NCT01392872

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 13, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

6.2 years

First QC Date

May 5, 2011

Last Update Submit

July 28, 2016

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

ImmunosuppressantQuality of lifeCognitive functionRelapsing Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

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

    on a 36 months period

Secondary Outcomes (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

  • +6 more secondary outcomes

Study Arms (1)

sclerosis

OTHER
Other: Neuropsychological assessment

Interventions

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.

sclerosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • 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.

    PMID: 29111011DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Pierre CLAVELOU

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2011

First Posted

July 13, 2011

Study Start

November 1, 2009

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

July 29, 2016

Record last verified: 2016-07

Locations

FR(1)