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Hope for kids with constant headaches: new treatment studied

NCT ID NCT06018025

Disease control Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at a rare type of daily headache in children and teens called NDPH. Researchers used standard headache medicines and measured certain proteins in the blood to see if they change with treatment. The goal was to better understand the condition and see how well the medicines work.

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.

Participants

38 people

The number who actually took part.

Started

Apr 2024

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

10 patients with NPDH age 10-18yrs 10 patients with chronic migraine age 10-18 yrs 10 normal controls age 10-18 yrs

Ages

10 to 18 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Patients between 10-18 yo with diagnosis of new daily persistent headache (ICHD-3 criteria) who have normal developmental history for age * Subject and parent legal guardian able to communicate in English, understand and consent to study * Subject will to undergo monthly injections at home for treatment of NDPH * Normal neuro imaging * No prior treatment with CGRP blocking medications or botulinum toxin Exclusion Criteria: * History of Reynauds syndrome * History of concussion or prior neurosurgery * Any structural brain lesion including hydrocephalus, congenital anomalies (including chiari malformation) * History of psychiatric disorders * History of any headache disorder (including migraine) prior to the diagnosis of NDPH * Pregnancy * Prior treatment with any CGRP blocking medication * Treatment with Botulinum toxin injections previously * Any other condition that in the opinion of the PI would interfere with the planned study treatment

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Conditions

The condition(s) this trial relates to.

headache disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

New persistent daily headache

Contacts and locations

Locations

  • Duke University Health System

    Durham, North Carolina, 27710, United States