COMPLETED

NDPH Biomarker Study in Children and Adolescents

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-04-15
Study Completion:2025-05-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06018025

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.

Ages Eligible for Study:10 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients between 10-18 yo with diagnosis of new daily persistent headache (ICHD-3 criteria) who have normal developmental history for age
  2. * Subject and parent legal guardian able to communicate in English, understand and consent to study
  3. * Subject will to undergo monthly injections at home for treatment of NDPH
  4. * Normal neuro imaging
  5. * No prior treatment with CGRP blocking medications or botulinum toxin
  1. * History of Reynauds syndrome
  2. * History of concussion or prior neurosurgery
  3. * Any structural brain lesion including hydrocephalus, congenital anomalies (including chiari malformation)
  4. * History of psychiatric disorders
  5. * History of any headache disorder (including migraine) prior to the diagnosis of NDPH
  6. * Pregnancy
  7. * Prior treatment with any CGRP blocking medication
  8. * Treatment with Botulinum toxin injections previously
  9. * Any other condition that in the opinion of the PI would interfere with the planned study treatment

Contacts and Locations

Principal Investigator

Klaus Werner, MD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Duke University

  • Klaus Werner, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-15
Study Completion Date2025-05-29

Study Record Updates

Study Start Date2024-04-15
Study Completion Date2025-05-29

Terms related to this study

Keywords Provided by Researchers

  • NPDH
  • CGRP
  • PACAP
  • BDNF
  • NGF
  • TNF-alpha
  • VIP
  • biomarker

Additional Relevant MeSH Terms

  • New Persistent Daily Headache