Ignite Creation Date:
2024-05-06 @ 12:27 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03766347
Status:
COMPLETED
Last Update Posted:
2024-04-10
First Post:
2018-12-04
Brief Title:
Pediatric NMOSD Observational Study
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Pediatric Neuromyelitis Optica Spectrum Disorder NMOSD 1 Year Observational Study
Status:
COMPLETED
Status Verified Date:
2024-04
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 is being done to develop a database of pediatric patients in order to study the cause early detection and best treatment for neuromyelitis optica spectrum disorder NMOSD in pediatric patients
Detailed Description:
This study is being done to collect information on the natural history of NMOSD in pediatric AQP4-IgG seropositive patients A major restriction in performing drug studies in pediatric patients with NMOSD is limited information on the course of the disease in these patients Collecting clinical information over the course of a 1 year observational study would inform on the natural history of the disease in these patients A repository of pediatric patients with rare diseases can increase knowledge on the natural history of the specific disease assist in identifying appropriate patients fulfilling specified criteria for drug studies and potentially serve as a control group
Timepoints Baseline 3mo 6mo 9mo 12mo - 1 mo for each time point
Baseline data
Demographics agesexethnicity
Clinical presentation information including date of initial diagnosis
Clinical phenotype
Immunotherapy used current and past
Family history of autoimmune diseases
Serological data results
Radiologic data as available
Self-Report Assessments will be
Current impairment as measured by the expanded disability status scale EDSS score self-reported using Ratzker 1997 EDSS Self Report form
Quality of life as measured by the EQ-5D and Varnis 1998 PedsQL over the phonemailemail
At follow-up visits 3mo 6mo 9mo 12mo - 1 mo for each time point
Attacksrelapses
Any hospitalizations
Confirm medications and update records if changes
Self-Report Assessments at follow-up will be
Current impairment as measured by the EDSS score self-reported using Ratzker 1997 EDSS Self Report form
Quality of life as measured by the EQ-5D and PedsQL over the phonemailemail
Timepoints Baseline 3mo 6mo 9mo 12mo - 1 mo for each time point
Baseline data
Demographics agesexethnicity
Clinical presentation information including date of initial diagnosis
Clinical phenotype
Immunotherapy used current and past
Family history of autoimmune diseases
Serological data results
Radiologic data as available
Self-Report Assessments will be
Current impairment as measured by the expanded disability status scale EDSS score self-reported using Ratzker 1997 EDSS Self Report form
Quality of life as measured by the EQ-5D and Varnis 1998 PedsQL over the phonemailemail
At follow-up visits 3mo 6mo 9mo 12mo - 1 mo for each time point
Attacksrelapses
Any hospitalizations
Confirm medications and update records if changes
Self-Report Assessments at follow-up will be
Current impairment as measured by the EDSS score self-reported using Ratzker 1997 EDSS Self Report form
Quality of life as measured by the EQ-5D and PedsQL over the phonemailemail
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