N/A
N=45
The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT01455220 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Sexual Dysfunction (as Measured by the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) ) — -0.697 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tysabri ® (Natalizumab) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of South Florida
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sexual Dysfunction (as Measured by the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) ) |
-0.697 | — |
| SECONDARY Sexual Function (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54)) |
0.29 | — |
| SECONDARY Health Related Quality of Life (as Measured by the Functional Assessment of MS (FAMS)) |
2.57 | — |
| SECONDARY Quality of Life (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54)) |
0.73 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01455220). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.