Primary Progressive Multiple SclerosisLARMESNCT02016222
Tear Analysis in the Diagnosis of Multiple Sclerosis
A study testing tears sampling in people with Primary Progressive Multiple Sclerosis, run by Lille Catholic University at 13 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Progressive Multiple Sclerosis
- What is being tested?
- tears sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 13 sitesFrance
- Study dates
- Apr 2011to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Centre hospitaliere universitaire
Bordeaux, 33404
Centre hospitalier universitaire
Caen, 14033
Centre hospitalier régional universitaire
Clermont-Ferrand, 63003
Centre hospitalier universitaire
Dijon, 21079
Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)
Lille, Nord, 59000
Centre hospitalier régional universitaire
Lille, 59037
Hospices civils de Lyon
Lyon, 69229
Assistance Publique - Hôpitaux de Marseille
Marseille, 13354
Centre hospitalier universitaire
Nancy, 54035
Centre hospitalier universitaire (CHU), Nice
Nice, Alpes Maritimes, 06003
Centre hospitalier universitaire
Nîmes, 30029
Centre hospitalier intercommunal
Poissy, 78303
Centre hospitalier régional universtaire
Strasbourg, 67091
About this study
Official title: Tear Analysis in the Diagnosis of Primary Progressive Forms of Multiple Sclerosis
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.
Read the 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.
- Conditions
- Primary Progressive Multiple Sclerosis
- Being tested
- tears sampling
- Keywords
- primary progressive multiple sclerosis, diagnosis, tears, isoelectric focusing, oligoclonal bands
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive, Disease, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tears samplingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Tears sampling | Experimental | Not described Receives: Procedure: tears sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at baseline and two years after (+/- 2 months)
Secondary outcomes (2)
Isoelectrophoretic profile of tears
Determination of the stability and prognostic value of isoelectrophoretic profile of tears at inclusion, after 2 years.
Measured: Baseline and two years after inclusion
Isoelectrophoretic profiles of tears by digital recording and analysis of images
Measured: Baseline and two years after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startApr 2011
- Primary completionMar 2016
- Study completionMar 2016
Why it stopped: Difficulties encountered in recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Progressive Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Patrick Hautecoeur, MD, Principal investigator, Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)Elisabeth Baumelou, MD, Study chair, Groupement des Hôpitaux de l'Institut Catholique de LillePatrick Vermersch, MD, PhD, Principal investigator, Centre Hospitalier Régional, Universitaire de LilleChristine Lebrun-Frenay, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de NiceJérome De Sèze, MD, PhD, Principal investigator, Centre Hospitalier Régional Universitaire de StrasbourgThibaut Moreau, MD, Principal investigator, Centre Hospitalier Universitaire DijonPierre Clavelou, MD, Principal investigator, Centre Hospitalier Régional Universitaire de Clermont-FerrandOlivier Heinzlef, MD, Principal investigator, Centre hospitalier intercommunal de Poissy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016222
- Sponsor's protocol ID
- RC-P0006
- Acronym
- LARMES
- Status last verified
- Jun 2026
- First submitted
- 22 Nov 2013
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tear Analysis in the Diagnosis of Primary Progressive Forms of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02016222
- Acronym / sponsor ID
- LARMES / RC-P0006
- Conditions
- Primary Progressive Multiple Sclerosis
- Keywords
- primary progressive multiple sclerosis, diagnosis, tears, isoelectric focusing, oligoclonal bands
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties encountered in recruiting patients
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Apr 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tears sampling | Experimental | Procedure: tears sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- Asiatic persons
- recurrent forms of the disease
- Persons wearing contact lenses
- Ocular Infection
- Corticoid treatment at least 30 days before sampling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tears sampling | Procedure or surgery | Tears sampling |
Primary outcome
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)
2 secondary outcomes
Isoelectrophoretic profile of tears
Time frame: Baseline and two years after inclusion
Isoelectrophoretic profiles of tears by digital recording and analysis of images
Time frame: Baseline and two years after
Results and safety
The study was stopped early (reason given: Difficulties encountered in recruiting patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Hautecoeur, MD principal investigator
Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)
Elisabeth Baumelou, MD study chair
Groupement des Hôpitaux de l'Institut Catholique de Lille
Patrick Vermersch, MD, PhD principal investigator
Centre Hospitalier Régional, Universitaire de Lille
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tears sampling in people with Primary Progressive Multiple Sclerosis, run by Lille Catholic University at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties encountered in recruiting patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.