Observational Study for Assessment of the Effect of Fampyra on the Manual Function of Persons With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Score of hand function tests
研究概览
简要总结
Multiple Sclerosis (MS) is the most common chronic neurological disease affecting young adults, with onset usually at age 20-40 years. Women are affected 3-4 times more than men. The disease is characterized by 2 main phenotypes: relapsing-remitting or progressive course.
Several immunotherapies were developed in the last 10-15 years for the long term management of the relapsing type of disease. Treatment with these drugs decreases disease activity though cannot cure it.
There are few treatments for targeting specific symptoms of MS, such as Provigil for the treatment of fatigue.
Regarding problems related to spasticity and related gait problems , which is stated by over 40 % of MS patients as their main complaint - present treatments include: non-pharmacological treatments such as physiotherapy, occupational therapy, hydrotherapy and pharmacological treatments such as Baclofen, Tizanidine and Botulinium toxin.
Fampyra (Fampridine) has recently been approved for use in patients with gait problems. This drug acts by blocking potassium ion channels and has been proven to improve walking in 35% of the patients after one month of treatment.
The effect of Fampyra on hand function in MS has yet to be studied. The aim of this research project is to assess the effect of treatment with Fampyra on manual function of patients with MS. The investigators hypothesize that through the same mechanism by which Fampyra improves ambulation it can also improve manual function.
MS patients visiting the MS center clinic at the Carmel Medical Center, with walking disabilities eligible to Fampyra treatment, that have also manual dysfunction, will be offered to participate in this study. Participants who agree to participate will be asked to sign a written informed consent. Information regarding their personal and family medical history will be collected via questionnaires. Medical staff will fill clinical questionnaires detailing patient clinical status prior to the study.
Patients will be followed up to 4 months after initiation of treatment with Fampyra. Compliance to treatment will be assessed by collection of the empty vials of the medication.
In each of the follow-up meetings evaluation of manual function, evaluation of ambulation and evaluation of general neurological function will be performed.
详细描述
BACKGROUND AND RATIONALE Multiple Sclerosis (MS) is the most common chronic neurological disease affecting young adults, with onset usually at age 20-40 years. Women are affected 3-4 times more than men. The disease is characterized by 2 main phenotypes: relapsing-remitting or progressive course.
Relapsing-remitting (RR) MS is the most common type of disease, affecting 60 to 85% of the patients. This form is characterized by relapses that lead to disability followed by periods of remission that may last for month to decades. During remission patients experience a significant improvement in their condition.
This form may transform into another disease type: Secondary progressive (SP) MS, in which there is a continuous deterioration in disability between relapses.
Primary-progressive (PP) MS- is characterized by a progressive decline in the patient condition with no remission.
MS is a complex multi-factorial disease, with underlying both genetic and environmental factors. Different populations have different susceptibility. It is characterized by the invasion of cells of the immune system cells into the central nervous system (CNS) provoking an inflammatory reaction against the myelin -producing cells- the olgodendrocytes as well as neurodegeneration. Myelin is an electrically insulating material that surrounds the axon and enhances the passage of electrical signals within the CNS.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females diagnosed with Multiple Sclerosis.
- •Walking disabilities and manual dysfunction.
- •Willing and able to give inform consent
排除标准
- •Additional CNS co-morbidity.
- •Renal failure.
- •MS relapse within previous 60 days.
- •History of epilepsy or epileptic brain activity on EEG or other conditions which could affect the interpretation of results.
- •Clinical problems that cause manual disability in addition to MS.
- •WITHDRAWAL CRITERIA
- •Participants who decide to withdraw from the study for any reason.
- •Technical problems in performing the tests.
结局指标
主要结局
Score of hand function tests
时间窗: 1,3,4 months after treatment initiation
Scores of hand function tests before treatment with Fampyra and at several timepoints after treatment initiation will be compared.
次要结局
- Improvement in daily function(1,3,4 months after treatment initiation)
- Correlation between improvement in manual function and ambulation(1,3,4 months after treatment initiation)
研究者
Ariel Miller
Director of Multiple Sclerosis & Brain Research Center
Carmel Medical Center