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The purpose of this study is to determine if sexual dysfunction symptoms and quality of life measures in patients with Multiple Sclerosis may be improved in patients that are prescribed Tysabri.
Patients will be naive to Tysabri at the baseline for this study then their sexual dysfunction, fatigue, and quality of life measures will be measured using scaled questionnaires.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tysabri ® (Natalizumab) | Drug | IV, monthly |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual Dysfunction (as Measured by the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) ) | Change in level of dysfunction demonstrated by the comparison and analysis of Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) responses at end of study to baseline. Minimum score of 19 to maximum score of 95, the higher score indicates a greater level of sexual dysfunction. Primary subscale (min 5 to max 25), Secondary subscale (min 9 to max 45), tertiary subscale (min 5 to max 25), subscale scores are summed for overall total score. | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual Function (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54)) | Change in composite score in the sexual function subscale of the Multiple Sclerosis Quality of Life (MSQOL-54) over 6 months of Natalizumab treatment. Minimum score of 0 and max score of 100. A higher score indicates a more positive outcome (less sexual dysfunction). | Baseline, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tuan Vu, MD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida, Frank and Carol Morsani Center | Tampa | Florida | 33612 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tysabri | All patients were receiving commercial Tysabri |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sexual Dysfunction (as Measured by the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) ) | Change in level of dysfunction demonstrated by the comparison and analysis of Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) responses at end of study to baseline. Minimum score of 19 to maximum score of 95, the higher score indicates a greater level of sexual dysfunction. Primary subscale (min 5 to max 25), Secondary subscale (min 9 to max 45), tertiary subscale (min 5 to max 25), subscale scores are summed for overall total score. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months |
|
From signing of the consent to last visit (month 6)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | no Adverse events were experienced |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Tuan Vu/ Dr. Derrick Robertson | University of South Florida | 813-974-6378 | droberts@health.usf.edu |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000069442 | Natalizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Health Related Quality of Life (as Measured by the Functional Assessment of MS (FAMS)) | Change in score on the Functional Assessment of MS (FAMS) questionnaire.The FAMS consists of 44 scored items in six quality-of-life domains: Mobility (seven items), Symptoms (seven items), Emotional well being (seven items), General contentment (seven items), Thinking/fatigue (nine items), and Family/social well being (seven items). Minimum score of 0 to max score of 176. A higher scores indicates positive (better) functional health related quality. | Baseline, 6 months |
| Quality of Life (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54)) | Change in score on the Multiple Sclerosis Quality of Life (MSQOL-54) from end of study compared to baseline. The MSQOL-54 is a 54-item quality of life questionnaire that has general, as well as, MS specific questions covered in 6 sub-categories (mobility, symptoms, emotional well-being, general contentment, thinking and fatigue, family/social well-being). Minimum score of 0 to maximum score of 100. Overall quality of life is calculated by averaging question 53 and 54. The sub-scales( mental and physical health) are on a weighted scale. Sets of questions are totaled and divided by the number of questions in each section then that section total is multiplied by a weighted value. Then all weighted values are summed for all relevant question sections for that subscale to compute a composite score for both mental health and physical health. A higher score, indicates a higher perceived quality of life for the patient. A lower scorer indicates poorer quality of life impacted by MS. | Baseline, 6 months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Sexual Function (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54)) | Change in composite score in the sexual function subscale of the Multiple Sclerosis Quality of Life (MSQOL-54) over 6 months of Natalizumab treatment. Minimum score of 0 and max score of 100. A higher score indicates a more positive outcome (less sexual dysfunction). | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months |
|
|
|
| Secondary | Health Related Quality of Life (as Measured by the Functional Assessment of MS (FAMS)) | Change in score on the Functional Assessment of MS (FAMS) questionnaire.The FAMS consists of 44 scored items in six quality-of-life domains: Mobility (seven items), Symptoms (seven items), Emotional well being (seven items), General contentment (seven items), Thinking/fatigue (nine items), and Family/social well being (seven items). Minimum score of 0 to max score of 176. A higher scores indicates positive (better) functional health related quality. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months |
|
|
|
| Secondary | Quality of Life (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54)) | Change in score on the Multiple Sclerosis Quality of Life (MSQOL-54) from end of study compared to baseline. The MSQOL-54 is a 54-item quality of life questionnaire that has general, as well as, MS specific questions covered in 6 sub-categories (mobility, symptoms, emotional well-being, general contentment, thinking and fatigue, family/social well-being). Minimum score of 0 to maximum score of 100. Overall quality of life is calculated by averaging question 53 and 54. The sub-scales( mental and physical health) are on a weighted scale. Sets of questions are totaled and divided by the number of questions in each section then that section total is multiplied by a weighted value. Then all weighted values are summed for all relevant question sections for that subscale to compute a composite score for both mental health and physical health. A higher score, indicates a higher perceived quality of life for the patient. A lower scorer indicates poorer quality of life impacted by MS. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 months |
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|
| 0 |
| 15 |
| 0 |
| 15 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |