Amyotrophic Lateral SclerosisFG-CoALSNCT06147843
French-German Cohort Study to Determine Factors Associated With Weight Loss in Amyotrophic Lateral Sclerosis
A study testing Blood sample in people with Amyotrophic Lateral Sclerosis, run by University Hospital, Limoges at 9 sites in 2 countries.
Trial summary
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease. Studies have shown the importance of weight loss at the time of diagnosis and during the progression of the disease. However, the pathophysiological mechanisms behind weight loss remain unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 17 Sep 2024to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Incident cases included at the time of diagnosis with a definite, probable, probable laboratory-supported, or possible ALS according to El Escorial revised criteria and Gold Coast criteria for early diagnosis.
- Incident ALS cases identified and followed-up in the participant ALS \& Other Motor Neuron Diseases Referral Centres: seven in France and two in Germany.
- Patients who signed the informed consent form.
- Adults aged >18 years old
Who cannot join
- Inability to understand the requirements of the protocol.
- Cognitive inability to sign and comprehend the informed consent form.
- Patients who will not accept Riluzole therapy during their follow-up.
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Andrea ERAZO ALEMAN, Dr contact
9 sites in 2 countries
France7 sites, 7 recruiting
- Recruiting
CHU de Lille
Lille, 59037
Veronique DANEL-BRUNAUD, Medicine Doctor, +33 3 20 44 67 52, veronique.danel@chu-lille.fr
- Recruiting
Limoges University Hospital
Limoges, 87042
Philippe COURATIER, Professor, 05 55 05 15 69, philippe.couratier@chu-limoges.fr
sandra JUGE, Dr, 05 55 05 64 14, sandra.juge@chu-limoges.fr
- Recruiting
Hôpital de la Timone
Marseille, 13005
Shahram ATTARIAN, Professor, +33 04 91 38 65 79, sharam.attarian@ap-hm.fr
- Recruiting
Hôpital Gui Chauliac
Montpellier, 34295
Elisa De La Cruz, Medicine Doctor, +33 4 67 33 76 23, e-delacruz@chu-montpellier.fr
- Recruiting
CHU de Nice
Nice, 06001
Marie-Hélène SORIANI SORIANI, Medicine Doctor, +33 4 92 03 55 04, soriani.mh@chu-nice.fr
- Recruiting
Hôpital de la Pitié Salpêtrière
Paris, 75013
Gaëlle BRUNETEAU, Professor, +33 1 42 16 24 72, gaelle.bruneteau@aphp.fr
- Recruiting
CHU de Tours
Tours, 37044
Philippe CORCIA, Professor, +33 2 47 47 37 24, philippe.corcia@univ--tours.fr
Germany2 sites, 2 recruiting
- Not yet recruiting
Klinik für Medizinische Hochschule Hannover Carl-Neuberg-Str. 1
Hanover, Allemagne, 30625
Susanne PETRI, Pr, 49 (0)511 532 3122, Susanne.Petri@diakovere.de
- Not yet recruiting
Klinik für Neurologie, Universitäts- und Rehabilitationskliniken Ulm (RKU
Ulm, Allemagne, 89081
Maximilian WIESENFARTH, Pr, 49 (0)731 177 1201, maximilian.wiesenfarth@rku.de
About this study
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease. Studies have shown the importance of weight loss at the time of diagnosis and during the progression of the disease. However, the pathophysiological mechanisms behind weight loss remain unknown. Identifying these mechanisms could make it possible to propose an effective therapeutic strategy against weight loss for ALS patients, which could improve their survival and quality of life. In this context, the investigators are proposing an innovative multidisciplinary project aimed at structuring a large Franco-German cohort to identify the markers associated with weight loss in ALS.
Participants will undergo high quality standard care for ALS patients. In addition, participants will be asked to respond different questionnaires and blood samples will be taken for analysis to identify biological markers.
