The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple
The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Natalizumab
Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor
Results by group
Sexual Dysfunction (as Measured by the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) )
Baseline, 6 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Baseline to 6 Months (MSISQ-19 Scores) | -0.697 units on a scale | 0.29 (Standard Deviation) | 15 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| All Patients | 15 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Sexual Dysfunction (as Measured by the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) )
Baseline, 6 months
Bladder, bowel and sexual function
Other measures (3)
Sexual Function (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))
Baseline, 6 months
Bladder, bowel and sexual functionQuality of life (reported by participants)Health Related Quality of Life (as Measured by the Functional Assessment of MS (FAMS))
Baseline, 6 months
FatigueWalking and mobilityQuality of life (reported by participants)Quality of Life (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))
Baseline, 6 months
FatigueWalking and mobilityQuality of life (reported by participants)
Who could take part
Relapsing MS · 18 to 60
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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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History
Started
Jan 2011
Main results due
Oct 2014
Finished
Oct 2014
Results posted
Mar 2017