A Phase IIa Multicenter Double Blind Study to Evaluate the Efficacy and Safety of Low Doses of Oral NT-KO-003 for the Treatment of Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 17
- 主要终点
- Efficacy of NT-KO-003 in patients with relapsing remitting MS patients
研究概览
简要总结
The aim of the study is to assess the efficacy and safety of NT-KO-003 in the treatment of relapsing remitting multiple sclerosis, comparing two doses versus placebo.
详细描述
This is a Phase IIa study, double blind, placebo Controlled, Multicenter Study that will involve up to 99 patients with relapsing remitting multiple sclerosis.
After signing the informed consent form, subjects will be randomized to three treatments arms: placebo, NT-KO-003 low dose or NT-KO-003 high dose. Treatment will continue daily during 6 months. A MRI and a clinical evaluation will be performed monthly. Safety will be assessed during the 6 months treatment and until 15 days after the finalization of the treatment.
Patients will be allowed to continue in the same arm of the study, in a blinded way, until the study finalizes as optional extension treatment. Patient will sign the Extension Informed Consent and a MRI will be performed for those patients still in treatment after 12 months of the inclusion in the core study (visit 0).
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 55 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
NT-KO-003 low dose
干预措施: NT-KO-003 (Drug)
NT-KO-003 high dose
干预措施: NT-KO-003 (Drug)
Placebo
干预措施: NT-KO-003 (Drug)
结局指标
主要结局
Efficacy of NT-KO-003 in patients with relapsing remitting MS patients
时间窗: 6 months
efficacy will be measured as the cumulative number of new lesions observed in all MRIs, with exception of baseline
次要结局
- Efficacy of NT-KO-003 in relapsing remitting MS patients(6 months)
- Clinical efficacy of NT-KO-003 in relapsing remitting MS patients(6 months)
- Safety of NT-KO-003 in patients with relapsing remitting MS patients(six and a half months)
