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

Pro00113907

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.

2024-03-01

2025-07-01

2025-07-01

Recruiting

150

Inclusion 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 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

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '4 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'whole blood, serum,'}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

2024-03-20