New Daily Persistent Headache (NDPH): Biomarker Study and Therapy in Children and Adolescents
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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 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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 18
Healthy Volunteers: t
View:
• 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
Locations
United States
North Carolina
Duke University Health System
RECRUITING
Durham
Contact Information
Primary
Klaus Werner, MD
klaus.werner@duke.edu
3157480357
Backup
Carlene Moore, PhD
carlene.moore@duke.edu
2053350947
Time Frame
Start Date:2024-03-01
Estimated Completion Date:2025-07-01
Participants
Target number of participants:30
Treatments
NPDH (New Persistent Daily Headache)
Patients with new persistent daily headache (NDPH) ages 10-18 years will be recruited and consented by the study coordinator. Patients will be recruited from patients already established with the Duke Pediatric Neurology clinic with a diagnosis of NDPH, or after their initial visit to establish the diagnosis of NDPH through the Duke, pediatric neurology clinics, personal communication and networking, and through the Duke adult headache clinic.
Healthy (Normal) Controls
Children with normal development, aged 10-18 years, will be identified via the electronic health records of well-child visits in Duke Children's Hospital, community advertising and through networking with colleagues and friends.~Exclusion: 1) History of concussion or head injury 2) Psychiatric disorders 3) History of migraines or other headache disorder treated in the past 4) Known structural brain lesions (tumor, hydrocephalus, congenital anomalies)
Chronic Migraine
Patients between 10-18 yrs of age:~A) Headache (migraine-like or tension-type-like) on ≥15 days/month for \>3 months, and fulfilling criteria B and C, B) Occurring in a patient who has had at least five attacks fulfilling criteria B-D for 1.1 Migraine without aura and/or criteria B and C for 1.2 Migraine with aura C) On ≥8 days/month for \>3 months, fulfilling any of the following (1) criteria C and D for 1.1 Migraine without aura 2) criteria B and C for 1.2 Migraine with aura 3) believed by the patient to be migraine at onset and relieved by a triptan or ergot derivative D) Not better accounted for by another ICHD-3 diagnosis