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NCT02016222 Clinical Trial

Tear Analysis in the Diagnosis of Multiple Sclerosis

Primary Progressive Multiple Sclerosis Clinical Trial

— LARMES  

Official title:
Tear Analysis in the Diagnosis of Primary Progressive Forms of Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02016222
Other study ID # RC-P0006
Secondary ID
Status Completed
Phase N/A
First received November 22, 2013
Last updated September 19, 2016
Start date April 2011
Est. completion date March 2016

Study information
Verified date September 2016
Source Lille Catholic University
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date March 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• tears sampling

Locations
Country Name City State
France Centre hospitaliere universitaire Bordeaux
France Centre hospitalier universitaire Caen
France Centre hospitalier régional universitaire Clermont-Ferrand
France Centre hospitalier universitaire Dijon
France Centre hospitalier régional universitaire Lille
France Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL) Lille Nord
France Hospices civils de Lyon Lyon
France Assistance Publique - Hôpitaux de Marseille Marseille
France Centre hospitalier universitaire Nancy
France Centre hospitalier universitaire (CHU), Nice Nice Alpes Maritimes
France Centre hospitalier universitaire Nimes
France Centre hospitalier intercommunal Poissy
France Centre hospitalier régional universtaire Strasbourg

Sponsors (2)
Lead Sponsor Collaborator
Lille Catholic University Bayer

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 at baseline and two years after (+/- 2 months) No
Secondary Isoelectrophoretic profile of tears Determination of the stability and prognostic value of isoelectrophoretic profile of tears at inclusion, after 2 years. Baseline and two years after inclusion No
Secondary Isoelectrophoretic profiles of tears by digital recording and analysis of images Baseline and two years after No
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