Trial Outcomes & Findings for The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis (NCT NCT01455220)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

Baseline, 6 months

Results posted on

2017-03-31

Participant Flow

Participant milestones

Participant milestones
Measure	All Patients
Overall Study STARTED	45
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	30

Reasons for withdrawal

Reasons for withdrawal
Measure	All Patients
Overall Study screen fail	30

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tysabri n=15 Participants All patients were receiving commercial Tysabri
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Baseline to 6 Months (MSISQ-19 Scores) n=15 Participants All enrolled participants
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 outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Baseline to 6 Months (MSISQ-19 Scores) n=15 Participants All enrolled participants
Sexual Function (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))	0.29 units on a scale Standard Deviation 0.67

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Baseline to 6 Months (MSISQ-19 Scores) n=15 Participants All enrolled participants
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 outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Baseline to 6 Months (MSISQ-19 Scores) n=15 Participants All enrolled participants
Quality of Life (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))	0.73 units on a scale Standard Deviation 0.71

Adverse Events

All Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Tuan Vu/ Dr. Derrick Robertson

University of South Florida

Phone: 813-974-6378

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place