Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06018025
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2023-08-24
Brief Title:
NDPH Biomarker Study in Children and Adolescents
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
New Daily Persistent Headache NDPH Biomarker Study and Therapy in Children and Adolescents
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 12-18 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None