NCT03121105

Brief Summary

Our objective is to describe the pathologic and MRI findings in a series of patients with presumed demyelinating lesion of the central nervous system.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

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

January 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 19, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

May 7, 2018

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

March 8, 2017

Last Update Submit

May 4, 2018

Conditions

Idiopathic Inflammatory Demyelinating Disorders of the Central Nervous System

Keywords

Idiopathic Inflammatory demyelinating disorders of the central nervous systemMultiple SclerosisNeuromyelitis OpticaMRIpahtological

Outcome Measures

Primary Outcomes (1)

  • pathological

    pathological results: morphologic changes and specific immunostaining

    1 day

Secondary Outcomes (1)

  • MRI (magnetic resonnance Imaging)

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

25 patients with cerebral MRI lesions suggestive of demyelinating lesions

You may qualify if:

  • Presence of brain lesion in MRI suggestive of demyelinating lesions
  • Biopsy analysis revealed active inflammation with active demyelination
  • No known diagnosis of MS or Devic's disease or other diagnosis

You may not qualify if:

  • \- NO

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple SclerosisNeuromyelitis Optica

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesMyelitis, TransverseOptic NeuritisOptic Nerve DiseasesCranial Nerve DiseasesEye Diseases

Study Officials

  • xavier AYRIGNAC, MD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2017

First Posted

April 19, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 31, 2017

Last Updated

May 7, 2018

Record last verified: 2017-03