NCT03766347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2024

Completed
Last Updated

April 10, 2024

Status Verified

April 1, 2024

Enrollment Period

6.2 years

First QC Date

December 4, 2018

Last Update Submit

April 8, 2024

Conditions

Neuromyelitis OpticaNMO Spectrum Disorder

Keywords

PediatricAquaporin-4AQP4NMOSDNMONeuromyelitis Optica

Outcome Measures

Primary Outcomes (1)

  • Time to relapse

    Relapse events of NMOSD defined by clinical worsening of neurological symptoms and treatment.

    One year.

Study Arms (1)

Pediatric Neuromyelitis Optica

Participants under the age of 18 that are positive for Aquaporin-4 antibody.

Eligibility Criteria

Age2 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Any pediatric patients that have tested positive for AQP4 antibody regardless of geographic location.

You may qualify if:

  • AQP4 positive
  • Ability to give informed consent by patient or caregiver

You may not qualify if:

  • \- Inability to complete required forms via phone, mail, or email.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

MeSH Terms

Conditions

Neuromyelitis Optica

Condition Hierarchy (Ancestors)

Myelitis, TransverseDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesOptic NeuritisOptic Nerve DiseasesCranial Nerve DiseasesDemyelinating DiseasesEye DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Sean J Pittock, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicpal Investigator

Study Record Dates

First Submitted

December 4, 2018

First Posted

December 6, 2018

Study Start

February 1, 2018

Primary Completion

April 3, 2024

Study Completion

April 3, 2024

Last Updated

April 10, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)