Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-25 @ 4:11 AM
NCT ID:
NCT01455220
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01455220
Study Brief:
Protocol Section:
NCT01455220