Multiple SclerosisCogMS-ExtNCT02383550
Cognitive Evolution in Tysabri Treated Multiple Sclerosis Patients - A Three Year Extension
An observational study of Multiple Sclerosis, run by Clinique Neuro-Outaouais at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Observational Cognitive assessments
- How many people
- 46 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2014to 30 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with multiple sclerosis who are receiving Tysabri per indication.
Who may be able to join
- Patients who have completed the original study and are willing to continue into the extension.
Who cannot join
- Patients with cognitive decline from causes other than MS (i.e., PML, stroke, sleep apnea, neurodegenerative disorders, brain tumors).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Tysabri reduces the relapse frequency, slows progression and preserves cognitive function as compared to placebo as per the AFFIRM trial. The benefit on relapse rate and progression appears to be sustained in longer-term studies such as STRATA. In clinical practice however despite a stable EDSS patients often complain of cognitive deterioration.
The investigators' preliminary results from the first pilot study have shown that cognition in Tysabri treated MS patients for two or more years, as measured by the SDMT or Cogstate battery is maintained, including the ability to learn. The investigators' final data will be presented at the American Academy of Neurology (AAN) in 2015.
The Symbol Digit Modalities Test (SDMT) is a sensitive and validated test of cognition in MS. CogState offers a standardized battery of cognitive tests frequently used in clinical research in the fields of dementia and Parkinson's disease. The CogState battery of tests consisting of the Detection test (processing speed), Identification test (attention), One Back test (working memory), International Shopping List test (verbal learning) and the Groton Maze Learning test (reasoning and problem solving) will further confirm and validate the results of the SDMT in MS patients as well as examine other cognitive domains.
The Beck Depression Inventory-II [Beck 1996] is a validated and well recognized clinical research tool for depression in the field of multiple sclerosis.
Together the above tests done prospectively can assess the evolution of cognitive function in Tysabri treated MS patients over the longer term.
- Conditions
- Multiple Sclerosis
- Being tested
- Observational Cognitive assessments
- Keywords
- Multiple Sclerosis, Cognition
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Cognitive assessmentsOther
Observational
What is being measured
The primary outcome is the main question the study is designed to answer.
SDMT
Cognitive assessment
Measured: 3 years
Cogstate Battery
Cognitive assessment
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startDec 2014
- Primary completion30 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Neuro-Outaouais
- Sponsor type
- University, hospital or other
- Collaborators
- CogState Ltd.
- Responsible party
- Sponsor
- Investigators
- Francois Jacques, MD, Principal investigator, Clinique Neuro-Outaouais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383550
- Sponsor's protocol ID
- CNO-002
- Acronym
- CogMS-Ext
- Status last verified
- Nov 2017
- First submitted
- 4 Mar 2015
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Evolution in Tysabri Treated Multiple Sclerosis Patients - A Three Year Extension
- ClinicalTrials.gov ID
- NCT02383550
- Acronym / sponsor ID
- CogMS-Ext / CNO-002
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Clinique Neuro-OutaouaisUniversity, hospital or other
- Collaborators
- CogState Ltd.
- Study start
- Dec 2014
- Primary completion
- 30 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Tysabri reduces the relapse frequency, slows progression and preserves cognitive function as compared to placebo as per the AFFIRM trial. The benefit on relapse rate and progression appears to be sustained in longer-term studies such as STRATA. In clinical practice however despite a stable EDSS patients often complain of cognitive deterioration.
The investigators' preliminary results from the first pilot study have shown that cognition in Tysabri treated MS patients for two or more years, as measured by the SDMT or Cogstate battery is maintained, including the ability to learn. The investigators' final data will be presented at the American Academy of Neurology (AAN) in 2015.
The Symbol Digit Modalities Test (SDMT) is a sensitive and validated test of cognition in MS. CogState offers a standardized battery of cognitive tests frequently used in clinical research in the fields of dementia and Parkinson's disease. The CogState battery of tests consisting of the Detection test (processing speed), Identification test (attention), One Back test (working memory), International Shopping List test (verbal learning) and the Groton Maze Learning test (reasoning and problem solving) will further confirm and validate the results of the SDMT in MS patients as well as examine other cognitive domains.
The Beck Depression Inventory-II [Beck 1996] is a validated and well recognized clinical research tool for depression in the field of multiple sclerosis.
Together the above tests done prospectively can assess the evolution of cognitive function in Tysabri treated MS patients over the longer term.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with multiple sclerosis who are receiving Tysabri per indication.
Key inclusion criteria (1 listed)
- Patients who have completed the original study and are willing to continue into the extension.
Key exclusion criteria (1 listed)
- Patients with cognitive decline from causes other than MS (i.e., PML, stroke, sleep apnea, neurodegenerative disorders, brain tumors).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Cognitive assessmentsObservational | Other | – |
Primary outcome
SDMT
Time frame: 3 years
Cognitive assessment
Cogstate Battery
Time frame: 3 years
Cognitive assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
Related trials for Multiple Sclerosis
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Recruiting
Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices
Healthy Individuals (Controls), Parkinson Disease
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Multiple Sclerosis (MS) Primary Progressive
Active, not recruiting
MS-DETECT: Early Detection of Multiple Sclerosis Progression With MSCopilot® Detect
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois Jacques, MD principal investigator
Clinique Neuro-Outaouais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Clinique Neuro-Outaouais at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SDMT (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.