Multiple SclerosisCONTROLNCT01804660
Longitudinal Therapeutically Non-interventional Study of MSRV-Env Burden in Normal Population
An observational study of Multiple Sclerosis, run by GeNeuro Innovation SAS at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- No study treatments administered
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Blood donors coming for regular blood draw in the center of transfusion.
Who may be able to join
- Signature of an informed consent;
- Male or female between 18 and 60 years of age.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site
Etablissement Français du Sang Rhône Alpes - 1 route de Taninges
Annemasse, 74100
About this study
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
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.
- Conditions
- Multiple Sclerosis
- Being tested
- No study treatments administered
- Keywords
- Multiple Sclerosis (MS), Multiple Sclerosis associated RetroVirus (MSRV), MSRV envelop protein (MSRV-Env), Temelimab
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No study treatments administeredOther
| Study group | Role | What they receive |
|---|---|---|
| 25 healthy volunteers | No study treatments administered Receives: Other: No study treatments administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Inflammatory markers and reverse transcriptase activity in blood.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startOct 2012
- Primary completionNov 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- GeNeuro Innovation SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804660
- Sponsor's protocol ID
- GN-E-003
- Acronym
- CONTROL
- Status last verified
- Feb 2018
- First submitted
- 4 Mar 2013
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01804660
- Acronym / sponsor ID
- CONTROL / GN-E-003
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis (MS), Multiple Sclerosis associated RetroVirus (MSRV), MSRV envelop protein (MSRV-Env), Temelimab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- GeNeuro Innovation SASIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 25 healthy volunteers | – | Other: No study treatments administeredNo study treatments administered |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Blood donors coming for regular blood draw in the center of transfusion.
Key inclusion criteria (2 listed)
- Signature of an informed consent;
- Male or female between 18 and 60 years of age.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No study treatments administered | Other | 25 healthy volunteers |
Primary outcome
Establish a control value for the levels of MSRV expression in the normal population over time
Time frame: 1 year
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 secondary outcome
Inflammatory markers and reverse transcriptase activity in blood.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by GeNeuro Innovation SAS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish a control value for the levels of MSRV expression in the normal population over time (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.