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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02424669
Other study ID # 2014-19
Secondary ID RCAPHM15_0132
Status Recruiting
Phase N/A
First received April 20, 2015
Last updated November 16, 2015
Start date May 2015
Est. completion date November 2018

Study information

Verified date November 2015
Source Assistance Publique Hopitaux De Marseille
Contact Joelle Micallef
Email joelle.micallef@ap-hm.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

Amyotrophic Lateral Sclerosis (ALS) is the most common motor neuron diseases. It is considered as a rare disease with a prevalence of about 8 per 100,000 persons. Initiating in mid-life by progressive paralysis, it evolves rapidly into a generalized muscle wasting that leads irrevocably to death within 2 or 5 years of clinical onset.

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date November 2018
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

Group 1 and Group 2:

- 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:

- Familial form of ALS

- 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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
ALS Functional rating Scale-revised (ALS FRS-R)

slow vital capacity

Blood sample

Cerebrospinal Fluid (CSF) sample


Locations

Country Name City State
France Assistance Publique Hôpitaux de Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary ALS Functional rating Scale-revised (ALS FRS-R) score 12 months
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