NCT03984708Completed
New Therapeutic Strategy in ALS Based on Metabolic Status and Associated Metabolic Pathways.
Source: ClinicalTrials.gov · Last updated 30 Dec 2025
Brief summary (registry, in English)
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that affects central and peripheral motor neurons. None of the clinical trials conducted have been clearly successful and the disease remains incurable, putting patients' vital prognosis at risk in the medium term. An alteration of the basal metabolism leading to hypermetabolism has been described in several articles in the literature. The causes of this hypermetabolism and the precise exploration of the metabolic pathways involved are still poorly understood. The fibroblasts of ALS patients may be the site of some metabolic disturbances in this disease with a hypothetical specific basal metabolic profile. These cells are adapted to different metabolic explorations such as omnic approaches. Superficial skin biopsy followed by fibroblast culture can provide a considerable biobank. This cellular richness will allow us, in ALS patients and their controls, to perform metabolomic and lipidomic approaches, as well as the quantification transcriptomic approach."
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 9 (actual)
- First submitted
- 4 Jun 2019
- Start date
- 27 Jan 2020
- Primary completion date
- 10 Jan 2023
- Lead sponsor
- University Hospital, Tours
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT03984708
What you commit to
- Study type: Interventional
- Participants enrolled: 9
- From 27 Jan 2020 to the primary completion date, 10 Jan 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with oral or injectable anticoagulants, antiplatelet (except aspirin)
- Systemic corticosteroid treatment
- Treatment with oral or injectable anticoagulants, antiplatelet (except aspirin)
- Systemic corticosteroid treatment
Other illness
- Unbalanced Diabetes
- Dermatological diseases of the fibroblast
- Skin cancer
- Unbalanced Diabetes
- Dermatological diseases of the fibroblast
- Skin cancer
Other
- Pregnant or breastfeeding women
- Contraindication to biopsy
- Contraindication to local anesthesia
- Protection measure for guardianship or curatorship
- Control group selection criteria:
- Pregnant or breastfeeding women
- Contraindication to biopsy
- Protection measure for guardianship or curatorship
Who the study is looking for
- 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
- Age ≥ 18 years and ≥ 75 years
- No neuronal disease
- Patients affiliated to social security scheme
- Informed consent signed by the patient
Criteria the registry did not label
- Case group selection criteria:
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neurology Department, University Hospital, Limoges Coordinator of this site? Confirm its status | Limoges | France | Unknown status |
| Neurology Department, University Hospitla, Tours Coordinator of this site? Confirm its status | Tours | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.