CompletedNot Applicable

NDPH Biomarker Study in Children and Adolescents

United States38 participantsStarted 2024-04-15

Plain-language summary

This study will recruit pediatric patients with NDPH (New Daily Persistent Headache), characterize their headache in a standard manner, and treat the NDPH with standard medications used for treatment of headaches in this population. Response to treatment with CGRP blocking Ab medications will be evaluated. Biomarkers related to headache disorders will be measured before and after treatment.

Who can participate

Age range

10 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Calcitonin Gene Related Peptide (CGRP) levels in blood

Timeframe: baseline and 4 months

Change in Pituitary Adenylate Cyclase-activating Peptide (PACAP) levels in blood

Timeframe: baseline and 4 months

Change in Brain derived Neurotrophic factor (BDNF) levels in blood

Timeframe: baseline and 4 months

Change in Nerve Growth Factor (NGF) levels in blood

Timeframe: baseline and 4 months

Change in Tumor Necrosis Factor alpha levels in blood

Timeframe: baseline and 4 months

Change in Vaso Intestinal peptide(VIP) levels in blood

Timeframe: baseline and 4 months

Trial details

NCT IDNCT06018025

SponsorDuke University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-05-29

View on ClinicalTrials.gov More New Persistent Daily Headache trials

Plain-language summary

Who can participate

Age range

10 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Calcitonin Gene Related Peptide (CGRP) levels in blood

Timeframe: baseline and 4 months

Change in Pituitary Adenylate Cyclase-activating Peptide (PACAP) levels in blood

Timeframe: baseline and 4 months

Change in Brain derived Neurotrophic factor (BDNF) levels in blood

Timeframe: baseline and 4 months

Change in Nerve Growth Factor (NGF) levels in blood

Timeframe: baseline and 4 months

Change in Tumor Necrosis Factor alpha levels in blood

Timeframe: baseline and 4 months

Change in Vaso Intestinal peptide(VIP) levels in blood

Timeframe: baseline and 4 months