NDPH Biomarker Study in Children and Adolescents

Duke University

Status: Enrolling

Conditions: New Persistent Daily Headache

Treatments: Drug: CGRP antibody

Study type: Observational

Funder types: Other

Identifiers

NCT06018025

Pro00113907

Details and patient eligibility

About

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.

Full 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 care and treatment, including treatment with CGRP Blocking Ab medications. Blood will be drawn before and after treatment, with assessment of Calcitonin Gene Related Peptid, Pituitary Adenylate Cyclase Activating Peptid (PACAP), Brain derived Neurotrophic factor (BDNF), Nerve Growth Factor (NGF), and Tumor Necrosis Factor alpha, and Vasointestinal peptic (VIP) before and after treatment.

Enrollment: 30 estimated patients

Sex: All

Ages: 10 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

30 participants in 3 patient groups

NPDH (New Persistent Daily Headache)

Description:

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.

Treatment:

Drug: CGRP antibody

Healthy (Normal) Controls

Description:

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

Description:

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

Treatment:

Drug: CGRP antibody