Biomarker study for children and adolescents with New Daily Persistent Headache
New Daily Persistent Headache (NDPH): Biomarker Study and Therapy in Children and Adolescents
Duke University · NCT06018025
This study is testing how well standard headache treatments work for kids and teens with New Daily Persistent Headache while looking at certain blood markers to see if they relate to how well the treatments help.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 10 Years to 18 Years |
| Sex | All |
| Sponsor | Duke University (other) |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT06018025 on ClinicalTrials.gov |
What this trial studies
This observational study aims to recruit pediatric patients aged 10-18 diagnosed with New Daily Persistent Headache (NDPH) to characterize their condition and evaluate treatment responses. Participants will receive standard headache care, including CGRP blocking antibody medications, while their biomarkers related to headache disorders will be measured before and after treatment. Blood samples will be analyzed for various biomarkers, including Calcitonin Gene Related Peptide and Brain-derived Neurotrophic Factor, to assess their relationship with treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 10-18 with a diagnosis of NDPH who have not previously received CGRP blocking medications.
Not a fit: Patients with a history of other headache disorders, structural brain lesions, or psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for children and adolescents suffering from NDPH.
How similar studies have performed: Other studies have shown promise in using CGRP blocking medications for headache disorders, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Durham, North Carolina
- Duke University Health System — Durham, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Klaus Werner, MD — Duke University
- Study coordinator: Klaus Werner, MD
- Email: klaus.werner@duke.edu
- Phone: 3157480357
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: New Persistent Daily Headache, NPDH, CGRP, PACAP, BDNF, NGF, TNF-alpha, VIP