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Trial record 9 of 2246 for:    MULTIPLE SCLEROSIS

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

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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:
Information provided by (Responsible Party):
University of South Florida

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Multiple Sclerosis
Intervention Drug: Tysabri ® (Natalizumab)
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Patients
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 45
Completed 15
Not Completed 30
Reason Not Completed
screen fail             30
Arm/Group Title Tysabri
Hide Arm/Group Description All patients were receiving commercial Tysabri
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
11
  73.3%
Male
4
  26.7%
1.Primary Outcome
Title Sexual Dysfunction (as Measured by the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) )
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline to 6 Months (MSISQ-19 Scores)
Hide Arm/Group Description:
All enrolled participants
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.697  (0.29)
2.Secondary Outcome
Title Sexual Function (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MSQOL-54, Physical (Baseline to 6 Months)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.29  (0.67)
3.Secondary Outcome
Title Health Related Quality of Life (as Measured by the Functional Assessment of MS (FAMS))
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FAMS (Baseline to 6 Months)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.57  (0.99)
4.Secondary Outcome
Title Quality of Life (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MSQOL-54 Total (Baseline to 6 Months)
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 15
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.73  (0.71)
Time Frame From signing of the consent to last visit (month 6)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients
Hide Arm/Group Description no Adverse events were experienced
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Patients
Affected / at Risk (%)
Total   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Patients
Affected / at Risk (%)
Total   0/15 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr.Tuan Vu/ Dr. Derrick Robertson
Organization: University of South Florida
Phone: 813-974-6378
EMail: droberts@health.usf.edu
Layout table for additonal information
Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01455220     History of Changes
Other Study ID Numbers: US-TYS-10-10057
First Submitted: October 10, 2011
First Posted: October 19, 2011
Results First Submitted: May 10, 2016
Results First Posted: March 31, 2017
Last Update Posted: March 31, 2017