NCT02383550

Brief Summary

This study is designed to demonstrate that Tysabri is effective in maintaining cognition in MS patients after 5 or more years of continuous treatment. During a second period of 36 months, the extension study will assess the evolution of cognitive function in Tysabri treated MS patients using the Symbol Digit Modalities Test (SDMT) and a CogState battery of tests.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2014

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

December 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

2.7 years

First QC Date

March 4, 2015

Last Update Submit

November 1, 2017

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisCognition

Outcome Measures

Primary Outcomes (2)

  • SDMT

    Cognitive assessment

    3 years

  • Cogstate Battery

    Cognitive assessment

    3 years

Interventions

Observational Cognitive assessmentsOTHER

Observational

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 who have completed the original study and are willing to continue into the extension.

You may not qualify if:

  • Patients with cognitive decline from causes other than MS (i.e., PML, stroke, sleep apnea, neurodegenerative disorders, brain tumors).

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

  • Francois 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

March 4, 2015

First Posted

March 9, 2015

Study Start

December 1, 2014

Primary Completion

August 30, 2017

Study Completion

August 30, 2017

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

CA(1)