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Tear Analysis in the Diagnosis of Multiple Sclerosis (LARMES)

Primary Purpose

Primary Progressive Multiple Sclerosis

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

tears sampling

About this trial

This is an interventional diagnostic trial for Primary Progressive Multiple Sclerosis focused on measuring primary progressive multiple sclerosis, diagnosis, tears, isoelectric focusing, oligoclonal bands

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years old or more
Progressive neurological deficit after 12 months
At least 9 T2 brain lesions of minimum 3 mm evidenced by MRI and/or four or more T2 lesions of minimum 3 mm with positive Visual Evoked Potential and/or positive spinal cord MRI (at least two focal T2 lesions)

Exclusion Criteria:

Asiatic persons
recurrent forms of the disease
Persons wearing contact lenses
Ocular Infection
Corticoid treatment at least 30 days before sampling
immunosuppressive or immunomodulatory treatment 3 months before sampling

Sites / Locations

Centre hospitalier universitaire (CHU), Nice
Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)
Centre hospitaliere universitaire
Centre hospitalier universitaire
Centre hospitalier régional universitaire
Centre hospitalier universitaire
Centre hospitalier régional universitaire
Hospices civils de Lyon
Assistance Publique - Hôpitaux de Marseille
Centre hospitalier universitaire
Centre hospitalier universitaire
Centre hospitalier intercommunal
Centre hospitalier régional universtaire

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tears sampling

Arm Description

Outcomes

Primary Outcome Measures

Concordance between the quantification of oligoclonal IgG bands by isoelectric focusing in tears and in the cerebrospinal fluid in patients with primary progressive multiple sclerosis

Secondary Outcome Measures

Isoelectrophoretic profile of tears

Determination of the stability and prognostic value of isoelectrophoretic profile of tears at inclusion, after 2 years.

Isoelectrophoretic profiles of tears by digital recording and analysis of images

Full Information

NCT ID

NCT02016222

First Posted

November 22, 2013

Last Updated

September 19, 2016

Sponsor

Lille Catholic University

Collaborators

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT02016222

Brief Title

Tear Analysis in the Diagnosis of Multiple Sclerosis

Acronym

LARMES

Official Title

Tear Analysis in the Diagnosis of Primary Progressive Forms of Multiple Sclerosis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lille Catholic University

Collaborators

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

In the primary progressive multiple sclerosis, the detection of oligoclonal bands in cerebrospinal fluid is critical for the diagnosis. However, lumbar puncture for cerebrospinal fluid collection is considered relatively invasive. Our hypothesis is that oligoclonal bands detection in tears is possible and useful for the diagnosis of multiple sclerosis.

Detailed Description

The objective of the present study is to assess concordance between oligoclonal bands detection in tears and in cerebrospinal fluid. We will include patients with primary progressive multiple sclerosis and we will compare results of oligoclonal bands detection by isoelectric focusing in cerebrospinal fluid and tears. Tears will be collected using a Schirmer strip. This would circumvent the practice of invasive lumbar punctures currently used in multiple sclerosis diagnosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Progressive Multiple Sclerosis

Keywords

primary progressive multiple sclerosis, diagnosis, tears, isoelectric focusing, oligoclonal bands

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tears sampling

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

tears sampling

Primary Outcome Measure Information:

Title

Concordance between the quantification of oligoclonal IgG bands by isoelectric focusing in tears and in the cerebrospinal fluid in patients with primary progressive multiple sclerosis

Time Frame

at baseline and two years after (+/- 2 months)

Secondary Outcome Measure Information:

Title

Isoelectrophoretic profile of tears

Description

Determination of the stability and prognostic value of isoelectrophoretic profile of tears at inclusion, after 2 years.

Time Frame

Baseline and two years after inclusion

Title

Isoelectrophoretic profiles of tears by digital recording and analysis of images

Time Frame

Baseline and two years after

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years old or more Progressive neurological deficit after 12 months At least 9 T2 brain lesions of minimum 3 mm evidenced by MRI and/or four or more T2 lesions of minimum 3 mm with positive Visual Evoked Potential and/or positive spinal cord MRI (at least two focal T2 lesions) Exclusion Criteria: Asiatic persons recurrent forms of the disease Persons wearing contact lenses Ocular Infection Corticoid treatment at least 30 days before sampling immunosuppressive or immunomodulatory treatment 3 months before sampling

Overall Study Officials: