Status:
COMPLETED
NDPH Biomarker Study in Children and Adolescents
Lead Sponsor:
Duke University
Collaborating Sponsors:
International Headache Society
Conditions:
New Persistent Daily Headache
Eligibility:
All Genders
10-18 years
Brief 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 ...
Detailed Description
Subjects age 10-18 with diagnosis of NDPH (International Classification of Headache Disorders D ICHD-3 criteria) will be recruited for the study. Consenting subjects will receive standard headache car...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 29 2025
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT06018025
Start Date
April 15 2024
End Date
May 29 2025
Last Update
December 1 2025
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710