NDPH Biomarker Study in Children and Adolescents

Description

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.

Conditions

New Persistent Daily Headache

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

New Daily Persistent Headache (NDPH): Biomarker Study and Therapy in Children and Adolescents

NDPH Biomarker Study in Children and Adolescents

Condition
New Persistent Daily Headache
Intervention / Treatment

-

Contacts and Locations

Durham

Duke University Health Sustem, Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patients between 12-18 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
  • * 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

Ages Eligible for Study

12 Years to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Duke University,

Klaus Werner, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

2025-07-01