Read the detailed description
ALS is the most frequent adult onset motor neuron disease and is highly variable in terms of clinical features, genetics, and neuropathology. A large body of evidence has demonstrated the importance of weight loss at the time of diagnosis and during disease progression. Weight loss affects between one and two-thirds of patients and is adversely associated with survival. High caloric nutrition was able to slow weight loss and prolong survival in fast progressing ALS patients. Pathophysiological mechanisms underlying weight loss remain unknown because high-quality cohort data collecting clinical features, genetics, omics, and imaging related to the metabolic and disease status of patients are lacking. The investigators hypothesize that weight loss in ALS patients is biologically driven through specific pathways. The investigators propose an innovative and ambitious multidisciplinary project to structure a large French-German cohort to identify markers associated with weight loss. The investigators aim at identifying the biological correlates of weight loss to disentangle the mechanistic basis of this critical symptom and to determine clinical and biological profiles along with their impact on disease progression and survival.
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- Blood sample
- Keywords
- Amyotrophic lateral sclerosis, Weight Loss, Genetics, Nutrition, Prognosis, Metabolomics, Inflammation
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Weight Loss, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Blood sample will be taken to identify Genomic, metabolomic, metabolic, neurofilaments, and inflammation markers associated to weight loss
| Study group | Role | What they receive |
|---|---|---|
| ALL participants | Other | ALS patients will be stratified in 4 groups according to the weight loss percentage: a) no weight loss; b) <5% of weight loss; c) 5-10% of weight loss; d) >10% of weight loss.
In order to identify the genomic, metabolomic, metabolic, neurofilaments, and inflammation markers associated to weight loss. Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Survival evaluated in month since diagnosis
Measured: every 6 month until 18 months of follow up
Secondary outcomes (1)
Disease progression (ALSFRS-R slope)
The ALSFRS-R is a validated rating instrument for monitoring the progression of disability in patients with amyotrophic lateral sclerosis (ALS)
Measured: every 6 month until 18 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start17 Sep 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France, Centre de Recherche en biomédecine de Strasbourg INSERM UMR-S1118, Paris Brain Institute (ICM), Institut National de la Santé et de la Recherche Médical - délégation Grand Ouest INSERM U1253, Klinik für Neurologie, Universitäts- und Rehabilitationskliniken Ulm (RKU), Centre de Données Cliniques et de Recherche CDCR, UMR Inserm U1253-IBRain-Neurogénétique et Physiopathologie Neuronale, France Cohorte
- Responsible party
- Sponsor
- Investigators
- Philippe COURATIER, Professor, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06147843
- Sponsor's protocol ID
- 87RI21_0053
- Acronym
- FG-CoALS
- Status last verified
- Jun 2026
- First submitted
- 12 Jul 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The FG-CoALS project is part of the 11 cohorts of rare diseases of the National Research Agency (ANR) in France. The ANR has entrusted "France Cohortes" with the task of supporting 11 projects on rare diseases. With the implementation of a FAIR approach right from the data collection phase, the national research infrastructure dedicated to "France cohortes" will contribute to the management, dissemination and re-use of data, while guaranteeing the strict protection of the data.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French-German Cohort Study to Determine Factors Associated With Weight Loss in Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT06147843
- Acronym / sponsor ID
- FG-CoALS / 87RI21_0053
- Conditions
- Amyotrophic Lateral Sclerosis
- Keywords
- Amyotrophic lateral sclerosis, Weight Loss, Genetics, Nutrition, Prognosis, Metabolomics, Inflammation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Collaborators
- National Research Agency, France, Centre de Recherche en biomédecine de Strasbourg INSERM UMR-S1118, Paris Brain Institute (ICM), Institut National de la Santé et de la Recherche Médical - délégation Grand Ouest INSERM U1253, Klinik für Neurologie, Universitäts- und Rehabilitationskliniken Ulm (RKU), Centre de Données Cliniques et de Recherche CDCR, UMR Inserm U1253-IBRain-Neurogénétique et Physiopathologie Neuronale, France Cohorte
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 28 Nov 2023 (actual)
- 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.
