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临床试验/NCT00919217
NCT00919217终止不适用

Exploratory Study on the Timing of MS Symptoms

University of Louisville2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2008年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
80
试验地点
2
主要终点
number of days with appearance or worsening of symptoms

研究概览

简要总结

The investigators' overall hypothesis is that appearance or worsening of relapsing-remitting multiple sclerosis (RR-MS) symptoms are affected by various factors including stress, hormonal cycles, illness and missed medications.

详细描述

Fluctuations in MS symptoms in women with RR-MS might be affected by a variety of factors. To determine which factors are important, we are asking subjects to fill out a diary and calendar on a daily basis for 90 days. After an initial instructional meeting over the phone, the materials are filled out at home and returned monthly via postage-paid envelopes provided by the study. Compensation ($10 gift card) is sent after each monthly diary is received. The diary includes a list of symptoms and a rank scale for the women to show subtle changes in MS symptoms. The calendar allows the subject to denote additional factors such as stress, hormonal cycles, illnesses or immunizations and changed or missed medications. We anticipate that statistical analysis will reveal which of these factors affect women with relapsing-remitting multiple sclerosis.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • diagnosed with relapsing-remitting multiple sclerosis

排除标准

  • no diagnosis of relapsing-remitting MS
  • diagnosis of any other autoimmune disease or fibromyalgia
  • peri-, post-, or surgically menopausal
  • pregnant within past year or nursing
  • history of chemotherapy
  • on experimental medications
  • treatment with steroids in the last 30 days

研究组 & 干预措施

Relapsing-remitting multiple sclerosis

Females with relapsing-remitting multiple sclerosis

结局指标

主要结局

number of days with appearance or worsening of symptoms

时间窗: 3 months

次要结局

  • timing of appearance or worsening of symptoms(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cynthia Corbitt

Associate Professor

University of Louisville

研究点 (2)

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