- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01455220
The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis (Tysex)
February 14, 2017 updated by: University of South Florida
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Tampa, Florida, United States, 33612
- University of South Florida, Frank and Carol Morsani Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexual Dysfunction (as Measured by the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) )
Time Frame: 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.
|
Baseline, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexual Function (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))
Time Frame: 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).
|
Baseline, 6 months
|
Health Related Quality of Life (as Measured by the Functional Assessment of MS (FAMS))
Time Frame: 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.
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Baseline, 6 months
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Quality of Life (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))
Time Frame: Baseline, 6 months
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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.
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Baseline, 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tuan Vu, MD, University of South Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
October 1, 2014
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
October 10, 2011
First Submitted That Met QC Criteria
October 17, 2011
First Posted (Estimate)
October 19, 2011
Study Record Updates
Last Update Posted (Actual)
March 31, 2017
Last Update Submitted That Met QC Criteria
February 14, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- US-TYS-10-10057
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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