NCT01658384

Completed

Cognitive Evolution in Tysabri Treated Multiple Sclerosis Pa...

Clinique Neuro-Outaouais Source

Compare

Other study identifiers

Sponsor study identifier

CNO-001

Study Type

observational

Actual enrollment (reported)

63

Locations

1 country

Sites

1

Timeline

Study Start

September 2011

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

February 2015

Actual (reported)

Study Completion

March 2015

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 63 participants
Study completion date: March 2015
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2011
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
November 10, 2011
Actual (reported)
First Posted
August 7, 2012
Actual (reported)
Primary Completion
February 2015
Actual (reported)
Study Completion
March 2015
Actual (reported)

Last Updated: March 6, 2019
Status Verified: March 2019
Last Update Submitted: 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:

Sponsors & Collaborators

Clinique Neuro-Outaouais
Otherlead
CogState Ltd.
Industrycollaborator

Study Sites (1)

Clinique Neuro-Outaouais

Gatineau, Quebec, J9J 0A5, Canada

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

Enrollment

63 participants (actual enrollment reported by the registry).

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 2011

Date type not reported

This date has not been verified as actual or estimated.

NCT01071512

Tysabri Effects on Cognition and Neurodegeneration in Multiple Sclerosis

Not ApplicableCompleted

NCT01235221

Open Label Extension Study to Evaluate the Safety and Tolerability of Oral Fampridine-Sustained Release (SR) in Canadian Participants With Multiple Sclerosis Who Participated in Acorda Extension Trials.

Phase 3Completed

NCT01118130

Pharmacogenomics of Drug Safety in Multiple Sclerosis

Completed

NCT01489748

Canadian Avonex PEN Productivity Study

Completed

NCT01611987

The Role of Exercise in Modifying Outcomes for People With Multiple Sclerosis

Not ApplicableUnknown

NCT01122056

Effect of Aerobic Exercise on Side Effects of Disease Modifying Therapy With Subcutaneous Interferon-b1b in Patients With Multiple Sclerosis

Not ApplicableCompleted

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.

Primary Completion

February 2015

Actual (reported)

Study Completion

March 2015

Actual (reported)

Last Updated

March 6, 2019

Record last verified: 2019-03

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01658384
Data provider: ClinicalTrials.gov
Source updated: 2019-03-06
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:34 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

cognitive evolution, observational,MS

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations