An interventional study of Measure of visual acuity and Interferometry in Amyotrophic Lateral Sclerosis, sponsored by University Hospital, Tours. Completed at 3 sites in France. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by University Hospital, Tours · Not applicable, Interventional, and Health services research
Among 132 studies in Amyotrophic Lateral Sclerosis with a site in France — 28 open to participants now, 36 under way, 5 of them phase 3. Amyotrophic Lateral Sclerosis · France.
Among the 132 studies in Amyotrophic Lateral Sclerosis with a site in France, this one is the 60th largest by enrollment of the 103 interventional ones, is one of 14 that started in 2021, is one of 47 with no phase, and was the 85th registered.
978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.
This study's enrollment of 55 is above the median of 38 across 662 interventional studies indexed under Amyotrophic Lateral Sclerosis.
Browse Amyotrophic Lateral Sclerosis studies →28 of the 132 studies in Amyotrophic Lateral Sclerosis with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 192 Amyotrophic Lateral Sclerosis studies recruiting now, 117 (61%) set no upper age limit and 23 (12%) stop at 75 or younger; 15 take children under 18; 55 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · healthy volunteers too.
The full table on the hub →132 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 14 started in 2021.
Median enrollment 83 across the 103 interventional studies, 138 across the 29 observational. Of the 79 that completed or were terminated, 21 (27%) have results posted.
44 of 132 have an industry lead sponsor. The 10 most frequent:
University Hospital, Tours is the lead sponsor of 307 studies on the registry; 79 are open to participants now.
University Hospital, Tours has 8 studies filed under Amyotrophic Lateral Sclerosis — fewer than ten, so there is no comparison to draw.
11 of the studies in Amyotrophic Lateral Sclerosis with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04856982Phase 3BiogenStudy to Learn If Tofersen (BIIB067) Can Delay ALS Symptoms and About Its Safety in Adults With a SOD1 Gene Mutation Who Have Not Yet Developed ALS Symptoms | 2027-08-07 |
| NCT06249412Groupe Hospitalier du HavreThe Importance of Positive Expiratory Pressure Associated With the In-exsufflator in ALS Patients | 2026-12-01 |
| NCT05632757Assistance Publique Hopitaux De MarseilleAnticipated Patient and Caregiver Burden | 2026-12-22 |
| NCT05819931University Hospital, ToulouseBreathing With Amyotrophic Lateral Sclerosis | 2026-12-31 |
| NCT07091799University Hospital, BordeauxInterest of Measuring P2X4 Receptors on Blood Monocytes as a Diagnostic Marker in Amyotrophic Lateral Sclerosis: P2X4 as a Diagnostic Biomarker for ALS | 2027-01 |
Among the 132 studies in Amyotrophic Lateral Sclerosis with a site in France, from their registry updates:
Amyotrophic Lateral Sclerosis (ALS) is the most common neurodegenerative disease affecting the motor neuron. Currently, there is no diagnostic test and no examination that can predict the evolution of this pathology. The search for diagnostic and prognostic biomarkers is therefore essential for a better understanding of the pathophysiology of ALS, which remains poorly understood, and also for better clinical management. The ocular surface, made up of liquid elements, tears, and cells, is an accessible anatomical-physiological entity that has demonstrated its usefulness in the identification of biomarkers in neurodegenerative diseases such as Parkinson's or Alzheimer's. To date, no study has explored the ocular surface as a biomarker in ALS
Case group selection criteria :
Inclusion Criteria:
Exclusion Criteria:
Control group selection criteria:
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The procedure, specific to the study, consists in taking samples of tears and cells at inclusion, 3 months after inclusion and 6 months after inclusion on patients with Amyotrophic Lateral Sclerosis
Other: Measure of visual acuity · Other: Interferometry · Other: Samples of basal tears · Other: Central corneal sensitivity · Other: Slit lamp examination and undilated fundus · Other: Conjunctival impression · Other: Evaluation of the corneal innervation
The procedure, specific to the study, consists in taking samples of tears and cells at inclusion, 3 months after inclusion and 6 months after inclusion on patients without neurological disease
Other: Measure of visual acuity · Other: Interferometry · Other: Samples of basal tears · Other: Central corneal sensitivity · Other: Slit lamp examination and undilated fundus · Other: Conjunctival impression · Other: Evaluation of the corneal innervation
ETDRS and Parinaud scale
Non-contact exam measuring N.I.B.U.T (Non-invasive break-up time), quantitative and qualitative evaluation of the meibomian glands and quantitative evaluation of the tear meniscus
Collection of basal tears without instillation of anesthetic with a Schirmer strip for 5 minutes and by microcapillary
Central corneal sensitivity using a Cochet-Bonnet esthesiometer (Luneau©)
Slit lamp examination and undilated fundus
Conjunctival impression with anesthetic instillation
Contact corneal confocal microscopy
Metabolome profile in tears for the diagnosis and prognosis of ALS.
Once the composition in metabolites (i.e. tear metabolome) is determined, statistical univariate and multivariate analyses will aim to determine if the tear metabolome can cluster ALS patients and controls and therefore can be used as a diagnosis biomarker
Time frame: Baseline
Metabolome profile in intra-cellular contents for the diagnosis and prognosis of ALS.
Once the composition in metabolites in conjunctival cells is determined, statistical univariate and multivariate analyses will aim to determine if the tear metabome can cluster ALS patients and controls and therefore can be used as a diagnosis biomarker.
Time frame: Baseline
Lipidome profile in tears for the diagnosis and prognosis of ALS.
Once the composition in lipids (i.e. tear lipidome) is determined, statistical univariate and multivariate analyses will aim to determine if the tear lipidome can cluster ALS patients and controls and therefore can be used as a diagnosis biomarker
Time frame: Baseline
Lipidome profile in intra-cellular contents for the diagnosis and prognosis of ALS.
Once the composition in lipids in conjunctival cells is determined, statistical univariate and multivariate analyses will aim to determine if the tear lipidome can cluster ALS patients and controls and therefore can be used as a diagnosis biomarker.
Time frame: Baseline
Evolution of the ocular surface metabolites during ALS progression using ultra-high performance liquid chromatography coupled with mass spectrometry
By carrying out a longitudinal analysis in ALS cases, the modification in tear and cells metabo-lipidome will be assessed at three time-points (at diagnosis, at month 3 and 6) and will correlated with bioclinical criteria of ALS progression (i.e. % of weight loss, % of slope of progression of the ALS-FRS-r score and % of decrease in forced vital capacity). This analysis will aim to search for analytes that can predict ALS progression (i.e. prognosis biomarker).
Time frame: Baseline
Evolution of the ocular surface lipids during ALS progression using ultra-high performance liquid chromatography coupled with mass spectrometry
By carrying out a longitudinal analysis in ALS cases, the modification in tear and cells metabo-lipidome will be assessed at three time-points (at diagnosis, at month 3 and 6) and will correlated with bioclinical criteria of ALS progression (i.e. % of weight loss, % of slope of progression of the ALS-FRS-r score and % of decrease in forced vital capacity). This analysis will aim to search for analytes that can predict ALS progression (i.e. prognosis biomarker).
Time frame: Baseline
Plan to share: No
Ran from Sep 2021 to primary completion in Sep 2023, 24 months.
Of 134 non-industry interventional studies with no phase under Amyotrophic Lateral Sclerosis, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 60. This study's 24 months is below that.
Counting every sponsor, half of 154 studies reached it within 35 months; a quarter within 23 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Amyotrophic Lateral Sclerosis →