New Persistent Daily Headache
Conditions
Keywords
NPDH, CGRP, PACAP, BDNF, NGF, TNF-alpha, VIP, biomarker
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.
Interventions
DRUGCGRP antibody
treatment with CGRP antibody for 4 months
Sponsors
International Headache Society
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Vaso Intestinal peptide(VIP) levels in blood | baseline and 4 months | protein biomarker |
| Change in Calcitonin Gene Related Peptide (CGRP) levels in blood | baseline and 4 months | biomarker |
| Change in Pituitary Adenylate Cyclase-activating Peptide (PACAP) levels in blood | baseline and 4 months | protein biomarker |
| Change in Brain derived Neurotrophic factor (BDNF) levels in blood | baseline and 4 months | protein biomarker |
| Change in Nerve Growth Factor (NGF) levels in blood | baseline and 4 months | protein biomarker |
| Change in Tumor Necrosis Factor alpha levels in blood | baseline and 4 months | protein biomarker |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Headache frequency | 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. |
| Screen for Child Anxiety Related Disorders (SCARED) | 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. |
| Patient Health Questionnaire-9 modified for Adolescents administered after recruitment | 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 |
| Change in Headache Pain Intensity | 0 to 4 months | Average severity will be measured using a 10-point pain scale, where a higher score indicates greater pain. |
| Disability Scoring | 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 |
Countries
United States
Outcome results
None listed