Back to resultsThe Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis (Tysex)
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tysabri ® (Natalizumab)
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Sexual Dysfunction, Quality of Life
Eligibility Criteria
Inclusion Criteria:
- Must give written informed consent and provide all authorizations required by local law(ex. Protected Health Information, PHI)
- Minimum baseline score of 15 for the primary sexual dysfunction subscale of the MSISQ-19 (questions 12,16,17,18,19)
- Men and Women between 18 and 60 years of age
- Must have EDSS less than or equal to 5.5 at baseline
- Must be able to walk at least 100m without assistive devices
- Must have a documented diagnosis of a relapsing remitting form of MS as defined by the revised McDonald Committee criteria (Polman et al.,2005)
- Must have a recent MRI (within 1 year from baseline)
- Must satisfy the locally approved therapeutic indications for TYSABRI
- Must be stable in disability for at least 30 days prior to enrollment to the study
- Must be Natalizumab naïve
- Must be stable in symptomatic management of the disease, for at least 30 days prior to enrollment in the study
- 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.
- 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.
- 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:
- Must give written informed consent and provide all authorizations required by local law(ex. Protected Health Information, PHI)
- Minimum baseline score of 15 for the primary sexual dysfunction subscale of the MSISQ-19 (questions 12,16,17,18,19)
- Men and Women between 18 and 60 years of age
- Must have EDSS less than or equal to 5.5 at baseline
- Must be able to walk at least 100m without assistive devices
- Must have a documented diagnosis of a relapsing remitting form of MS as defined by the revised McDonald Committee criteria (Polman et al.,2005)
- Must have a recent MRI (within 1 year from baseline)
- Must satisfy the locally approved therapeutic indications for TYSABRI
- Must be stable in disability for at least 30 days prior to enrollment to the study
- Must be Natalizumab naïve
- Must be stable in symptomatic management of the disease, for at least 30 days prior to enrollment in the study
- 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.
- 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.
- 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
Sites / Locations
- University of South Florida, Frank and Carol Morsani Center
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
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.
Full Information
NCT ID
NCT01455220
First Posted
October 10, 2011
Last Updated
February 14, 2017
Sponsor
University of South Florida
1. Study Identification
Unique Protocol Identification Number
NCT01455220
Brief Title
The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis
Acronym
Tysex
Official Title
The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Sexual Dysfunction, Quality of Life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tysabri ® (Natalizumab)
Intervention Description
IV, monthly
Primary Outcome Measure Information:
Title
Sexual Dysfunction (as Measured by the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) )
Description
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
Secondary Outcome Measure Information:
Title
Sexual Function (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))
Description
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
Title
Health Related Quality of Life (as Measured by the Functional Assessment of MS (FAMS))
Description
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
Title
Quality of Life (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must give written informed consent and provide all authorizations required by local law(ex. Protected Health Information, PHI)
Minimum baseline score of 15 for the primary sexual dysfunction subscale of the MSISQ-19 (questions 12,16,17,18,19)
Men and Women between 18 and 60 years of age
Must have EDSS less than or equal to 5.5 at baseline
Must be able to walk at least 100m without assistive devices
Must have a documented diagnosis of a relapsing remitting form of MS as defined by the revised McDonald Committee criteria (Polman et al.,2005)
Must have a recent MRI (within 1 year from baseline)
Must satisfy the locally approved therapeutic indications for TYSABRI
Must be stable in disability for at least 30 days prior to enrollment to the study
Must be Natalizumab naïve
Must be stable in symptomatic management of the disease, for at least 30 days prior to enrollment in the study
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.
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.
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:
Must give written informed consent and provide all authorizations required by local law(ex. Protected Health Information, PHI)
Minimum baseline score of 15 for the primary sexual dysfunction subscale of the MSISQ-19 (questions 12,16,17,18,19)
Men and Women between 18 and 60 years of age
Must have EDSS less than or equal to 5.5 at baseline
Must be able to walk at least 100m without assistive devices
Must have a documented diagnosis of a relapsing remitting form of MS as defined by the revised McDonald Committee criteria (Polman et al.,2005)
Must have a recent MRI (within 1 year from baseline)
Must satisfy the locally approved therapeutic indications for TYSABRI
Must be stable in disability for at least 30 days prior to enrollment to the study
Must be Natalizumab naïve
Must be stable in symptomatic management of the disease, for at least 30 days prior to enrollment in the study
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.
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tuan Vu, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida, Frank and Carol Morsani Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis
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