Trials / Completed
CompletedNCT06018025
NDPH Biomarker Study in Children and Adolescents
New Daily Persistent Headache (NDPH): Biomarker Study and Therapy in Children and Adolescents
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 38 (actual)
- Sponsor
- Duke University · Academic / Other
- Sex
- All
- Age
- 10 Years – 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CGRP antibody | treatment with CGRP antibody for 4 months |
Timeline
- Start date
- 2024-04-15
- Primary completion
- 2025-05-29
- Completion
- 2025-05-29
- First posted
- 2023-08-30
- Last updated
- 2025-12-01
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT06018025. Inclusion in this directory is not an endorsement.