Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Normal Population

Multiple Sclerosis Clinical Trial

— CONTROL  

Official title:

A One Year Longitudinal Therapeutically Non-Interventional Study of MSRV-Env Burden in Normal Population as Assessed by PCR and ELISA in Blood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01804660
• Other study ID #: GN-E-003
• Status: Completed
• Start date: October 2012
• Est. completion date: December 2013

Study information

• Verified date: February 2018
• Source: GeNeuro SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study intends to explore the levels of MSRV expression by analyzing the levels of MSRV transcripts in blood, as well as the levels of the MSRV-Env protein in serum in the normal population. This study is important for establishing a baseline to analyze results obtained in MS patients (another dedicated study is performed in parallel in MS patients). The study will be conducted over one year in a cohort of healthy subjects. The MSRV RNA level, MSRV-Env protein levels, reverse transcriptase activity, inflammatory markers assessed by cytokines levels will be analysed to define control levels in the normal population and their variation during one year. The data obtained in this study in healthy controls will be compared to those obtained in a parallel similar study, GN-E-002, conducted in different types of MS patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Signature of an informed consent;

• Male or female between 18 and 60 years of age.

Exclusion Criteria:

• Positive serology for hepatitis B or C or HIV;

• Acute infection at inclusion;

• Severe psychiatric disorder, neurological, inflammatory, or autoimmune disease;

• Pregnancy or breastfeeding;

• Heavy smokers i.e. more than 10 cigarettes per day;

• History of alcohol or drug abuse in the last 3 years;

• Participation in a clinical trial (within the last 3 months).

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• No study treatments administered

Locations

Country	Name	City	State
France	Etablissement Français du Sang Rhône Alpes - 1 route de Taninges	Annemasse

Sponsors (1)

Lead Sponsor	Collaborator
GeNeuro Innovation SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish a control value for the levels of MSRV expression in the normal population over time	Establish a control value for the levels of MSRV expression in the normal population over time using 3 approaches: MSRV transcripts in PBMC; MSRV transcripts in plasma; MSRV-Env protein in serum.	1 year
Secondary	Inflammatory markers and reverse transcriptase activity in blood.		1 year