Zavegepant (nasal spray) for treating migraine in children 6 to under 12
A PHASE 1, MULTICENTER, OPEN-LABEL, SINGLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF ZAVEGEPANT IN CHILDREN 6 TO LESS THAN 12 YEARS OF AGE WITH HISTORY OF MIGRAINE
This trial will test a single weight-based dose of zavegepant nasal spray to see how safe it is and how the medicine is processed in children 6 to under 12 with migraine.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 6 Years to 11 Years |
| Sex | All |
| Sponsor | Pfizer Industry-sponsored |
| Locations | 13 sites (Little Rock, Arkansas and 12 other locations) |
| Trial ID | NCT06995729 on ClinicalTrials.gov |
What this trial studies
This phase 1, open-label trial gives a single intranasal dose of zavegepant to children with a history of migraine and measures blood levels over time and any side effects. Dosing is determined by the child’s weight, and participants will be followed for safety and pharmacokinetic sampling. The study includes three clinic visits over about 10 weeks to collect safety data and samples to understand how the drug is absorbed, distributed, metabolized, and cleared. Children with recent continuous migraine, significant medical or uncontrolled psychiatric conditions, certain liver test abnormalities, or issues affecting nasal drug delivery are excluded.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to less than 12 years who weigh more than 15 kg, have had migraine for at least six months, and have no significant medical, hepatic, psychiatric, or nasal-condition exclusions.
Not a fit: Children with continuous or atypical migraines, uncontrolled psychiatric conditions, certain liver test abnormalities, nasal conditions that affect spray delivery, or who weigh 15 kg or less are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could identify safe, weight-appropriate dosing and safety information that would support use of zavegepant nasal spray for acute migraine in children.
How similar studies have performed: Adult trials of intranasal zavegepant and oral gepants have shown efficacy and acceptable safety, and this pediatric study builds on that prior adult experience.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participants aged 6 years to less than 12 years. 2. Documented medical history of migraine with or without aura for at least 6 months before the Screening Visit. 3. Weight \>15 kg at the Screening Visit Exclusion Criteria: 1. Evidence or history of clinically significant disease. 2. Continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit. 3. Atypical migraine types, complications of a migraine, or a confounding and clinically significant pain syndrome. 4. Conditions that may affect the administration or absorption of the nasal product 5. Any psychiatric condition that is uncontrolled and/or untreated, including: * Clinically significant depression (Promis Parent Proxy SF 2.0 Depressive Scale T score ≥70) * Suicidal ideation and behaviour (C-SSRS: any "yes" to items 2 to 5 or any "yes" to suicide behaviours) 6. Serum Total bilirubin \>1.5 × ULN (Upper Limit of Normal), AST (Aspartate Transferase) or ALT (Alanine Transaminase) \>2 × ULN 7. Abnormal ECG (Electrocardiogram) at screening visit
Where this trial is running
Little Rock, Arkansas and 12 other locations
- Arkansas Children's Hospital — Little Rock, Arkansas, United States (Not_yet_recruiting)
- Velocity Clinical Research, Washington DC — Washington D.C., District of Columbia, United States (Not_yet_recruiting)
- Coastal Heritage Clinical Research — Hinesville, Georgia, United States (Recruiting)
- Clinical Research Institute — Minneapolis, Minnesota, United States (Not_yet_recruiting)
- Children's Hospital & Medical Center — Omaha, Nebraska, United States (Recruiting)
- True North Neurology — Port Jefferson Station, New York, United States (Not_yet_recruiting)
- Accellacare - Piedmont — Statesville, North Carolina, United States (Recruiting)
- Accellacare of Piedmont HealthCare — Statesville, North Carolina, United States (Recruiting)
- Accellacare US Inc. — Winston-Salem, North Carolina, United States (Recruiting)
- Central States Research — Tulsa, Oklahoma, United States (Recruiting)
- Cedar Health Research — Dallas, Texas, United States (Recruiting)
- Wasatch Clinical Research, LLC — Salt Lake City, Utah, United States (Recruiting)
- Granger Medical Holladay - Holladay Clinic — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Pfizer CT.gov Call Center
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
- Phone: 1-800-718-1021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.