NCT01658384

Brief Summary

This study is designed to evaluate the effect of Tysabri on cognition in multiple sclerosis (MS) patients. During a period of 24 months, the study will assess the evolution of cognitive function in Tysabri treated MS patients using the Symbol Digit Modalities Test (SDMT) and the CogState battery of tests.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

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

September 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2011

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

3.4 years

First QC Date

November 10, 2011

Last Update Submit

March 4, 2019

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • SDMT CogState battery

    Monthly cognitive assessments

    2 years

Study Arms (1)

cognitive evolution, observational,MS

multiple sclerosis tysabri treated patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with multiple sclerosis who are receiving Tysabri per indication.

You may qualify if:

  • Patients with multiple sclerosis who are receiving Tysabri per indication and are willing and able to give an informed consent.

You may not qualify if:

  • Patients who are depressed as per the Beck depression questionnaire at screening or at any time during the study.
  • Patients with cognitive decline from causes other than MS.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Neuro-Outaouais

Gatineau, Quebec, J9J 0A5, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • François H Jacques, MD

    Clinique Neuro-Outaouais

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2011

First Posted

August 7, 2012

Study Start

September 1, 2011

Primary Completion

February 1, 2015

Study Completion

March 1, 2015

Last Updated

March 6, 2019

Record last verified: 2019-03

Locations

CA(1)