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease. Studies have shown the importance of weight loss at the time of diagnosis and during the progression of the disease. However, the pathophysiological mechanisms behind weight loss remain unknown. Identifying these mechanisms could make it possible to propose an effective therapeutic strategy against weight loss for ALS patients, which could improve their survival and quality of life. In this context, the investigators are proposing an innovative multidisciplinary project aimed at structuring a large Franco-German cohort to identify the markers associated with weight loss in ALS.
Participants will undergo high quality standard care for ALS patients. In addition, participants will be asked to respond different questionnaires and blood samples will be taken for analysis to identify biological markers.
Detailed description
ALS is the most frequent adult onset motor neuron disease and is highly variable in terms of clinical features, genetics, and neuropathology. A large body of evidence has demonstrated the importance of weight loss at the time of diagnosis and during disease progression. Weight loss affects between one and two-thirds of patients and is adversely associated with survival. High caloric nutrition was able to slow weight loss and prolong survival in fast progressing ALS patients. Pathophysiological mechanisms underlying weight loss remain unknown because high-quality cohort data collecting clinical features, genetics, omics, and imaging related to the metabolic and disease status of patients are lacking. The investigators hypothesize that weight loss in ALS patients is biologically driven through specific pathways. The investigators propose an innovative and ambitious multidisciplinary project to structure a large French-German cohort to identify markers associated with weight loss. The investigators aim at identifying the biological correlates of weight loss to disentangle the mechanistic basis of this critical symptom and to determine clinical and biological profiles along with their impact on disease progression and survival.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALL participants | Other | Other: Blood sampleALS patients will be stratified in 4 groups according to the weight loss percentage: a) no weight loss; b) <5% of weight loss; c) 5-10% of weight loss; d) >10% of weight loss. In order to identify the genomic, metabolomic, metabolic, neurofilaments, and inflammation markers associated to weight loss. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Incident cases included at the time of diagnosis with a definite, probable, probable laboratory-supported, or possible ALS according to El Escorial revised criteria and Gold Coast criteria for early diagnosis.
- Incident ALS cases identified and followed-up in the participant ALS \& Other Motor Neuron Diseases Referral Centres: seven in France and two in Germany.
- Patients who signed the informed consent form.
- Adults aged >18 years old
Key exclusion criteria (3 listed)
- Inability to understand the requirements of the protocol.
- Cognitive inability to sign and comprehend the informed consent form.
- Patients who will not accept Riluzole therapy during their follow-up.
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 |
|---|---|---|
| Blood sampleBlood sample will be taken to identify Genomic, metabolomic, metabolic, neurofilaments, and inflammation markers associated to weight loss | Other | ALL participants |
Primary outcome
Survival
Time frame: every 6 month until 18 months of follow up
Survival evaluated in month since diagnosis
1 secondary outcome
Disease progression (ALSFRS-R slope)
Time frame: every 6 month until 18 months of follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: Yes. The FG-CoALS project is part of the 11 cohorts of rare diseases of the National Research Agency (ANR) in France. The ANR has entrusted "France Cohortes" with the task of supporting 11 projects on rare diseases. With the implementation of a FAIR approach right from the data collection phase, the national research infrastructure dedicated to "France cohortes" will contribute to the management, dissemination and re-use of data, while guaranteeing the strict protection of the data.
Related trials for Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
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.
Andrea ERAZO ALEMAN, Dr contact
Philippe COURATIER, Professor principal investigator
University Hospital, Limoges
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Amyotrophic Lateral Sclerosis, run by University Hospital, Limoges at 9 sites in 2 countries.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France, Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe COURATIER, Pr (05 55 05 15 69, philippe.couratier@chu-limoges.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: every 6 month until 18 months of follow up). 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 6 Aug 2026.