Neuroinflammation in Amyotrophic Lateral Sclerosis - Mechanisms and Therapeutic Perspectives: a Translational Pilot Study Among ALS Patients

Amyotrophic Lateral Sclerosis (ALS) Clinical Trial

Official title:

Neuroinflammation in Amyotrophic Lateral Sclerosis - Mechanisms and Therapeutic Perspectives: a Translational Pilot Study Among ALS Patients

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

• Amyotrophic Lateral Sclerosis
• Amyotrophic Lateral Sclerosis (ALS)
• Motor Neuron Disease
• Sclerosis

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