EUCTR2005-002209-22-GB进行中（未招募）1 期
A randomised, placebo-controlled, rising-dose crossover study to evaluate the effectiveness of modafinil in the management of fatigue in fibromyalgia - Modafinil and fibromyalgia
niversity Hospitals of Leicester NHS Trust0 个研究点目标入组 24 人开始时间: 2005年7月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Written Informed Consent
- •Widespread body pain
- •A positive tender point count of at least 11 out of 18 points on digital palpation
- •Daily fatigue of greater than 4 points on the Fatigue Scale
- •Fatigue for greater than 24 hours following minimal activity
- •Age 18 to 65 years inclusive
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •History of inflammatory disease or neoplasm
- •Major psychological disorders known to affect sleep as assessed by the PRIME-MD scale.
- •Breast feeding mothers
- •Hypertension
- •Patients with a score of less than 24 out of 30 on the Mini-Mental State Exam.
- •Any clinically significant, uncontrolled medical or psychiatric conditions (treated or untreated)
- •History of left ventricular hypertrophy, cor pulmonale or mitral valve prolapse
- •Lactose intolerance
- •Known sensitivity to other constituents of modafinil tablet ie maize starch, magnesium silicate, croscarmellose sodium, Povidone K90, Talc or magnesium stearate.
- •Patient is taking anticonvulsants, anticoagulants, melatonin, St John’s Wort, methylphenidate, amphetamines, pemoline, zolpidem, monoamine oxidase inhibitors, barbiturates, benzodiazepines, lithium or antipsychotic drugs.
- •Has a significant deviation from normal in the physical examination.
- •Has any disorder that may interfere with drug absorption, distribution, metabolism or excretion (including gastro-intestinal surgery).
- •Any other sleep disorder including obstructive sleep apnoea, narcolepsy or periodic leg movement syndrome.
- •Previous use of Modafinil (Provigil).
- •Clinical history of heart, kidney or liver disease, heart attack, diseases of the CNS, alcoholism or drug dependence.
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