Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2025-12-25 @ 7:47 PM
Study NCT ID:
NCT06811935
Status:
RECRUITING
Last Update Posted:
2025-02-18
First Post:
2025-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PEDI Pediatric Autoimmune Neuropsychiatric Disorder Associated With Streptococcus Study
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
Feasibility of a Study to Determine the Incidence and Natural History of Children With Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS)
Status:
RECRUITING
Status Verified Date:
2025-02
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:
PANDAS
Brief Summary:
The objective of the Pediatric Epidemiological Data and Incidence (PEDI) PANDAS study is to demonstrate the feasibility of enrollment and retention of subjects in a study to determine the incidence and natural history of children with Pediatric Acute-Onset Neuropsychiatric Syndrome (PANS) with regard to spectrum, course and outcome. The investigators aim to demonstrate they can recruit and retain 85% of children who are eligible for this study. Eligible children are those who fit criteria for PANS and Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcus (PANDAS). Each child will be followed for one year.
Detailed Description:
Specific Aim 1: To establish proof-of-concept of prospectively determining the incidence of PANDAS/PANS and the role of Group A streptococcus (GAS) in this group of disorders.
Specific Aim 1a: To prospectively identify and enroll children with PANDAS and PANS in geographically distinct populations of children in the US in order to determine the incidence and spectrum of these disorders.
Specific Aim 1b: To determine the role of GAS in new onset PANDAS/PANS.
Specific Aim 2: To establish proof-of-concept for studying the clinical course and outcome over the first year of treatment prospectively.
Specific Aim 1a: To prospectively identify and enroll children with PANDAS and PANS in geographically distinct populations of children in the US in order to determine the incidence and spectrum of these disorders.
Specific Aim 1b: To determine the role of GAS in new onset PANDAS/PANS.
Specific Aim 2: To establish proof-of-concept for studying the clinical course and outcome over the first year of treatment prospectively.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Protocol Version 11/22/2024 | OTHER | UW Madison | View | |
| A536756 | OTHER | UW Madison | View | |
| 1R21MH138881-01 | NIH | None | https://reporter.nih.gov/quic… | View |