New Daily Persistent Headache (NDPH): Biomarker Study and Therapy in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change in Pituitary Adenylate Cyclase-activating Peptide (PACAP) levels in blood
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
NPDH (New Persistent Daily Headache)
Patients with new persistent daily headache (NDPH) ages 10-18 years will be recruited and consented by the study coordinator. Patients will be recruited from patients already established with the Duke Pediatric Neurology clinic with a diagnosis of NDPH, or after their initial visit to establish the diagnosis of NDPH through the Duke, pediatric neurology clinics, personal communication and networking, and through the Duke adult headache clinic.
干预措施: CGRP antibody (Drug)
Chronic Migraine
Patients between 10-18 yrs of age:
A) Headache (migraine-like or tension-type-like) on ≥15 days/month for >3 months, and fulfilling criteria B and C, B) Occurring in a patient who has had at least five attacks fulfilling criteria B-D for 1.1 Migraine without aura and/or criteria B and C for 1.2 Migraine with aura C) On ≥8 days/month for >3 months, fulfilling any of the following (1) criteria C and D for 1.1 Migraine without aura 2) criteria B and C for 1.2 Migraine with aura 3) believed by the patient to be migraine at onset and relieved by a triptan or ergot derivative D) Not better accounted for by another ICHD-3 diagnosis
干预措施: CGRP antibody (Drug)
结局指标
主要结局
Change in Pituitary Adenylate Cyclase-activating Peptide (PACAP) levels in blood
时间窗: baseline and 4 months
protein biomarker
Change in Calcitonin Gene Related Peptide (CGRP) levels in blood
时间窗: baseline and 4 months
biomarker
Change in Tumor Necrosis Factor alpha levels in blood
时间窗: baseline and 4 months
protein biomarker
Change in Vaso Intestinal peptide(VIP) levels in blood
时间窗: baseline and 4 months
protein biomarker
Change in Brain derived Neurotrophic factor (BDNF) levels in blood
时间窗: baseline and 4 months
protein biomarker
Change in Nerve Growth Factor (NGF) levels in blood
时间窗: baseline and 4 months
protein biomarker
次要结局
- Screen for Child Anxiety Related Disorders (SCARED)(at enrollment)
- Disability Scoring(0 to 4 months)
- Patient Health Questionnaire-9 modified for Adolescents administered after recruitment(at enrollment)
- Change in Headache frequency(0 to 4 months)
- Change in Headache Pain Intensity(0 to 4 months)