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

Multiple Sclerosis Clinical Trial

— Tysex  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01455220
• Other study ID #: US-TYS-10-10057
• Status: Completed
• Phase: N/A
• First received: October 10, 2011
• Last updated: December 2, 2014
• Start date: January 2011
• Est. completion date: October 2014

Study information

• Verified date: December 2014
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Tysabri ® (Natalizumab)
IV, monthly

Locations

Country	Name	City	State
United States	University of South Florida, Frank and Carol Morsani Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual Dysfunction	Decrease in level of dysfunction demonstrated by the comparison and analysis of MSISQ-19 responses at end of study to baseline	Baseline, 6 months	No
Secondary	Sexual Function	Change in composite score in the sexual function subscale of the MSQOL-54 over 6 months of Natalizumab treatment; Improvement shown in at least one area designated in the MSISQ-19	Baseline, 6 months	No
Secondary	Fatigue	Improved score on the FAMS questionnaire fatigue scale for MS	Baseline, 6 months	No
Secondary	Quality of Life	Improved score on the MSQOL-54 from end of study compared to baseline; Improvement shown in the sexual function component of the MSQOL-54	Baseline, 6 months	No

External Links

•   USF Multiple Sclerosis Center