100 Participants NeededMy employer runs this trial

Rimegepant + Zavegepant for Migraine

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, rimegepant and zavegepant, for relieving acute migraine pain during an Emergency Department visit. Participants will receive either an oral tablet of rimegepant or an intranasal spray of zavegepant and will be monitored for 28 days to assess treatment effectiveness. It is ideal for individuals with migraines severe enough to require emergency care and who have been migraine-free for over 48 hours before their current attack. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive these new treatments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have shown that rimegepant is safe for treating migraines. Participants taking 75 mg doses reported only minor side effects. It proved safe even for those with other health issues like anxiety or heart problems. Research also shows that rimegepant is well-tolerated for up to a year without serious side effects.

For zavegepant, research indicates it is also safe. The nasal spray effectively treats migraines and usually causes only mild side effects. Long-term studies suggest it is safe to use up to eight times a month for a year. Serious side effects were rare, making it a well-tolerated option for migraine relief.

Both treatments have undergone extensive study and are generally safe for treating migraines. However, as research continues, participants should remain aware of potential risks and report any side effects to the study team.12345

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for migraines, such as triptans and NSAIDs, Rimegepant and Zavegepant offer a fresh approach by targeting calcitonin gene-related peptide (CGRP) pathways. Rimegepant is taken as an orally disintegrating tablet, which can be especially convenient during a migraine attack, while Zavegepant is delivered through an intranasal spray, providing rapid relief. Researchers are excited about these treatments because they offer new mechanisms of action and delivery methods, potentially providing faster and more effective relief for migraine sufferers who may not respond well to existing medications.

What evidence suggests that this trial's treatments could be effective for migraine?

Research has shown that rimegepant, which participants in this trial may receive, effectively treats sudden migraine attacks. In clinical trials, 61.3% of patients experienced pain relief two hours after a single dose, and 81.8% felt relief after four hours. This treatment consistently outperformed placebos in several studies.

For zavegepant, another treatment option in this trial, studies have demonstrated its ability to quickly relieve migraine pain. Many patients felt relief within just 15 minutes when using the nasal spray. In comparison trials, zavegepant provided significantly more pain relief than placebos. Both treatments have proven to be safe.678910

Are You a Good Fit for This Trial?

This trial is for people who come to the Emergency Department with a migraine and need acute treatment. Participants must be able to take oral or nasal medication and follow up after their visit. Specific inclusion or exclusion criteria are not detailed.

Inclusion Criteria

English and/or Spanish speaking patients
I am willing to take part in phone check-ins after leaving the hospital.
I went to the ER for a headache that matches migraine symptoms.
See 3 more

Exclusion Criteria

I have not recently used certain strong medications that affect how drugs are processed in my body.
I have used a nasal decongestant within 1 hour before taking the study drug.
I have used pain or headache medicine within an hour of taking the study drug.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day
1 visit (in-person)

Treatment

Participants receive a single dose of rimegepant or zavegepant during an Emergency Department visit for acute migraine treatment

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with post-discharge follow-up through 28 days

4 weeks
Post-discharge follow-up

What Are the Treatments Tested in This Trial?

Interventions

  • Rimegepant
  • Zavegepant

Trial Overview

The study tests two migraine medications, rimegepant (oral) and zavegepant (nasal), given during an Emergency Department visit. Each participant receives one of these drugs, and their response is followed for 28 days. There is no placebo or comparison group.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Zavegepant (Parallel Trial)Experimental Treatment1 Intervention
Group II: Rimegepant (Parallel Trial)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials
433
Recruited
198,000+

Pfizer

Industry 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 profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Tampa General Hospital

Collaborator

Trials
22
Recruited
4,400+

Citations

Rimegepant for the treatment of migraine - PMC - NIH

Rimegepant, a second-generation gepant, has shown efficacy in several clinical trials in treating acute migraine. Ongoing trials are also ...

Efficacy and safety of rimegepant for the acute treatment of ...

This pooled analysis showed rimegepant 75 mg was effective and well tolerated for migraine treatment in Black or African American adult ...

Real-World Open-Label Experience with Rimegepant for the ...

The results of our pilot study demonstrate that rimegepant is generally effective, safe, and well tolerated in treating acute migraine attacks.

Rimegepant Acute Migraine Treatment Reduces Monthly ...

The likelihood of reaching more than a 30% or 50% reduction in MMD from baseline was 5.47 (95% CI: 4.27, 7.00) and 5.74

Is rimegepant an effective treatment for acute migraine pain ...

All three studies found rimegepant to be more effective at eliminating acute migraine pain of moderate to severe intensity compared to the ...

Efficacy and safety of rimegepant for the acute treatment of ...

Results indicated that rimegepant was more effective than placebo, and the 75 mg dose was observed to be more effective than the 25 mg dose. These results are ...

Rimegepant's Safety Profile in Adults with Migraine and ...

They concluded the rimegepant demonstrated favorable safety and tolerability in adults with migraine who had a history of anxiety and depression ...

Efficacy and safety of rimegepant for the acute treatment of ...

This pooled analysis showed rimegepant 75 mg was effective and well tolerated for migraine treatment in Black or African American adult ...

Survey Data Highlights Real-World Use of Rimegepant for ...

Rimegepant is effective for short-term prevention in patients with predictable migraine triggers, offering flexibility and targeted relief. STP ...

Safety and Effectiveness of Rimegepant for Acute ...

Conclusions. In triptan-unsuitable adults, RIM 75 mg ODT PRN for up to 12 weeks demonstrated favorable safety, stable population-level effects ...