Multiple Sclerosis, Relapsing-RemittingCoQualSEPNCT01392872
Cognitive Disability and Quality of Life of Patients Suffering From Multiple Sclerosis and Treatment With Immunosuppressant
A study testing Neuropsychological assessment in people with Multiple Sclerosis, Relapsing-Remitting, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Multiple Sclerosis is the first cause of neurological handicap in France. The importance of cognitive disabilities, their evaluation and their impact on patients' life have only been comprehended recently. Immunosuppressants represent new treatments in Multiple Sclerosis (MS) but imply a lot of constraints. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- Neuropsychological assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2009to Jan 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Relapsing MS since at least 6 months and less than 10 years
- Neurological state stable since at least 1 month
- Moderate Handicap (EDSS ≤ 5,5)
Who cannot join
- Secondary Progressive MS
- Patient having an attack
- Patient having experienced en MS relapse or recovered systemic corticosteroid in the previous 1 month
- Depressive patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Cognitive Disability and Quality of Life of Patients Suffering From Multiple Scleroses and Treat With Immunosuppressant
Multiple Sclerosis is the first cause of neurological handicap in France. The importance of cognitive disabilities, their evaluation and their impact on patients' life have only been comprehended recently. Immunosuppressants represent new treatments in Multiple Sclerosis (MS) but imply a lot of constraints. This study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period.
Read the detailed description
Multiple Sclerosis is the first cause of neurological handicap in France. The importance of cognitive disabilities, their evaluation and their impact on patients' life have only been comprehended recently. Immunosuppressants represent new treatments in MS but imply a lot of constraints. This study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- Neuropsychological assessment
- Keywords
- Immunosuppressant, Quality of life, Cognitive function, Relapsing Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological assessmentOther
This study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period.
| Study group | Role | What they receive |
|---|---|---|
| sclerosis | Other | Not described Receives: Other: Neuropsychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the quality of life of patients diagnosed with relapsing MS and starting a treatment with immunosuppressant
Measured: on a 36 months period
Secondary outcomes (11)
Analysis of variance for repeated measurement
Measured: 15 to 30 days before the beginning of treatment, after 36 months
Selective Reminding Test (SRT)
Measured: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
Delayed recall of SRT
Measured: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
Visuo-spatial span
Measured: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
Digit span
Measured: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
Reverse span
Measured: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
Stroop test
Measured: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
• Tiredness (EMIF SEP scale): Analysis of variance for repeated measurement
Measured: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months
• Physical function (9HPT, 8 meter walk) : Analysis of variance for repeated measurement
Measured: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months
Disability (EDSS) : Analysis of variance for repeated measurement
Measured: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months
• Psychological disorder (Beck depression inventory, COVI scale, Depressive scale) : Analysis of variance for repeated measurement
Measured: 15 to 30 days before the beginning of treatment, 1st day of the treatment, after 6,12,18 and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startNov 2009
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bordeaux, University Hospital, Caen, University Hospital, Marseille, Dr Remy MORELLO - CHU de Caen
- Responsible party
- Sponsor
- Investigators
- Pierre CLAVELOU, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392872
- Sponsor's protocol ID
- CHU-0094
- Acronym
- CoQualSEP
- Status last verified
- Aug 2026
- First submitted
- 5 May 2011
- Last updated
- 5 Aug 2026
- Results posted
- No
Publications
Planche V, Moisset X, Morello R, Dumont E, Gibelin M, Charre-Morin J, Saubusse A, Mondou A, Reuter F, Defer G, Pelletier J, Brochet B, Clavelou P. Improvement of quality of life and its relationship with neuropsychiatric outcomes in patients with multiple sclerosis starting treatment with natalizumab: A 3-year follow-up multicentric study. J Neurol Sci. 2017 Nov 15;382:148-154. doi: 10.1016/j.jns.2017.10.008. Epub 2017 Oct 6.
PubMed 29111011
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cognitive Disability and Quality of Life of Patients Suffering From Multiple Scleroses and Treat With Immunosuppressant
- ClinicalTrials.gov ID
- NCT01392872
- Acronym / sponsor ID
- CoQualSEP / CHU-0094
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Keywords
- Immunosuppressant, Quality of life, Cognitive function, Relapsing Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- University Hospital, Bordeaux, University Hospital, Caen, University Hospital, Marseille, Dr Remy MORELLO - CHU de Caen
- Study start
- Nov 2009
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 13 Jul 2011 (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.
Multiple Sclerosis is the first cause of neurological handicap in France. The importance of cognitive disabilities, their evaluation and their impact on patients' life have only been comprehended recently. Immunosuppressants represent new treatments in Multiple Sclerosis (MS) but imply a lot of constraints. This study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period.
Detailed description
Multiple Sclerosis is the first cause of neurological handicap in France. The importance of cognitive disabilities, their evaluation and their impact on patients' life have only been comprehended recently. Immunosuppressants represent new treatments in MS but imply a lot of constraints. This study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sclerosis | Other | Other: Neuropsychological assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Relapsing MS since at least 6 months and less than 10 years
- Neurological state stable since at least 1 month
- Moderate Handicap (EDSS ≤ 5,5)
Key exclusion criteria (4 listed)
- Secondary Progressive MS
- Patient having an attack
- Patient having experienced en MS relapse or recovered systemic corticosteroid in the previous 1 month
- Depressive patient
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 |
|---|---|---|
| Neuropsychological assessmentThis study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period. | Other | sclerosis |
Primary outcome
Evolution of the quality of life of patients diagnosed with relapsing MS and starting a treatment with immunosuppressant
Time frame: on a 36 months period
11 secondary outcomes
Analysis of variance for repeated measurement
Time frame: 15 to 30 days before the beginning of treatment, after 36 months
Selective Reminding Test (SRT)
Time frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
Delayed recall of SRT
Time frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
Visuo-spatial span
Time frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
Digit span
Time frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
Reverse span
Time frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
Stroop test
Time frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months
• Tiredness (EMIF SEP scale): Analysis of variance for repeated measurement
Time frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months
• Physical function (9HPT, 8 meter walk) : Analysis of variance for repeated measurement
Time frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months
Disability (EDSS) : Analysis of variance for repeated measurement
Time frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months
• Psychological disorder (Beck depression inventory, COVI scale, Depressive scale) : Analysis of variance for repeated measurement
Time frame: 15 to 30 days before the beginning of treatment, 1st day of the treatment, after 6,12,18 and 36 months
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 5 Aug 2026.
- Results publication: PubMed 29111011Planche V, Moisset X, Morello R, Dumont E, Gibelin M, Charre-Morin J, Saubusse A, Mondou A, Reuter F, Defer G, Pelletier J, Brochet B, Clavelou P. Improvement of quality of life and its relationship with neuropsychiatric outcomes in patients with multiple sclerosis starting treatment with natalizumab: A 3-year follow-up multicentric study. J Neurol Sci. 2017 Nov 15;382:148-154. doi: 10.1016/j.jns.2017.10.008. Epub 2017 Oct 6.
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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.
Pierre CLAVELOU principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological assessment in people with Multiple Sclerosis, Relapsing-Remitting, run by University Hospital, Clermont-Ferrand 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 3 inclusion and 4 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 5 Aug 2026. 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?
Evolution of the quality of life of patients diagnosed with relapsing MS and starting a treatment with immunosuppressant (time frame: on a 36 months period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01392872, which also lists 1 linked publication.
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 5 Aug 2026.