Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Sexual Dysfunction, Quality of Life
Brief summary
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.
Detailed description
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.
Interventions
DRUGTysabri ® (Natalizumab)
IV, monthly
Sponsors
University of South Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Must give written informed consent and provide all authorizations required by local law(ex. Protected Health Information, PHI) 2. Minimum baseline score of 15 for the primary sexual dysfunction subscale of the MSISQ-19 (questions 12,16,17,18,19) 3. Men and Women between 18 and 60 years of age 4. Must have EDSS less than or equal to 5.5 at baseline 5. Must be able to walk at least 100m without assistive devices 6. Must have a documented diagnosis of a relapsing remitting form of MS as defined by the revised McDonald Committee criteria (Polman et al.,2005) 7. Must have a recent MRI (within 1 year from baseline) 8. Must satisfy the locally approved therapeutic indications for TYSABRI 9. Must be stable in disability for at least 30 days prior to enrollment to the study 10. Must be Natalizumab naïve 11. Must be stable in symptomatic management of the disease, for at least 30 days prior to enrollment in the study 12. Must be on a stable regimen of all symptomatic medications for Multiple Sclerosis especially those that could interfere with sexual function (specifically anti-cholinergics, anti-hypertensives, etc.) for at least 30 days prior to the enrollment. 13. Must be considered by the Investigator to be free of signs and symptoms suggestive of PML based on medical history, physical examination, or laboratory testing. 14. Must be willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFN and GA) while being treated with Natalizumab during the study
Exclusion criteria
1. Must give written informed consent and provide all authorizations required by local law(ex. Protected Health Information, PHI) 2. Minimum baseline score of 15 for the primary sexual dysfunction subscale of the MSISQ-19 (questions 12,16,17,18,19) 3. Men and Women between 18 and 60 years of age 4. Must have EDSS less than or equal to 5.5 at baseline 5. Must be able to walk at least 100m without assistive devices 6. Must have a documented diagnosis of a relapsing remitting form of MS as defined by the revised McDonald Committee criteria (Polman et al.,2005) 7. Must have a recent MRI (within 1 year from baseline) 8. Must satisfy the locally approved therapeutic indications for TYSABRI 9. Must be stable in disability for at least 30 days prior to enrollment to the study 10. Must be Natalizumab naïve 11. Must be stable in symptomatic management of the disease, for at least 30 days prior to enrollment in the study 12. Must be on a stable regimen of all symptomatic medications for Multiple Sclerosis especially those that could interfere with sexual function (specifically anti-cholinergics, anti-hypertensives, etc.) for at least 30 days prior to the enrollment. 13. Must be considered by the Investigator to be free of signs and symptoms suggestive of PML based on medical history, physical examination, or laboratory testing. 14. Must be willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFN and GA) while being treated with Natalizumab during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sexual Dysfunction (as Measured by the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) ) | Baseline, 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexual Function (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54)) | Baseline, 6 months | 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). |
| Health Related Quality of Life (as Measured by the Functional Assessment of MS (FAMS)) | Baseline, 6 months | 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. |
| Quality of Life (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54)) | Baseline, 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tysabri All patients were receiving commercial Tysabri | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | screen fail | 30 |
Baseline characteristics
| Characteristic | Tysabri |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
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.
Time frame: Baseline, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline to 6 Months (MSISQ-19 Scores) | Sexual Dysfunction (as Measured by the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) ) | -0.697 units on a scale | Standard Deviation 0.29 |
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.
Time frame: Baseline, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline to 6 Months (MSISQ-19 Scores) | Health Related Quality of Life (as Measured by the Functional Assessment of MS (FAMS)) | 2.57 units on a scale | Standard Deviation 0.99 |
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.
Time frame: Baseline, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline to 6 Months (MSISQ-19 Scores) | Quality of Life (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54)) | 0.73 units on a scale | Standard Deviation 0.71 |
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).
Time frame: Baseline, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline to 6 Months (MSISQ-19 Scores) | Sexual Function (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54)) | 0.29 units on a scale | Standard Deviation 0.67 |