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

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ClinicalTrials.gov Identifier: NCT02424669
Recruitment Status : Unknown
Verified November 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : April 23, 2015
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief 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.


Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis (ALS) Other: ALS Functional rating Scale-revised (ALS FRS-R) Other: slow vital capacity Other: Blood sample Other: Cerebrospinal Fluid (CSF) sample Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Neuroinflammation in Amyotrophic Lateral Sclerosis - Mechanisms and Therapeutic Perspectives: a Translational Pilot Study Among ALS Patients
Study Start Date : May 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2018


Arm Intervention/treatment
Experimental: recently diagnosed ALS patients Other: ALS Functional rating Scale-revised (ALS FRS-R)
Other: slow vital capacity
Other: Blood sample
Other: Cerebrospinal Fluid (CSF) sample
Experimental: not recently diagnosed ALS patients Other: ALS Functional rating Scale-revised (ALS FRS-R)
Other: slow vital capacity
Other: Blood sample
Other: Cerebrospinal Fluid (CSF) sample
Active Comparator: patients with peripheral neuropathy, recently diagnosed Other: Blood sample



Primary Outcome Measures :
  1. ALS Functional rating Scale-revised (ALS FRS-R) score [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02424669


Contacts
Contact: Joelle Micallef joelle.micallef@ap-hm.fr

Locations
France
Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13005
Contact: Joelle Micallef       joelle.micallef@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: Urielle Desalbres Assistance Publique Hôpitaux de Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02424669     History of Changes
Other Study ID Numbers: 2014-19
RCAPHM15_0132 ( Registry Identifier: Assistance Publique Hôpitaux Marseille )
First Posted: April 23, 2015    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases