NCT01111435Unknown不适用
A Prospective Study of Spasticity in Individuals With Multiple Sclerosis in Transition From Interferon to Glatiramer Acetate (Copaxone®)
Fraser, Cira, Ph.D., RN, ACNS-BC1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2010年4月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Multiple Sclerosis Spasticity Scale
研究概览
简要总结
This study is expected to contribute to the body of knowledge on the benefits of individuals with MS taking glatiramer acetate (Copaxone®). If patients have less spasticity when taking glatiramer acetate (Copaxone®), they may be more likely to have an improved quality of life.
The hypotheses for this study are:
- Study participants who transition from interferon therapy to glatiramer acetate (Copaxone®) for a six month period will have a decrease in spasticity.
- Study participants who transition from interferon therapy to glatiramer acetate (Copaxone®) for a six month period will have a change in perceptions of the impact of spasticity on their lives.
详细描述
The purpose of this study is to determine if there is a change in spasticity and perceptions of the impact of spasticity in individuals with multiple sclerosis who transition from interferon to glatiramer acetate (Copaxone®).•
- Potential participants meeting the criteria will be identified by Shared Solutions and informed of the study. Interested individuals will contact the investigator either by email or telephone. Enrollment will continue until there are 110 participants starting glatiramer acetate (Copaxone®).
- Potential participants will be informed of the details of the study, eligibility will be confirmed, and participant's questions answered.
- The two study instruments and the sociodemographic questionnaire will be emailed or mailed via UPS along with an information letter. May be returned either via email, fax or UPS mail.
- At month 6 for each participant, the study instruments and sociodemographic questionnaire will be sent a second time and returned to the investigator.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Stopped interferon (beta-1a or beta-1b) within the past 30 days
- •About to start or started glatiramer acetate (Copaxone®) within the past 21 days.
- •At least 18 years of age
- •Has spasticity at the beginning of the study
- •Able to ambulate with unilateral support or without support
- •Understands, speaks and reads English
排除标准
- •Severe Gait Disability or Total Gait Disability
结局指标
主要结局
Multiple Sclerosis Spasticity Scale
时间窗: Administered at 6 month follow-up
次要结局
- Performance Scales (Measure of Disability)(Administered at 6 month follow-up)
研究者
Cira Fraser PhD, RN, ACNS-BC
Associate Professor
Fraser, Cira, Ph.D., RN, ACNS-BC
研究点 (1)
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