Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of South Florida
Sponsor:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01455220
First received: October 10, 2011
Last updated: May 5, 2014
Last verified: May 2014

October 10, 2011
May 5, 2014
January 2011
October 2014   (final data collection date for primary outcome measure)
Sexual Dysfunction [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
Decrease in level of dysfunction demonstrated by the comparison and analysis of MSISQ-19 responses at end of study to baseline
Same as current
Complete list of historical versions of study NCT01455220 on ClinicalTrials.gov Archive Site
  • Sexual Function [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    • 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
  • Fatigue [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    Improved score on the FAMS questionnaire fatigue scale for MS
  • Quality of Life [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
    • Improved score on the MSQOL-54 from end of study compared to baseline
    • Improvement shown in the sexual function component of the MSQOL-54
Same as current
Not Provided
Not Provided
 
The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis
The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Multiple Sclerosis
Drug: Tysabri ® (Natalizumab)
IV, monthly
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
United States
 
NCT01455220
US-TYS-10-10057
No
University of South Florida
University of South Florida
Not Provided
Principal Investigator: Tuan Vu, MD University of South Florida
University of South Florida
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP