Clinical trial NCT06018025: NDPH Biomarker Study in Children and Adolescents
Official title: New Daily Persistent Headache (NDPH): Biomarker Study and Therapy in Children and Adolescents
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: New Persistent Daily Headache
Keywords: NPDH
CGRP
PACAP
BDNF
NGF
TNF-alpha
VIP
biomarker
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: International Headache Society
First posted: 2023-08-30
Enrollment: 30
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 10 patients with NPDH age 10-18yrs 10 patients with chronic migraine age 10-18 yrs 10 normal controls age 10-18 yrs

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 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.

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 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.

Eligibility 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

Primary outcomes:
measure: Change in Calcitonin Gene Related Peptide (CGRP) levels in blood
timeFrame: baseline and 4 months
measure: Change in Pituitary Adenylate Cyclase-activating Peptide (PACAP) levels in blood
timeFrame: baseline and 4 months
measure: Change in Brain derived Neurotrophic factor (BDNF) levels in blood
timeFrame: baseline and 4 months
measure: Change in Nerve Growth Factor (NGF) levels in blood
timeFrame: baseline and 4 months
measure: Change in Tumor Necrosis Factor alpha levels in blood
timeFrame: baseline and 4 months
measure: Change in Vaso Intestinal peptide(VIP) levels in blood
timeFrame: baseline and 4 months
Secondary outcomes:
measure: Disability Scoring
timeFrame: 0 to 4 months
measure: Change in Headache frequency
timeFrame: 0 to 4 months
measure: Screen for Child Anxiety Related Disorders (SCARED)
timeFrame: at enrollment
measure: Patient Health Questionnaire-9 modified for Adolescents administered after recruitment
timeFrame: at enrollment
measure: Change in Headache Pain Intensity
timeFrame: 0 to 4 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: Klaus Werner, MD
role: PRINCIPAL_INVESTIGATOR
References:
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