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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 October 2015 |
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Main ID: |
NCT02283918 |
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Date of registration:
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03/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Observational Study to Establish Patient-Matched Population Norms for the Multiple Sclerosis Cognition Assessment Battery
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Scientific title:
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Study to Establish Patient-Matched Population Norms for the MS-COG |
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Date of first enrolment:
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November 2014 |
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Target sample size:
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467 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02283918 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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France
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Italy
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United States
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Biogen |
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Key inclusion & exclusion criteria
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Key Inclusion Criteria
1. Ability to understand the purpose and risks of the study and provide signed and dated
informed consent and authorization to use confidential health information in
accordance with national and local subject privacy regulations.
2. Must be in good health as determined by the Investigator, based on medical history,
physical examination, and Screening evaluations.
3. Must be a native language speaker of the country where the study is being conducted.
Key Exclusion Criteria:
1. Neurological illnesses/conditions, such as motor or vocal tics (including a diagnosis
of Tourette's syndrome), head trauma with significant loss of consciousness (>30
min), cerebral ischemia, carotid artery disease, epilepsy, brain tumor, dementia
(including mild cognitive impairment and Alzheimer's disease), chronic meningitis,
multiple sclerosis, pernicious anemia, normal-pressure hydrocephalus, HIV infection,
Parkinson's disease, and Huntington's disease.
2. Medical illnesses/conditions that may affect brain function, such as untreated
hypertension (blood pressure >140/100 mm Hg), cardiac disease, insulin-dependent
diabetes mellitus, endocrine disorders, renal disease, glaucoma, and chronic
obstructive pulmonary disease.
3. Major psychiatric disturbance according to the Diagnostic and Statistical Manual of
Mental Disorders, 5th edition (US) Axis I criteria [American Psychiatric Association
2013] and the International Statistical Classification of Diseases and Related Health
Problems, 10th revision Axis I criteria (Europe) [WHO 2010].
4. History of developmental disorders.
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Age minimum:
25 Years
Age maximum:
58 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy
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Primary Outcome(s)
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Symbol Digit Modalities Test (SDMT) Score
[Time Frame: Day 1]
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Selective Reminding Test (SRT) Score
[Time Frame: Day 1]
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Brief Visuospatial Memory Test-Revised (BVMT-R) Score
[Time Frame: Day 1]
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2- second and 3-second Paced Auditory Serial Addition Test (PASAT) Score
[Time Frame: Day 1]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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