimental Treatment 1 Intervention

Experimental medicine under study

Group II: Placebo Placebo Group 1 Intervention

A placebo does not have any medicine in it but looks just like the medicine being studied.

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

Published Research Related to This Trial

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, 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 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, 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]

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 (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 ... A single 75 mg dose of rimegepant ODT provided superior efficacy to placebo for the acute treatment of migraine [25]. At 2 h post-dose, a ...

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. neurology.org neurology.org/doi/10.1212/WNL.0000000000210468

Treatment Outcomes in People with Migraine Receiving ... For rimegepant, 95% of physicians and 97% of patients were satisfied with current acute treatment. For triptans, 87% of physicians and 78% of ...

4. nurtec.pfizerpro.com nurtec.pfizerpro.com/

Nurtec® ODT (rimegepant) | For Healthcare Professionals ^ For acute treatment at 2 hours, 21.2% of patients on Nurtec ODT (n=142/669) achieved migraine pain freedom vs 10.9% on placebo (n=74/682) (Δ10.3%*; P<0.001), ...

5. practicalneurology.com practicalneurology.com/news/study-compares-nurtec-odt-vs-14-other-treatments-for-acute-migraine/2475275/

Study Compares Nurtec ODT vs 14 Other Treatments for Acute ... 50.0% of participants treated with Nurtec ODT achieved ≥50% pain freedom within 2 hours, which was higher than or similar to other medications ...

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.

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

NURTEC ODT (rimegepant) - accessdata.fda.gov The safety of NURTEC ODT for the acute treatment of migraine in adults has been evaluated in a randomized, double-blind, placebo-controlled trial (Study 1) in ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38659334/

A multicenter, open-label long-term safety study of ... Conclusions: Rimegepant 75 mg up to once per day as EOD + PRN for 12 weeks or PRN for up to 52 weeks was safe and well tolerated. No signal of hepatotoxicity, ...

9. neurologyadvisor.com neurologyadvisor.com/features/nurtec-for-migraines/

Nurtec ODT for Patients With Migraines: Side Effects, Drug ... Nurtec is approved for the acute treatment of migraine attacks with or without aura as well as for the preventative treatment of episodic migraines.