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Completed

NCT Number: NCT06018025

NDPH Biomarker Study in Children and Adolescents

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.

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Key information

Conditions

New Persistent Daily Headache

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Health System

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CGRP antibody

Drug

treatment with CGRP antibody for 4 months

Primary outcomes

  1. Change in Calcitonin Gene Related Peptide (CGRP) levels in blood

    Time frame: baseline and 4 months

    biomarker

  2. Change in Pituitary Adenylate Cyclase-activating Peptide (PACAP) levels in blood

    Time frame: baseline and 4 months

    protein biomarker

  3. Change in Brain derived Neurotrophic factor (BDNF) levels in blood

    Time frame: baseline and 4 months

    protein biomarker

  4. Change in Nerve Growth Factor (NGF) levels in blood

    Time frame: baseline and 4 months

    protein biomarker

  5. Change in Tumor Necrosis Factor alpha levels in blood

    Time frame: baseline and 4 months

    protein biomarker

  6. Change in Vaso Intestinal peptide(VIP) levels in blood

    Time frame: baseline and 4 months

    protein biomarker

Secondary outcomes

  1. Disability Scoring

    Time frame: 0 to 4 months

    Changes in the Disability Scoring using the Pediatric Migraine Disability Assessment(PedMIDAS) will be recorded at the baseline visit (prior to first CGRP-AB treatment) and 4 months after receiving CGRP-AB treatment. Disability Grade ; 0 to 10. Little to none ; 11 to 30. Mild ; 31 to 50. Moderate ; Greater than 50. Severe

  2. Change in Headache frequency

    Time frame: 0 to 4 months

    Self-reported headache frequency will be recorded as the number of headaches in the prior month, collected at baseline and 4 months after last CGRP-AB treatment. The patients will be encouraged to keep a headache diary.

  3. Screen for Child Anxiety Related Disorders (SCARED)

    Time frame: at enrollment

    41 items and 5 factors that parallel the DSM-IV classification of anxiety disorders. A total score of 0-9, normal or no anxiety; 10-18, mild to moderate anxiety; 19-29, moderate to severe anxiety; and 30-63, severe anxiety.

  4. Patient Health Questionnaire-9 modified for Adolescents administered after recruitment

    Time frame: at enrollment

    Scores of 0-4 points normal or minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression and 20-27 severe depression

  5. Change in Headache Pain Intensity

    Time frame: 0 to 4 months

    Average severity will be measured using a 10-point pain scale, where a higher score indicates greater pain.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • International Headache Society

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 30, 2023
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.