Evaluation of Metabolomic Analysis in Early Diagnosis of ALS

ALS Clinical Trial

— METABALS  

Official title:

Evaluation of Metabolomic Analysis in Early Diagnosis of ALS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01962311
• Other study ID #: PHRN11-CA-METABALS
• Secondary ID: 2012-A00145-38
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: February 2018

Study information

• Verified date: July 2019
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project is expected to answer the question of interest assays of metabolites in the CSF as a tool for early diagnosis and should show whether it is possible or not to use such markers in the blood or urine. These studies should also help shed light on the pathophysiological original early clinical disease. While ALS appears to be more a clinical syndrome that pathophysiological entity unique metabolic abnormalities identified could help identify mechanisms disrupted in which therapeutic interventions will be possible.

Description:

A blood test that would allow the diagnosis

1. to reduce the time between the first signs and diagnosis in ALS patients for therapeutic treatment earlier and

2. to exclude rapidly non ALS in their avoiding unnecessary investigations and anxiety of being infected with a terrible prognosis disease. It is currently accepted that neurodegenerative diseases such as ALS begin before the first clinical signs and the patient could benefit from a more efficient care if it was early.

Conduct a prospective study with 400 patients.

The secondary objectives are:

1. attempt to improve the predictive power of markers assays by adding new parameters

2. to check whether the assayed molecules in other environments more accessible (blood, urine) would provide equivalent diagnostic power of those assayed in the CSF

3. identify metabolic pathways disrupted early that could be related to the pathogenesis of neurodegeneration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: February 2018
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• age 30-80

• Consent signed

• affiliation to a social security organism

Exclusion Criteria:

• Patients treated with RILUZOLE

• Enrollment in an other study

Related Conditions & MeSH terms

• ALS

Intervention

Procedure:
• lumbar puncture
lumbar puncture at enrollment in study

Locations

Country	Name	City	State
France	Pôle Neurosciences et Spécialités ,Service de Neurologie,CHU d'Angers	Angers
France	Service de Neurologie et Pathologie du Mouvement Clinique de Neurologie, Pôle des Neurosciences et de l'Appareil Locomoteur INSERM U 837	Lille
France	Centre de Recherche de l'Institut du Cerveau et de la moëlle UPMC Paris 6,Département des Maladies du Système Nerveux	Paris
France	Service de neurologie, CHU La Milétrie, POITIERS, Faculté de Médecine	Poitiers
France	University Hospital	Strasbourg
France	CHRU -TOURS-Service de Neurologie	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic markers studied are metabolites of cerebrospinal fluid, blood and urine measured by three complementary analytical methods	diagnostic criteria Diagnostic markers studied are metabolites of cerebrospinal fluid, blood and urine measured by three complementary analytical methods: GC / MS, LC / MSMS and proton NMR spectroscopy. These metabolites, the number of one hundred, can be grouped into four main groups: molecules of metabolism of carbohydrates, lipids, proteins, steroids	2 years