Amyotrophic Lateral SclerosisMETABOMUNCT02670226
Muscular Biomarkers in Amyotrophic Lateral Sclerosis
A study testing Samples in people with Amyotrophic Lateral Sclerosis, run by University Hospital, Tours at 2 sites in France.
Trial summary
The first objective is to find some biomarkers, or a profile of biomarkers of ALS to help to diagnosis. The second objective is to better understand the pathogenesis of this disease by the exploration of muscle, blood and satellite cells metabolomes and transcriptomes. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Mar 2016to 9 Dec 2019
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≥ 75 years
- ALS according to the El Escorial criteria
- Patients affiliated to social security scheme
- Informed consent signed by the patient
- Age ≥ 18 years and ≥ 75 years
- No neuronal disease
- Patients affiliated to social security scheme
- Informed consent signed by the patient
Who cannot join
- Pregnant or breastfeeding women
- Contraindication to biopsy
- Contraindication to local anesthesia
- Treatment with oral or injectable anticoagulants, antiplatelet (except aspirin)
- Unbalanced Diabetes
- Systemic corticosteroid treatment
Show all 14Show fewer
- Treatment against cramps or twitching may affect muscle metabolism
- Control group selection criteria:
- Pregnant or breastfeeding women
- Contraindication to biopsy
- Treatment with oral or injectable anticoagulants, antiplatelet (except aspirin)
- Unbalanced Diabetes
- Systemic corticosteroid treatment
- Treatment against cramps or twitching may affect muscle metabolism
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service de chirurgie orthopédique et traumatologique, CHRU de TOURS
Tours, 37044
Service de Neurologie, CHRU de TOURS
Tours, 37044
About this study
Official title: Metabolomics and Transcriptomics Approaches to Identify Muscular Biomarkers in Amyotrophic Lateral Sclerosis
The first objective is to find some biomarkers, or a profile of biomarkers of ALS to help to diagnosis. The second objective is to better understand the pathogenesis of this disease by the exploration of muscle, blood and satellite cells metabolomes and transcriptomes.
Read the detailed description
Amyotrophic Lateral Sclerosis (ALS), the most common MND, is a fatal adult-onset neuromuscular disease. Due to clinical heterogeneity and absence of biological tools to diagnose ALS, the delay between the first symptoms and diagnosis averages 9-13 months. A group of pathophysiological processes, including oxidative stress and glutamate-mediated excitotoxicity contribute to cell death, but the triggering factor, the timing and the interaction of different cellular events await elucidation [2]. Unknown pathogenesis for most patients means few available treatments. The search for biomarkers that can aid diagnosis, characterize phenotype, define pathophysiology, identify endpoints in trials and measure disease progression is of utmost importance for the field. Some studies have advocated that muscle per se may be impaired by pathogenesis of the diseases. Muscle has been poorly studied and its central role in energetic metabolism suggests that this tissue, quite easily available, should be more analyzed to find biomarkers and to compare muscular metabolism with those of brain and overall body. Specific aims of our subjects are:
Specific aims are focused on:
- the acquisition of metabolites profiles of the muscle, blood and satellite cells using an analytical platform enable a deep exploration. For that, the use of three analytical modalities (NMR, mass spectrometry coupled to GC or UPLC) ensures the best coverage of the metabolite population with a high range of concentration variability and molecular diversity.
- the building of metabolites profiles models that discriminate pathological and control situations.
- the identification of metabolites implicated in the discriminant model.
- the generation of metabolism pathways hypothesis related to the discriminant model.
- the acquisition of transcriptomics data to confirm and add complementary results to metabolomics data
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Samples
- Keywords
- Amyotrophic Lateral Sclerosis, Muscle metabolism, Metabolomics, Transcriptomics
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplesOther
Blood samples, muscle biopsy
| Study group | Role | What they receive |
|---|---|---|
| Case group | Other | The intervention, specific to the study, is to take samples at baseline on patients with Amyotrophic Lateral Sclerosis Receives: Other: Samples |
| Control group | Other | The intervention, specific to the study, is to take samples at baseline on patients without neurological disease Receives: Other: Samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic signature of muscle
Metabolomics profile using NMR and LC-HRMS
Measured: At baseline
Metabolic signature of blood
Metabolomics profile using NMR and LC-HRMS
Measured: At baseline
Metabolic signature of satellites cells
Metabolomics profile using NMR and LC-HRMS
Measured: At baseline
Secondary outcomes (1)
Expression levels of targeted genes using transcriptomics
Choice of genes based on results obtained by metabolomics approaches
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study start29 Mar 2016
- Primary completion15 Oct 2019
- Study completion9 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène BLASCO, MD, Study director, helene.blasco@univ-tours.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670226
- Sponsor's protocol ID
- PHAO15-HB-METABOMU
- Other IDs
- 2015-A01629-40, 151550B-31, 2016-R3
- Acronym
- METABOMU
- Status last verified
- Dec 2025
- First submitted
- 14 Jan 2016
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lanznaster D, Bruno C, Bourgeais J, Emond P, Zemmoura I, Lefevre A, Reynier P, Eymieux S, Blanchard E, Vourc'h P, Andres CR, Bakkouche SE, Herault O, Favard L, Corcia P, Blasco H. Metabolic Profile and Pathological Alterations in the Muscle of Patients with Early-Stage Amyotrophic Lateral Sclerosis. Biomedicines. 2022 Jun 2;10(6):1307. doi: 10.3390/biomedicines10061307.
