Zavegepant for Migraine

Recruiting at 8 trial locations

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Disqualifiers: Significant disease, Continuous migraine, Psychiatric conditions, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the body processes a new migraine treatment, zavegepant, in children. Researchers seek to learn about the safety and potential effects of this nasal spray medicine. They are recruiting children who have experienced migraines for at least 6 months and weigh over 15 kilograms. Participants will receive a single dose of the medicine, and their experiences will help determine its benefits and any unwanted effects. The trial includes 3 clinic visits and 2 follow-up phone calls over approximately 10 weeks. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

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

Research has shown that zavegepant is generally safe and well-tolerated for adults with migraines. Studies have found it effective in treating migraine attacks and that it has a good safety record compared to some other treatments. However, while it is known to be safe for adults, researchers have not yet determined if zavegepant is safe and effective for children. This study aims to learn more about how children handle and respond to the medicine. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Zavegepant is unique because it offers a new approach to treating migraines by targeting the CGRP (calcitonin gene-related peptide) pathway. Unlike current treatments like triptans, which primarily focus on serotonin receptors, Zavegepant directly blocks CGRP, a protein known to play a crucial role in migraine attacks. This new mechanism of action could potentially provide relief for patients who do not respond well to existing medications, offering a promising alternative for those seeking more effective migraine management. Researchers are particularly excited about the potential for faster relief and fewer side effects compared to traditional options.

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

Research shows that zavegepant nasal spray effectively treats migraines. Studies have found that it quickly reduces pain and other symptoms. In this trial, participants will receive a 10 mg dose of zavegepant, which has provided fast relief and is as safe as taking pills. This treatment has proven effective and well-tolerated in adults, and it is expected to help children too, although more research is needed to confirm this. Overall, the evidence supports zavegepant as a promising option for quick migraine relief. ^{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 children aged 6 to less than 12 years with a history of migraines for at least six months and weighing over 15 kilograms. It aims to understand how Zavegepant, given as a nasal spray, is processed by their bodies.

Inclusion Criteria

I am between 6 and 11 years old.

I weigh more than 15 kg.

I have had migraines for at least 6 months.

Exclusion Criteria

I have had constant migraines for the last month.

I have unusual migraine types or another significant pain condition.

Any psychiatric condition that is uncontrolled and/or untreated, including clinically significant depression (Promis Parent Proxy SF 2.0 Depressive Scale T score ≥70) and suicidal ideation and behaviour (C-SSRS: any 'yes' to items 2 to 5 or any 'yes' to suicide behaviours)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive a single dose of zavegepant as a nasal spray

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 follow-up phone calls

What Are the Treatments Tested in This Trial?

Interventions

• Zavegepant

Trial Overview The study tests the safety and body's handling of Zavegepant (PF-07930207) in young migraine sufferers. Each child receives one dose via nasal spray, with the amount based on weight. Over up to 10 weeks, they'll visit the clinic three times and have two phone calls.

How Is the Trial Designed?

Group I: Zavegepant Experimental Treatment 1 Intervention

Experimental medicine under study

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

Citations

1. neurology.org neurology.org/doi/10.1212/WNL.0000000000204345

Efficacy and Safety of Zavegepant for the Acute Treatment ... Zavegepant 10 mg was effective and well tolerated compared with placebo for the acute treatment of migraine in women.

2. zavzpret.pfizerpro.com zavzpret.pfizerpro.com/about/efficacy

Efficacy Info & Study Results Efficacy and safety of zavegepant nasal spray for the acute treatment of migraine: results of phase 3 double-blind, randomized, placebo controlled trial.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10615551/

Zavegepant nasal spray for the acute treatment of migraine This meta-analysis confirms the effectiveness of Zavegepant nasal spray in treating acute migraine, with significant improvements in pain and symptom relief.

4. jmcp.org jmcp.org/doi/10.18553/jmcp.2025.31.6.598

Clinical evaluation of zavegepant for the acute treatment ... Zavegepant 10 mg showed the smallest treatment effect compared with placebo of all included treatments. REAL-WORLD EFFECTIVENESS. Zavegepant ...

5. thejournalofheadacheandpain.biomedcentral.com thejournalofheadacheandpain.biomedcentral.com/articles/10.1186/s10194-025-01984-7

The efficacy and safety of zavegepant nasal inhalation versus ... Zavegepant 10 mg can quickly relieve symptoms and has no significant difference in safety compared with oral drugs, which can provide rapid and safe efficacy.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2023/216386s000lbl.pdf

ZAVZPRET (zavegepant) nasal spray - accessdata.fda.gov The safety of treating more than 8 migraines in a 30-day period has not been established. 3 DOSAGE FORMS AND STRENGTHS. Nasal spray: 10 mg of zavegepant per ...

7. zavzpret.com zavzpret.com/

ZAVZPRET™ (zavegepant) Migraine Medication | Safety Info ZAVZPRET is not used to prevent migraine attacks. It is not known if ZAVZPRET is safe and effective in children.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10428082/

Safety and Efficacy of Zavegepant in Treating Migraine Zavegepant is an efficacious and well-tolerated abortive treatment modality for episodic migraine in adult patients.

9. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/abs/10.1111/head.14954

Long‐term safety and tolerability of zavegepant 10‐mg nasal ... The findings showed that zavegepant is generally safe and well-tolerated when used either by itself or with medicines that prevent migraine ...