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
  Purpose

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 Intervention
Multiple Sclerosis
Drug: Tysabri ® (Natalizumab)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 30
Study Start Date: January 2011
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Tysabri ® (Natalizumab)
    IV, monthly
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455220

Locations
United States, Florida
University of South Florida, Frank and Carol Morsani Center Recruiting
Tampa, Florida, United States, 33612
Contact: Angela Seevers, MPH    813-974-6378      
Contact: Lise Casady, ARNP    813-396-9478      
Principal Investigator: Tuan Vu, MD         
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Tuan Vu, MD University of South Florida
  More Information

Additional Information:
No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01455220     History of Changes
Other Study ID Numbers: US-TYS-10-10057
Study First Received: October 10, 2011
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
Multiple Sclerosis
Sexual Dysfunction
Quality of Life

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 29, 2014