Effect of Pulsed ACTH add-on Therapy to Weekly Avonex on Remyelination and Neuroregeneration in Patients With Relapsing Remitting Multiple Sclerosis. A 1-year Placebo-controlled, Double-blinded, Randomized Follow-up Study
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To define the effect of add-on pulsed IM ACTH vs. placebo to IFNβ-1a I.M. on a voxel-wise MTR dynamic mapping of the lesions and NABT in patients with RRMS
研究概览
简要总结
The purpose of this study is to evaluate whether the use of ACTH in addition to Avonex is effective in the treatment of relapsing remitting multiple sclerosis.
详细描述
Multiple sclerosis (MS) is a chronic, immune-mediated disease of the central nervous system (CNS). It is a complex, multi-factorial disease that includes inflammatory and neurodegenerative processes manifesting both focally in the form of lesions and diffusely in otherwise normal-appearing brain tissue. Recent data shows that ACTH can have beneficial effects on specific neurodegenerative diseases and it may have superior neuroprotective effects. Adding a regimen of ACTH to standard Avonex treatment may provide neuroprotection and promote remyelination.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with MS according to McDonald criteria
- •Age 18-65
- •Have a RR disease course
- •Have EDSS scores 0-5.5
- •Have a disease duration <20 years
- •Sub-optimal response to Interferon beta-1a I.M. (Avonex®) while being on therapy for at least 6 months defined as:
- •presence of a documented relapse within the last 12 months
- •or the presence of at least one enhancing T1 Gd lesion on an MRI performed within previous 3 months
- •Signed informed consent
- •Normal kidney functioning (creatinine clearance >59)
- •None of the exclusion criteria
排除标准
- •Presence of relapse or steroid treatment within 60 days prior to study enrollment
- •Presence of neutralizing antibodies to IFNβ-1a I.M. prior to study enrollment
- •Presence of optic neuritis within less than 6 months prior to study enrollment
- •Diagnosis of osteoporosis (T score ≥2.5 SD)
- •Women who are pregnant, lactating or of childbearing age who do not consent to approved contraceptive use during the study.
- •Abnormal blood tests, performed during the screening visit including: hepatitis B or hepatitis C, ALT or AST greater than two times the upper limit of normal, abnormal glucose fasting levels or already known diabetes
- •History of depression while on IFNβ-1a I.M.
研究组 & 干预措施
Placebo
Patients receive placebo only
干预措施: Saline (Drug)
Adrenocorticotropin hormone
Patients receive the hormone
干预措施: repository corticotropin injection (Drug)
结局指标
主要结局
To define the effect of add-on pulsed IM ACTH vs. placebo to IFNβ-1a I.M. on a voxel-wise MTR dynamic mapping of the lesions and NABT in patients with RRMS
时间窗: 1 year
Effect of ACTH in MRI
次要结局
- To define the effect of add-on pulsed IM ACTH vs. placebo to IFNβ-1a I.M. in RRMS on anterior optic pathway pathology, as measured by OCT and LCLA in patients with RRMS.(1 year)
研究者
Robert Zivadinov, MD, PhD
Director, Buffalo Neuroimaging Analysis Center, Professor
University at Buffalo