View Clinical Trial (Medical Research Study)
The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis
| City: |
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Tampa |
| State: |
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Florida |
| Zip Code: |
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33612 |
| Conditions: |
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Multiple Sclerosis |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01455220 |
| Primary Contact: |
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Principal Investigator
Tuan Vu, MD
University of South Florida
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| Backup Contact: |
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N/A |
| Location Contact: |
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Tampa, Florida 33612
United States
Angela Seevers, MPH
Phone: 813-974-6378
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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