Acute Treatment of Migraine study: Zavegepant
Official title A Study to Learn About the Study Medicine Called Zavegepant (PF-07930207) in Children With a History of Migraine
ClinicalTrials.gov ID: NCT06995729
What this study is testing
What is Zavegepant?
This is an investigational nasal spray being studied for the acute treatment of migraine in children. is designed to block CGRP receptors to help stop migraine pain.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether the nasal spray is safe for children with migraines and how the body processes it.
- Who it's for
- You may be able to join if you are a child aged 6 to 11, have had migraines for at least 6 months, and weigh more than 15 kilograms.
- What's involved
- You will receive one spray of the medicine in one nostril. The amount depends on your weight. The study will track how you feel and any side effects.
- Time commitment
- The study lasts up to 10 weeks, with 3 clinic visits and 2 phone follow‑ups.
- Phase 1: an early, usually small safety study
- Time commitment: about 10 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 11
You may be able to join if
- Participants aged 6 years to less than 12 years.
- Documented medical history of migraine with or without aura for at least 6 months before the Screening Visit.
- Weight \>15 kg at the Screening Visit
You likely can't join if
- Evidence or history of clinically significant disease.
- Continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
- Atypical migraine types, complications of a migraine, or a confounding and clinically significant pain syndrome.
- Conditions that may affect the administration or absorption of the nasal product
- 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)
See the full eligibility criteria
- Participants aged 6 years to less than 12 years.
- Documented medical history of migraine with or without aura for at least 6 months before the Screening Visit.
- Weight \>15 kg at the Screening Visit
- Evidence or history of clinically significant disease.
- Continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
- Atypical migraine types, complications of a migraine, or a confounding and clinically significant pain syndrome.
- Conditions that may affect the administration or absorption of the nasal product
- 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)
- Serum Total bilirubin \>1.5 × ULN (Upper Limit of Normal), AST (Aspartate Transferase) or ALT (Alanine Transaminase) \>2 × ULN
- Abnormal ECG (Electrocardiogram) at screening visit
The study team makes the final eligibility decision.
Where it is enrolling
- Washington D.C., District of Columbia, United States
- Hinesville, Georgia, United States
- Minneapolis, Minnesota, United States
- Omaha, Nebraska, United States
- Port Jefferson Station, New York, United States
- Statesville, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Cincinnati, Ohio, United States
- Tulsa, Oklahoma, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 10 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Washington D.C., District of Columbia, United States; Hinesville, Georgia, United States; Minneapolis, Minnesota, United States; Omaha, Nebraska, United States; Port Jefferson Station, New York, United States; Statesville, North Carolina, United States and 4 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.