A Multicenter, Randomized, Double Blind, Placebo Controlled Parallel Group, Pilot Study to Assess the Efficacy and Safety of Acthar® in Subjects With Relapsing-remitting Multiple Sclerosis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 22
- 主要终点
- Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42
研究概览
简要总结
This study will enroll about 66 participants who experienced a relapse of RRMS that steroids did not help. The doctor will put participants into a treatment group. Each person has an equal chance of being in either one of two groups (like flipping a coin). One group will receive a shot of study medicine (called Acthar Gel) under their skin every day for 14 days. The other group will receive a shot every day for 14 days, too, but there is no medicine in it (called placebo).
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
- Double (Participant, Investigator)
盲法说明
While Care Provider and Outcomes Assessor were also blinded, it was considered a double-blind study.
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
- •Had a clinical diagnosis of relapsing-remitting multiple sclerosis (RRMS)
- •Had a relapse with onset ≤42 days prior to the Baseline Visit
- •Had started treatment with 3 to 5 days (inclusive, over a period of up to 7 days) of specific high dose corticosteroids within 28 days of the onset of the first relapse symptom
- •Had failed to obtain improvement of at least 1 point in one or more functions on the Function Systems Score (FSS) 14 days following their first dose of high dose corticosteroids
- •Has an Expanded Disability Index Scale (EDSS) score of 2.0 to 6.5 (inclusive) at the Baseline Visit
排除标准
- 未提供
研究组 & 干预措施
Acthar Gel
Participants receive Acthar Gel under the skin once a day for 14 consecutive days
干预措施: Acthar Gel (Drug)
Placebo
Participants receive Placebo under the skin once a day for 14 consecutive days
干预措施: Placebo (Drug)
结局指标
主要结局
Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42
时间窗: Baseline, Day 42
The EDSS is a 10-point assessment of neurological impairment/disability in multiple sclerosis (MS) patients, ranging from 0 (normal neurological examination) to 10 (death due to MS). EDSS is rated by a person who only collects outcome measures, and has no knowledge of the treatment received.
次要结局
未报告次要终点