Evaluation of Cognitive Disability and Quality of Life of Patients Suffering From Multiple Scleroses and Treat With Immunosuppressant

CompletedNot a drug-phase studyRelapsing MSNCT01392872

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Neuropsychological assessment

What it measured

Main measures

  • Evolution of the quality of life of patients diagnosed with relapsing MS and starting a treatment with immunosuppressant

    on a 36 months period

    Quality of life (reported by participants)

Other measures (11)

  • Analysis of variance for repeated measurement

    15 to 30 days before the beginning of treatment, after 36 months

  • Selective Reminding Test (SRT)

    15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months

  • Delayed recall of SRT

    15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months

  • Visuo-spatial span

    15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months

  • Digit span

    15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months

  • Reverse span

    15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months

  • Stroop test

    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

    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

    15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months

    Disability progressionWalking and mobility
  • Disability (EDSS) : Analysis of variance for repeated measurement

    15 to 30 days before the beginning of treatment, 1st day of treatment, after 6,12,18 and 36 months

    Disability progression

Who could take part

Relapsing MS · 18 and over

Show the full criteria

Inclusion criteria

* 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)

Exclusion criteria

* Secondary Progressive MS * Patient having an attack * Patient having experienced en MS relapse or recovered systemic corticosteroid in the previous 1 month * Depressive patient

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Nov 2009

    2. Main results due

      Jan 2016

    3. Finished

      Jan 2016

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