New Therapeutic Strategy in ALS Based on Metabolic Status and Associated Metabolic Pathways. (METABOCALS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03984708 |
Recruitment Status :
Recruiting
First Posted : June 13, 2019
Last Update Posted : September 30, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amyotrophic Lateral Sclerosis | Other: Samples Other: Indirect calorimetry Other: Electrical bioimpedance | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 90 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | New Therapeutic Strategy in ALS Based on Metabolic Status and Associated Metabolic Pathways. |
Actual Study Start Date : | January 27, 2020 |
Estimated Primary Completion Date : | January 2023 |
Estimated Study Completion Date : | January 2024 |

Arm | Intervention/treatment |
---|---|
Case group
The intervention, specific to the study, is to take samples at baseline on patients with Amyotrophic Lateral Sclerosis
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Other: Samples
Blood sample, skin biopsy Other: Indirect calorimetry Measurement of energy expenditure by indirect calorimetry Other: Electrical bioimpedance Measurement of electrical bioimpedance |
Control group
The intervention, specific to the study, is to take samples at baseline on patients without neurological disease
|
Other: Samples
Blood sample, skin biopsy |
- Metabolic signature of fibroblast : concentrations of molecules detected by mass spectrometry [ Time Frame: Baseline ]The metabolomic profile of fibroblast represents the combination of the different molecules detected/quantified by mass spectrometry
- Metabolic signature of blood : concentrations of molecules detected by mass spectrometry [ Time Frame: Baseline ]The metabolomic profile of blood represents the combination of the different molecules detected/quantified by mass spectrometry
- Expression levels of targeted molecules using transcriptomics [ Time Frame: Baseline ]Choice of molecules based on results obtained by metabolomics approaches

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Case group selection criteria:
Inclusion Criteria:
- Age ≥ 18 years and ≥ 75 years
- ALS according to the El Escorial criteria
- Diagnosis of ALS < 6 months
- Symptoms onset < 2 years
- Patients affiliated to social security scheme
- Informed consent signed by the patient
Exclusion Criteria:
- 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
- Dermatological diseases of the fibroblast
- Skin cancer
- Protection measure for guardianship or curatorship
Control group selection criteria:
Inclusion Criteria:
- Age ≥ 18 years and ≥ 75 years
- No neuronal disease
- Patients affiliated to social security scheme
- Informed consent signed by the patient
Exclusion Criteria:
- Pregnant or breastfeeding women
- Contraindication to biopsy
- Treatment with oral or injectable anticoagulants, antiplatelet (except aspirin)
- Unbalanced Diabetes
- Systemic corticosteroid treatment
- Dermatological diseases of the fibroblast
- Skin cancer
- Protection measure for guardianship or curatorship

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984708
Contact: Hélène BLASCO, MD-PhD | 02.34.37.89.11 ext +33 | helene.blasco@univ-tours.fr |
France | |
Neurology Department, University Hospital, Limoges | Recruiting |
Limoges, France, 87042 | |
Contact: Philippe COURATIER, MD-PhD | |
Principal Investigator: Philippe COURATIER, MD-PhD | |
Neurology Department, University Hospitla, Tours | Recruiting |
Tours, France, 37044 | |
Contact: Philippe CORCIA, MD-PhD | |
Principal Investigator: Philippe CORCIA, MD-PhD |
Study Director: | Hélène BLASCO, MD-PhD | University Hospital, Tours |
Responsible Party: | University Hospital, Tours |
ClinicalTrials.gov Identifier: | NCT03984708 |
Other Study ID Numbers: |
DR180135 2019-A00649-48 ( Other Identifier: IdRCB ) |
First Posted: | June 13, 2019 Key Record Dates |
Last Update Posted: | September 30, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Amyotrophic Lateral Sclerosis Metabolomics Transcriptomics Biomarkers Fibroblast |
Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases |
Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |