Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New nasal spray could ease Kids' migraines

NCT ID NCT06995729

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 16 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

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

6 to 11 years

Sex

Anyone

Healthy volunteers

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

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Acute treatment of migraine are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Accellacare - Piedmont

    RECRUITING

    Statesville, North Carolina, 28625, United States

  • Accellacare US Inc.

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • Accellacare of Piedmont HealthCare

    RECRUITING

    Statesville, North Carolina, 28625, United States

  • Arkansas Children's Hospital

    NOT_YET_RECRUITING

    Little Rock, Arkansas, 72202, United States

  • Cedar Health Research

    RECRUITING

    Dallas, Texas, 75251, United States

  • Central States Research

    RECRUITING

    Tulsa, Oklahoma, 74136, United States

  • Children's Hospital & Medical Center

    RECRUITING

    Omaha, Nebraska, 68114, United States

  • Clinical Research Institute

    NOT_YET_RECRUITING

    Minneapolis, Minnesota, 55402, United States

  • Coastal Heritage Clinical Research

    RECRUITING

    Hinesville, Georgia, 31313, United States

  • Granger Medical Holladay - Holladay Clinic

    RECRUITING

    Salt Lake City, Utah, 84117, United States

  • True North Neurology

    NOT_YET_RECRUITING

    Port Jefferson Station, New York, 11776, United States

  • Velocity Clinical Research, Washington DC

    NOT_YET_RECRUITING

    Washington D.C., District of Columbia, 20016, United States

  • Wasatch Clinical Research, LLC

    RECRUITING

    Salt Lake City, Utah, 84107, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.