Multiple SclerosisNCT01335633
Psychometric Validation of Cognitive Endpoints
An observational study of Multiple Sclerosis, run by Kessler Foundation at 4 sites in United States.
Trial summary
The study will entail cognitive assessment of a single cohort of patients with Multiple Sclerosis. Each subject will be assessed twice, approximately 45 days apart. There will be no intervention or control group. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- Mar 2011to Aug 2011
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with Multiple Sclerosis
Who may be able to join
- 18 to 65 years old (inclusive).
- History of Relapsing-Remitting or Secondary Progressive Multiple Sclerosis
- Physically able to see the testing materials and complete the tests
- Have a family member or caregiver who is capable of consent and willing to complete the MSNQ-Informant questionnaire.
Who cannot join
- A history of treated or untreated severe mental illness or diagnosis of major depression prior to MS onset.
- Untreated major depression or untreated anxiety disorder.
- History of Attention Deficit/Hyperactivity Disorder, Developmental Learning - Disorder including Mental Retardation.
- History of traumatic brain injury with intracranial bleed, stroke, Alzheimer's disease, Parkinson's disease, Motor Coordination Disorder or other neurologic illness. I understand that if the Investigator believes this would interfere with successful completion of the protocol, I will be excluded.
- A clinically significant relapse within the past 2 months. I have had a serious infection (e.g., pneumonia, septicemia) within the 2 month.
- History of drug or alcohol abuse (as defined by the Investigator) within 1 year prior to Study Day 1.
Show all 11Show fewer
- Active bacterial or viral infection.
- Use of marijuana within 2 months prior to Study Day 1or at any time during the study
- Alcohol consumption within 24 hours of either test session.
- Unable to comply with study requirements.
- Expected survival time of less than 3 months.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University at Buffalo
Buffalo, New York, 14203
Holy Name Hospital Multiple Sclerosis Center
Teaneck, New Jersey, 07666
Kessler Foundation
West Orange, New Jersey, 07052
Lauren S. Caruso
White Plains, New York, 10604
About this study
The study will entail cognitive assessment of a single cohort of patients with Multiple Sclerosis. Each subject will be assessed twice, approximately 45 days apart. There will be no intervention or control group. Each participant will have a caregiver capable of responding to a brief report of observations regarding neuropsychological skills and abilities in the patient.
- Conditions
- Multiple Sclerosis
- Keywords
- MS, Neuropsychological tests
- Medical subject headings
- Multiple Sclerosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2011
- Study completionAug 2011
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Biogen
- Responsible party
- Principal investigator, John DeLuca, Kessler Foundation
- Investigators
- John DeLuca, Ph.D., Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335633
- Sponsor's protocol ID
- 691-11 PVCE
- Status last verified
- May 2012
- First submitted
- 13 Apr 2011
- Last updated
- 3 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Validation of Cognitive Endpoints
- ClinicalTrials.gov ID
- NCT01335633
- Acronym / sponsor ID
- 691-11 PVCE
- Conditions
- Multiple Sclerosis
- Keywords
- MS, Neuropsychological tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- Biogen
- Study start
- Mar 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 14 Apr 2011 (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.
The study will entail cognitive assessment of a single cohort of patients with Multiple Sclerosis. Each subject will be assessed twice, approximately 45 days apart. There will be no intervention or control group. Each participant will have a caregiver capable of responding to a brief report of observations regarding neuropsychological skills and abilities in the patient.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with Multiple Sclerosis
Key inclusion criteria (4 listed)
- 18 to 65 years old (inclusive).
- History of Relapsing-Remitting or Secondary Progressive Multiple Sclerosis
- Physically able to see the testing materials and complete the tests
- Have a family member or caregiver who is capable of consent and willing to complete the MSNQ-Informant questionnaire.
Key exclusion criteria (11 listed)
- A history of treated or untreated severe mental illness or diagnosis of major depression prior to MS onset.
- Untreated major depression or untreated anxiety disorder.
- History of Attention Deficit/Hyperactivity Disorder, Developmental Learning - Disorder including Mental Retardation.
- History of traumatic brain injury with intracranial bleed, stroke, Alzheimer's disease, Parkinson's disease, Motor Coordination Disorder or other neurologic illness. I understand that if the Investigator believes this would interfere with successful completion of the protocol, I will be excluded.
- A clinically significant relapse within the past 2 months. I have had a serious infection (e.g., pneumonia, septicemia) within the 2 month.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 3 May 2012.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Efgartigimod for the Treatment of Acute Optic Neuritis
Optic Neuritis
Active, not recruitingPhase 3
A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 3
An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment
Multiple Sclerosis
Active, not recruitingObservational study
Early Versus Late Ofatumumab (Kesimpta®) Use in Austrian RMS-Patients Over 2 Years
Relapsing Multiple Sclerosis
Not yet recruiting
Neurogenetics and Multi-omics of Neuroinflammatory Diseases in Multiplex Families to Improve Patients Health
Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorder
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.
John DeLuca, Ph.D. principal investigator
Kessler Foundation
4 sites 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 Kessler Foundation at 4 sites in United States.
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 4 inclusion and 11 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 3 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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.
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 3 May 2012.