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

NCT01455220 | Completed Results

• 1 other identifier: US-TYS-10-10057
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Sexual Dysfunction; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Sexual Dysfunction (as Measured by the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) )

  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.

  Baseline, 6 months

Secondary Outcomes (3)

• Sexual Function (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))

  Baseline, 6 months

• Health Related Quality of Life (as Measured by the Functional Assessment of MS (FAMS))

  Baseline, 6 months

• Quality of Life (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))

  Baseline, 6 months

Interventions

Tysabri ® (Natalizumab) DRUG

IV, monthly

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Must give written informed consent and provide all authorizations required by local law(ex. Protected Health Information, PHI)
• Minimum baseline score of 15 for the primary sexual dysfunction subscale of the MSISQ-19 (questions 12,16,17,18,19)
• Men and Women between 18 and 60 years of age
• Must have EDSS less than or equal to 5.5 at baseline
• Must be able to walk at least 100m without assistive devices
• Must have a documented diagnosis of a relapsing remitting form of MS as defined by the revised McDonald Committee criteria (Polman et al.,2005)
• Must have a recent MRI (within 1 year from baseline)
• Must satisfy the locally approved therapeutic indications for TYSABRI
• Must be stable in disability for at least 30 days prior to enrollment to the study
• Must be Natalizumab naïve
• Must be stable in symptomatic management of the disease, for at least 30 days prior to enrollment in the study
• 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.
• 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.
• 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

You may not qualify if:

• Must give written informed consent and provide all authorizations required by local law(ex. Protected Health Information, PHI)
• Minimum baseline score of 15 for the primary sexual dysfunction subscale of the MSISQ-19 (questions 12,16,17,18,19)
• Men and Women between 18 and 60 years of age
• Must have EDSS less than or equal to 5.5 at baseline
• Must be able to walk at least 100m without assistive devices
• Must have a documented diagnosis of a relapsing remitting form of MS as defined by the revised McDonald Committee criteria (Polman et al.,2005)
• Must have a recent MRI (within 1 year from baseline)
• Must satisfy the locally approved therapeutic indications for TYSABRI
• Must be stable in disability for at least 30 days prior to enrollment to the study
• Must be Natalizumab naïve
• Must be stable in symptomatic management of the disease, for at least 30 days prior to enrollment in the study
• 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.
• 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.
• 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida, Frank and Carol Morsani Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Sexual Dysfunction, Physiological

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr.Tuan Vu/ Dr. Derrick Robertson
• Organization: University of South Florida

droberts@health.usf.edu

813-974-6378

Study Officials

• Tuan Vu, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2011
• First Posted: October 19, 2011
• Study Start: January 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 31, 2017
• Results First Posted: March 31, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)