Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03766347 |
| Other study ID # |
17-005618 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2018 |
| Est. completion date |
April 3, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Mayo Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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 [age/sex/ethnicity],
- 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 Varni's (1998) PedsQL over the
phone/mail/email.
At follow-up visits 3mo, 6mo, 9mo, 12mo (+/- 1 mo for each time point):
- Attacks/relapses
- 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 phone/mail/email.