PubMed 35740329
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomics and Transcriptomics Approaches to Identify Muscular Biomarkers in Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT02670226
- Acronym / sponsor ID
- METABOMU / PHAO15-HB-METABOMU
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic Lateral Sclerosis, Muscle metabolism, Metabolomics, Transcriptomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 29 Mar 2016 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 1 Feb 2016 (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.
The first objective is to find some biomarkers, or a profile of biomarkers of ALS to help to diagnosis. The second objective is to better understand the pathogenesis of this disease by the exploration of muscle, blood and satellite cells metabolomes and transcriptomes.
Detailed description
Amyotrophic Lateral Sclerosis (ALS), the most common MND, is a fatal adult-onset neuromuscular disease. Due to clinical heterogeneity and absence of biological tools to diagnose ALS, the delay between the first symptoms and diagnosis averages 9-13 months. A group of pathophysiological processes, including oxidative stress and glutamate-mediated excitotoxicity contribute to cell death, but the triggering factor, the timing and the interaction of different cellular events await elucidation [2]. Unknown pathogenesis for most patients means few available treatments. The search for biomarkers that can aid diagnosis, characterize phenotype, define pathophysiology, identify endpoints in trials and measure disease progression is of utmost importance for the field. Some studies have advocated that muscle per se may be impaired by pathogenesis of the diseases. Muscle has been poorly studied and its central role in energetic metabolism suggests that this tissue, quite easily available, should be more analyzed to find biomarkers and to compare muscular metabolism with those of brain and overall body. Specific aims of our subjects are:
Specific aims are focused on:
- the acquisition of metabolites profiles of the muscle, blood and satellite cells using an analytical platform enable a deep exploration. For that, the use of three analytical modalities (NMR, mass spectrometry coupled to GC or UPLC) ensures the best coverage of the metabolite population with a high range of concentration variability and molecular diversity.
- the building of metabolites profiles models that discriminate pathological and control situations.
- the identification of metabolites implicated in the discriminant model.
- the generation of metabolism pathways hypothesis related to the discriminant model.
- the acquisition of transcriptomics data to confirm and add complementary results to metabolomics data
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | Other | Other: SamplesThe intervention, specific to the study, is to take samples at baseline on patients with Amyotrophic Lateral Sclerosis |
| Control group | Other | Other: SamplesThe intervention, specific to the study, is to take samples at baseline on patients without neurological disease |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years and ≥ 75 years
- ALS according to the El Escorial criteria
- Patients affiliated to social security scheme
- Informed consent signed by the patient
- Age ≥ 18 years and ≥ 75 years
Key exclusion criteria (14 listed)
- Pregnant or breastfeeding women
- Contraindication to biopsy
- Contraindication to local anesthesia
- Treatment with oral or injectable anticoagulants, antiplatelet (except aspirin)
- Unbalanced Diabetes
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 |
|---|---|---|
| SamplesBlood samples, muscle biopsy | Other | Case group, Control group |
Primary outcome
Metabolic signature of muscle
Time frame: At baseline
Metabolomics profile using NMR and LC-HRMS
Metabolic signature of blood
Time frame: At baseline
Metabolomics profile using NMR and LC-HRMS
Metabolic signature of satellites cells
Time frame: At baseline
Metabolomics profile using NMR and LC-HRMS
1 secondary outcome
Expression levels of targeted genes using transcriptomics
Time frame: At baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 35740329Lanznaster D, Bruno C, Bourgeais J, Emond P, Zemmoura I, Lefevre A, Reynier P, Eymieux S, Blanchard E, Vourc'h P, Andres CR, Bakkouche SE, Herault O, Favard L, Corcia P, Blasco H. Metabolic Profile and Pathological Alterations in the Muscle of Patients with Early-Stage Amyotrophic Lateral Sclerosis. Biomedicines. 2022 Jun 2;10(6):1307. doi: 10.3390/biomedicines10061307.
- Individual participant dataSharing planned: No
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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.
Hélène BLASCO, MD study director
helene.blasco@univ-tours.fr
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Samples in people with Amyotrophic Lateral Sclerosis, run by University Hospital, Tours at 2 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 8 inclusion and 14 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: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Metabolic signature of muscle (time frame: At baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02670226, which also lists 1 linked publication.
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 22 Dec 2025.