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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was  Recruiting
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
  Purpose

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.


Condition Intervention
Multiple Sclerosis, Relapsing-Remitting
Other: Neuropsychological assessment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of Cognitive Disability and Quality of Life of Patients Suffering From Multiple Scleroses and Treat With Immunosuppressant

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: November 2009
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
sclerosis 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392872

Contacts
Contact: Patrick LACARIN 0473751195 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    0473751195    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
University Hospital, Bordeaux
University Hospital, Caen
University Hospital, Marseille
Dr Remy MORELLO – CHU de Caen
Investigators
Principal Investigator: Pierre CLAVELOU University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: Patrick LACARIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01392872     History of Changes
Other Study ID Numbers: CHU-0094
Study First Received: May 5, 2011
Last Updated: July 12, 2011
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Immunosuppressant
Quality of life
Cognitive function
Relapsing Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Immunosuppressive Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014