Randomized, Double-Blind, Placebo-Controlled Study of Dexmethylphenidate Hydrochloride, (d-MPH) in the Treatment of Fatigue in Sarcoidosis Subjects.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Improvement of fatigue.
研究概览
简要总结
Patients diagnosed with chronic sarcoidosis with fatigue for more than 6 months. Sarcoidosis and its treatment can greatly affect your quality of life. Many patients suffer from fatigue (feeling tired), lack of focus and concentration, in ability to organize their daily activities, and memory loss. These commonly reported symptoms often get in the way of everyday life.
详细描述
This is to be a double blind, randomized trial with cross over of 12 patients with chronic sarcoidosis on stable systemic therapy. Patients will be screened for fatigue using a modified SNAP and Facit-F scores. Patients will be in the study for 20 weeks. Objective of study: To determine the effect of dexmethylphenidate hydrochloride, (d-MPH)(Focalin) on fatigue in Sarcoidosis. The is a common complaint in sarcoidosis, related to the chronic inflammatory nature of the disease. It may also related to therapy for the disease.
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
- Quadruple (Participant, Care Provider, 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
- •Diagnosis of sarcoidosis using standard criteria
- •Disease for more than one year
- •Complain of fatigue which has been present for more than six months.
- •Over 18 years of age
排除标准
- •Pregnancy
- •Change in therapy for sarcoidosis in prior three months
- •history of ventricular arrythmias
- •Patients with a history of anxiety disorder, glaucoma, motor ties or a family history of Tourette's syndrome.
- •Patients who are currently receiving or have received monoamine oxidase inhibitors within 14 days prior to study entry.
结局指标
主要结局
Improvement of fatigue.
时间窗: 30 weeks
次要结局
- Improvement of pulmonary status(30 weeks)
- Safety of treatment(30 weeks)