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.
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.
Study Type
OBSERVATIONAL
Enrollment
38
treatment with CGRP antibody for 4 months
Duke University Health System
Durham, North Carolina, United States
Change in Calcitonin Gene Related Peptide (CGRP) levels in blood
biomarker
Time frame: baseline and 4 months
Change in Pituitary Adenylate Cyclase-activating Peptide (PACAP) levels in blood
protein biomarker
Time frame: baseline and 4 months
Change in Brain derived Neurotrophic factor (BDNF) levels in blood
protein biomarker
Time frame: baseline and 4 months
Change in Nerve Growth Factor (NGF) levels in blood
protein biomarker
Time frame: baseline and 4 months
Change in Tumor Necrosis Factor alpha levels in blood
protein biomarker
Time frame: baseline and 4 months
Change in Vaso Intestinal peptide(VIP) levels in blood
protein biomarker
Time frame: baseline and 4 months
Disability Scoring
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
Time frame: 0 to 4 months
Change in Headache frequency
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.
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Time frame: 0 to 4 months
Screen for Child Anxiety Related Disorders (SCARED)
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.
Time frame: at enrollment
Patient Health Questionnaire-9 modified for Adolescents administered after recruitment
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
Time frame: at enrollment
Change in Headache Pain Intensity
Average severity will be measured using a 10-point pain scale, where a higher score indicates greater pain.
Time frame: 0 to 4 months