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
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.
- 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