New nasal spray could ease Kids' migraines
NCT ID NCT06995729
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage study is testing a nasal spray called zavegepant in 16 children aged 6 to 12 who have had migraines for at least 6 months. The main goal is to see if the drug is safe and how the body handles it. Each child gets a single dose based on their weight, and the study lasts up to 10 weeks with 3 clinic visits and 2 phone calls.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- zavegepant (nasal spray)
- What this could lead to
- If this works, it could point toward a fast-acting migraine treatment option for children.
- What could go wrong
- This is a very early Phase 1 trial with only 16 children, so it is primarily checking safety, not whether the drug actually stops migraines. The results may not lead to a proven treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 to 11 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
13 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Accellacare - Piedmont
RECRUITINGStatesville, North Carolina, 28625, United States
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Accellacare US Inc.
RECRUITINGWinston-Salem, North Carolina, 27103, United States
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Accellacare of Piedmont HealthCare
RECRUITINGStatesville, North Carolina, 28625, United States
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Arkansas Children's Hospital
NOT_YET_RECRUITINGLittle Rock, Arkansas, 72202, United States
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Cedar Health Research
RECRUITINGDallas, Texas, 75251, United States
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Central States Research
RECRUITINGTulsa, Oklahoma, 74136, United States
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Children's Hospital & Medical Center
RECRUITINGOmaha, Nebraska, 68114, United States
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Clinical Research Institute
NOT_YET_RECRUITINGMinneapolis, Minnesota, 55402, United States
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Coastal Heritage Clinical Research
RECRUITINGHinesville, Georgia, 31313, United States
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Granger Medical Holladay - Holladay Clinic
RECRUITINGSalt Lake City, Utah, 84117, United States
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True North Neurology
NOT_YET_RECRUITINGPort Jefferson Station, New York, 11776, United States
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Velocity Clinical Research, Washington DC
NOT_YET_RECRUITINGWashington D.C., District of Columbia, 20016, United States
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Wasatch Clinical Research, LLC
RECRUITINGSalt Lake City, Utah, 84107, United States
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