Amantadine and Transcranial Magnetic Stimulation for Treating Fatigue in Multiple Sclerosis: Phase III Study, Controlled, Randomized, Crossed Over and Double Blind.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 4
- 主要终点
- To assess the fatigue severity
研究概览
简要总结
Multiple Sclerosis (MS) is the most frequent cause of non-traumatic disability in people under 55 years of age. Fatigue is the most frequent and disabling symptom in the disease, and for which there is no effective treatment. Among the proposed drugs, amantadine is the one that could be most useful, although up to now it has not been adequately demonstrated due to a lack of sufficiently powerful and methodologically appropriate clinical trials. Transcranial magnetic stimulation (TMS) has recently been proposed as a useful treatment for fatigue in MS in preliminary studies.
详细描述
Multiple Sclerosis (MS) is the most frequent cause of non-traumatic disability in people under 55 years of age. Fatigue is the most frequent and disabling symptom in the disease, and for which there is no effective treatment. Among the proposed drugs, amantadine is the one that could be most useful, although up to now it has not been adequately demonstrated due to a lack of sufficiently powerful and methodologically appropriate clinical trials. Transcranial magnetic stimulation (TMS) has recently been proposed as a useful treatment for fatigue in MS in preliminary studies.
The main objective of the study is to evaluate the change in the severity of fatigue in MS patients undergoing treatment with amantadine, TMS and both in combination, compared to placebo. A randomized, placebo-controlled, crossover, double-blind clinical trial will be conducted. As secondary objectives, changes in cognition, depression and quality of life will be evaluated. For all this, the reference scales adequately validated for each of the objectives will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, 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
- •Expanded Disability Status Scale mark 1.5 - 4.5
- •Fatigue Severity Scale > 4
- •Beck Depression Inventory < 30
- •No relapse for, at least, three month prior to screening
- •Drug washout period = 4 weeks for any fatigue aimed drug
- •Patient capable to sign the informed consent
排除标准
- •Fatigue causing disease other than multiple sclerosis:
- •sleep apnea
- •other autoimmune disease that could be explain the fatigue.
- •endocrine autoimmune disease if the blood test is not in range in the last 6 month.
- •patient with diagnosis of chronic fatigue
- •Patient with high blood pressure out of range or decompensated heart failure or New York Heart Association (NYHA) 3-
- •Secondary Epilepsy or neuropathic chronic pain which requires continuous treatment.
- •Contraindication for trial treatment:
- •Some kind of magnetic metal.
- •Epilepsy antecedents.
- •Any drugs that could decrease the seizure threshold
- •Amantadine sensitivity
- •Cardiopathy disease, severe kidney failure, Angle-closure glaucoma
- •Breastfeeding, pregnancy, or pregnancy planning phase in the next year. Of childbearing potential and willing to use an acceptable method of contraception during the study period.
- •Patient with a terminal disease with no more than one year life expectancy.
- •Patient has been treated for a maligned disease in the past three years.
- •A scheduled surgery in the course of the trials.
- •Any condition that a member of research team consider could affect to participation/follow up patient.
- •Alcoholic o toxics condition in the last year.
- •Major mental disorders
- •Poor communication skills or poor cognitive condition.
- •Other trial participation in the previous 4 month.
- •Use a chronic drug that could interfere in the clinical outcome.
研究组 & 干预措施
Amantadine
干预措施: Amantadine Hydrochloride 100 mg (milligrams) Oral Capsule (Drug)
Placebo
干预措施: Amantadine Hydrochloride 100 mg (milligrams) Oral Capsule (Drug)
TMS
干预措施: Transcranial Magnetic Stimulation (Device)
TMS sham
干预措施: Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
To assess the fatigue severity
时间窗: 6 weeks after starting treatment
To compare the effect of TMS and amantadine alone or in combination therapy compared with placebo on fatigue determined using the Modified Fatigue Impact Scale (Total MFIS score: Range from 0 to 84, from minimal to severe fatigue).
次要结局
- To assess the depression condition(6 weeks after starting treatment)
- Cost-effectivity assessment(6 weeks after starting treatment)
- To assess the cognitive condition(6 weeks after starting treatment)
- Safety assessment(6 months after randomization)
- To assess the quality of life(6 weeks after starting treatment)
研究者
Jorge Matías-Guiu
Principal Investigator
Hospital San Carlos, Madrid