Neuroinflammation in Amyotrophic Lateral Sclerosis - Mechanisms and Therapeutic Perspectives: a Translational Pilot Study Among ALS Patients
NCT ID: NCT02424669
Last Updated: 2015-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2015-05-31
2018-11-30
Brief Summary
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Since there is no cure for ALS, the management of the disease is supportive and palliative. Riluzole is the only drug that has been shown to extend survival by about three months. The identification of biomarkers sensitive to the progression of the disease might enhance the diagnostic and provide new drug targets.
Dysfunction of the immune system is a pathological hallmark of ALS. Increased levels of interferon gamma (IFNgamma) were found in the serum and cerebrospinal fluid (CSF) of ALS patients. However, the cell origin as well as the pathogenic influence of this peripheral source of IFNg is unknown. Thus, IFNgamma might have a role in the pathogenic process of ALS and might be a potential biomarker of the disease.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
NONE
Study Groups
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recently diagnosed ALS patients
ALS Functional rating Scale-revised (ALS FRS-R)
slow vital capacity
Blood sample
Cerebrospinal Fluid (CSF) sample
not recently diagnosed ALS patients
ALS Functional rating Scale-revised (ALS FRS-R)
slow vital capacity
Blood sample
Cerebrospinal Fluid (CSF) sample
patients with peripheral neuropathy, recently diagnosed
Blood sample
Interventions
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ALS Functional rating Scale-revised (ALS FRS-R)
slow vital capacity
Blood sample
Cerebrospinal Fluid (CSF) sample
Eligibility Criteria
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Inclusion Criteria
* with sporadic ALS (without family history), recently diagnosed (onset of first symptoms \< 24 months) group 1, not recently diagnosed (onset of first symptoms \> 24 months) group 2
* Who meet the laboratory-supported probable, probable or definite form of ALS according to the El Escorial criteria
* Suffering from the spinal form of ALS
Group 3:
\- with an inflammatory peripheral neuropathy, or a non inflammatory peripheral neuropathy, recently diagnosed
Exclusion Criteria
* Bulbar form and respiratory onset form of ALS
* Subjects with a clinically significant history of unstable or severe cardiac, oncologic, hepatic or renal disease, or other medically significant illness.
* Subjects with significant cognitive impairment, clinical dementia, or psychiatric illness.
* Female of childbearing potential (apart of patient using adequate contraceptive measures), pregnant or breast feeding
* Suspected inability to complete the study follow-up (foreign workers, transient visitors, tourists or any others for whom follow-up evaluation is not assured)
* Participation in any other clinical study within 30 days prior to the Screening Visit
* Persons deprived of freedom by judicial or administrative decision, hospitalized without their consent or for other reasons than the research, under legal protection or unable to express their consent
18 Years
80 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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Urielle Desalbres
Role: STUDY_DIRECTOR
Assistance Publique Hôpitaux de Marseille
Locations
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Assistance Publique Hôpitaux de Marseille
Marseille, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RCAPHM15_0132
Identifier Type: REGISTRY
Identifier Source: secondary_id
2014-19
Identifier Type: -
Identifier Source: org_study_id