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

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