The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis (Tysex)

• ClinicalTrials.gov Identifier: NCT01455220
• Recruitment Status: Completed
• First Posted: October 19, 2011
• Results First Posted: March 31, 2017
• Last Update Posted: March 31, 2017
• Sponsor: University of South Florida
• Information provided by (Responsible Party): University of South Florida

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.

Condition or disease	Intervention/treatment	Phase
Multiple Sclerosis	Drug: Tysabri ® (Natalizumab)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 45 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis
• Study Start Date: January 2011
• Actual Primary Completion Date: October 2014
• Actual Study Completion Date: October 2014

Arms and Interventions

Intervention Details:

• Drug: Tysabri ® (Natalizumab)
  IV, monthly

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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).
2. 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.
3. Quality of Life (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54)) [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Florida

University of South Florida, Frank and Carol Morsani Center

Tampa, Florida, United States, 33612

Sponsors and Collaborators

University of South Florida

Investigators

• Principal Investigator: Tuan Vu, MD; University of South Florida

More Information

Additional Information:

USF Multiple Sclerosis Center 

• Responsible Party: University of South Florida
• ClinicalTrials.gov Identifier: NCT01455220
• Other Study ID Numbers: US-TYS-10-10057
• First Posted: October 19, 2011
• Results First Posted: March 31, 2017
• Last Update Posted: March 31, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by University of South Florida:

Multiple Sclerosis; Sexual Dysfunction; Quality of Life

Additional relevant MeSH terms:

Multiple Sclerosis; Sclerosis; Pathologic Processes; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Natalizumab; Immunologic Factors; Physiological Effects of Drugs