Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
1 participants
INTERVENTIONAL
2022-09-16
2023-04-05
Brief Summary
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Detailed Description
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As a corollary aim, the investigators will assess changes in quality of life (QoL) measurements and the relation between those measurements and those derived from the above detailed quantitative MRI methods. QoL will be measured using the Visual Analogue Scale. This questionnaire entails 13 questions regarding the perceived effect of Tysabri, but also level of pain, fatigue, anxiety, depression before and during treatment with natalizumab. The answer to each question is rated on a color-coded bar the range of which is between 0 to 100.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Single Arm
SINGLE ARM: 30 patients with multiple sclerosis treated with Natlizumab infusion given monthly at the dose of 300 mg IV
Natalizumab 300 MG in 15 ML Injection
Disease modifying agent
Interventions
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Natalizumab 300 MG in 15 ML Injection
Disease modifying agent
Eligibility Criteria
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Inclusion Criteria
2. clinical eligibility to treatment with Natalizumab
3. no previous exposure to Natalizumab treatment
Exclusion Criteria
2. inability to undergo a paper-pencil questionnaires and blood work
18 Years
65 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Vanderbilt University Medical Center
OTHER
Responsible Party
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Francesca Bagnato
Assistant Professor
Principal Investigators
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Francesca Bagnato, MDPhD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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201600
Identifier Type: -
Identifier Source: org_study_id
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