NCT01455220已完成不适用
The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple Sclerosis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Sexual Dysfunction (as Measured by the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) )
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Sexual Dysfunction (as Measured by the Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) )
时间窗: Baseline, 6 months
Change in level of dysfunction demonstrated by the comparison and analysis of Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) responses at end of study to baseline. Minimum score of 19 to maximum score of 95, the higher score indicates a greater level of sexual dysfunction. Primary subscale (min 5 to max 25), Secondary subscale (min 9 to max 45), tertiary subscale (min 5 to max 25), subscale scores are summed for overall total score.
次要结局
- Sexual Function (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))(Baseline, 6 months)
- Quality of Life (as Measured by the Multiple Sclerosis Quality of Life (MSQOL-54))(Baseline, 6 months)
- Health Related Quality of Life (as Measured by the Functional Assessment of MS (FAMS))(Baseline, 6 months)
研究者
研究点 (1)
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