Trials / Completed
CompletedNCT01804647
Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Patients With Multiple Sclerosis Disease
A One Year Longitudinal Therapeutically Non-Interventional Study of MSRV-Env Burden in Multiple Sclerosis Patients (RRMS - SPMS - PPMS - CIS) as Assessed by PCR and ELISA in Blood
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 58 (actual)
- Sponsor
- GeNeuro Innovation SAS · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
This study intends to explore evolution of MSRV expression by analyzing the levels of MSRV transcripts in blood, as well as the levels of the MSRV-Env protein in serum of MS patients. The study will be conducted over one year in four cohorts of patients with different forms of MS (remitting-relapsing MS i.e. RRMS, primary-progressive MS i.e. PPMS and secondary-progressive MS i.e. SPMS) and in clinically isolated syndrome (CIS) patients who have suffered a single clinical event but do not comply with diagnosis criteria for definite MS. The MSRV RNA and MSRV-Env protein levels will be correlated with the clinical evolution of patients and with the reverse transcriptase activity, inflammatory markers assessed by cytokines levels. A control group of healthy subjects will be included (the study, GN-E-003, is performed in parallel and is part of another dedicated protocol).
Conditions
- Multiple Sclerosis (MS)
- Relapsing-Remitting MS
- Primary Progressive MS
- Secondary Progressive MS
- Clinically Isolated Syndrome (CIS)
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No study treatments administered - blood draws only |
Timeline
- Start date
- 2012-11-01
- Primary completion
- 2015-02-01
- Completion
- 2015-02-01
- First posted
- 2013-03-05
- Last updated
- 2020-10-20
Locations
4 sites across 3 countries: France, Spain, Switzerland
Source: ClinicalTrials.gov record NCT01804647. Inclusion in this directory is not an endorsement.