IRCT20230125057221N1招募中3 期
Assessment of the efficacy of lisdexamfetamine on fatigue in patients with multiple sclerosis: A randomized, double-blind, placebo-controlled study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 45 years（—）
- 性别
- All
入选标准
- •Definitive diagnosis of MS based on 2017 McDonald criteria
- •Age 18 to 45 years
- •Informed and written consent of the patient
- •Total score obtained from MFIS greater than 33
- •Not changing the type or dose of DMT in the last three months
排除标准
- •Pregnancy or breastfeeding
- •Allergy to the drug or formulation ingredients
- •Severe renal failure (ClCr < 30 ml/min/1.73m2)
- •moderate to severe liver failure (Child Pugh B, C)
- •history of attack or receiving pulse dose of corticosteroid in the last one month or during the study
- •Changing the used medication during the study
- •Abuse of alcohol and drugs such as opium or psychoactive agents
- •simultaneous use or last two weeks use of amantadine, modafinil, methylphenidate, dexamphetamine
- •suffering from any untreated thyroid disorder (TSH outside the normal range)
- •Vitamin D level less than 20 ng/ml
- •A patient with anemia (hemoglobin less than 14 g/dL in men or less than 12 g/dL in women)
- •Patients who suffer from severe fatigue and need symptomatic treatment due to ethical considerations
- •History of cardiovascular or cerebrovascular disease such as IHD, ACS, heart failure, any cerebral ischemia and bleeding, and uncontrolled blood pressure (SBP =160 or DBP =100)
- •Concurrently suffering from any anxiety disorder, severe depression or psychosis for which they are receiving pharmacotherapy
- •History or simultaneous suffering from epilepsy
- •Taking monoamine oxidase inhibitors in the last 14 days
研究者
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