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Cognitive Disability and Quality of Life of Patients Suffering From Multiple Sclerosis and Treatment With Immunosuppressant (CoQualSEP)

This study is currently recruiting participants.
Verified July 2011 by University Hospital, Clermont-Ferrand
Sponsor:
Collaborators:
University Hospital, Bordeaux
University Hospital, Caen
University Hospital, Marseille
Dr Remy MORELLO – CHU de Caen
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01392872
First received: May 5, 2011
Last updated: July 12, 2011
Last verified: July 2011
History of Changes

May 5, 2011
July 12, 2011
November 2009
November 2011   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01392872 on ClinicalTrials.gov Archive Site
  • Analysis of variance for repeated measurement [ Time Frame: 15 to 30 days before the beginning of treatment, after 36 months ] [ Designated as safety issue: No ]
  • Selective Reminding Test (SRT) [ Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months ] [ Designated as safety issue: No ]
  • Delayed recall of SRT [ Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months ] [ Designated as safety issue: No ]
  • Visuo-spatial span [ Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months ] [ Designated as safety issue: No ]
  • Digit span [ Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months ] [ Designated as safety issue: No ]
  • Reverse span [ Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months ] [ Designated as safety issue: No ]
  • Stroop test [ Time Frame: 15 to 30 days before the beginning of treatment, 1st day of treatment, after 18 and 36 months ] [ Designated as safety issue: No ]
  • • 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 ] [ Designated as safety issue: No ]
  • • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cognitive Disability and Quality of Life of Patients Suffering From Multiple Sclerosis and Treatment With Immunosuppressant
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.

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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Multiple Sclerosis, Relapsing-Remitting
Other: Neuropsychological assessment
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.
sclerosis
Intervention: Other: Neuropsychological assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Patrick LACARIN 0473751195 placarin@chu-clermontferrand.fr
France
 
NCT01392872
CHU-0094
Not Provided
Patrick LACARIN, CHU Clermont-Ferrand
University Hospital, Clermont-Ferrand
  • University Hospital, Bordeaux
  • University Hospital, Caen
  • University Hospital, Marseille
  • Dr Remy MORELLO – CHU de Caen
Principal Investigator: Pierre CLAVELOU University Hospital, Clermont-Ferrand
University Hospital, Clermont-Ferrand
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP