Treatment With Methylprednisolone in Acute Exacerbations of Multiple Sclerosis: Enhanced Effect With Nighttime Treatment?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- The difference in mean changes in EDSS-score between the group receiving treatment during the night opposed to during the day.
研究概览
简要总结
The Immunological system is showing a diurnal rhythmicity. The Mediators that enhances inflammation are at highest level during the night. At the same time the endogenous production of cortisol is at its lowest. We want to study if there is a better effect of treatment with Methylprednisolone for acute MS-attacks if given at nighttime. The effect will be measured in relation to neurological deficits and function with Kurtzkes Expanded Disability Status Score (EDSS) and Multiple Sclerosis Functional Composite (MSFC). We want to see if the mean improvement in EDSS is greater in the group receiving treatment at night opposed to the group that get treatment during the daytime.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsing remitting MS
- •EDSS-score before the actual attack < 6.0
- •Acute MS-attack with indication for treatment with steroids
- •Symptoms >24 hours < 4 weeks
- •Age 18 years or older
排除标准
- •Prior enrollment in this study
- •Ongoing serious infection that is a contraindication for treatment with steroids
- •Pregnancy
- •Medical situations (prior acute diseases) where treatment with intravenous steroids over short period of time is contraindicated or not favorable.
- •Enhanced cognitive dysfunction
- •Treatment with p.o or i.v steroids within 3 weeks prior to date of inclusion
研究组 & 干预措施
1
Both study arms receive both active treatment = methylprednisolone and an inactive treatment = Sodium chlorid (dummy)
干预措施: methylprednisolone (Drug)
1
Both study arms receive both active treatment = methylprednisolone and an inactive treatment = Sodium chlorid (dummy)
干预措施: Sodium chlorid (Drug)
2
Both arms receives both active treatment and inactive treatment = dummy. Active treatment is methylprednisolone, inactive treatment is sodium chlorid.
干预措施: methylprednisolone (Drug)
2
Both arms receives both active treatment and inactive treatment = dummy. Active treatment is methylprednisolone, inactive treatment is sodium chlorid.
干预措施: Sodium chlorid (Drug)
结局指标
主要结局
The difference in mean changes in EDSS-score between the group receiving treatment during the night opposed to during the day.
时间窗: At admittion, directly after treatment, ca 30 days after treatment
次要结局
- Side effect registered by the patient(At admittion (baseline), during treatment, directly after treatment)
- The patient's quality of life(At admittion, directly after treatment, 7 days and ca 30 days after treatment)
- Depression(Before, after and ca 30 days after treatment)
- MRI - volume and number for MS-lesions, Gd-enhancement(At admission, directly after treatment and ca 30 days after treatment)
- The difference in MSFC-score in the two groups(At admittion, directly after treatment, ca 30 days after treatment)
- Fatigue(Before, after and ca 30 days after treatment)