CTRI/2010/091/000043已完成3 期
Evaluation of efficacy and safety of armodafinil versus Modafinil in the treatment of patients with excessive daytime sleepiness associated with narcolepsy: a randomized, open label, comparative, multi-centre trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
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
入选标准
- •1. Male or female patients aged between 18 and 65 years.
- •2. Patients diagnosed with excessive sleepiness associated with narcolepsy.
- •3. Patient willing to give their informed consent.
排除标准
- •1. Pregnant or lactating women and women of childbearing potential who are not on acceptable birth control methods.
- •2. Women using steroidal contraceptives.
- •3. Patients who have probable diagnosis of a current sleep disorder other than narcolepsy in opinion of the investigator.
- •4. Patients having any significant uncontrolled medical or psychiatric disorder, other than narcolepsy, that can cause excessive sleepiness.
- •5. Patients consuming > 600 mg/day of caffeine.
- •6. Patients having history of alcohol, narcotic or drug abuse.
- •7. Patients using any of the drugs such as sodium oxybate, lithium, St. John's Wort, methylphenidate, amphetamines, pemoline, antipsychotics, benzodiazepines, zolpidem, zopiclone, MAO inhibitors, anticoagulants, anticonvulsants.
- •8. Patients with severe renal and hepatic impairment.
- •9. Patients with known hypersensitivity to armodafinil and modafinil or its inactive ingredients.
- •10. Has a serum creatinine of > 1.5 x upper limit of normal.
- •11. Has thyroid stimulating hormone value outside the normal range.
- •12. Patients having risk of cardiovascular events.
- •13. Patients having participated in another clinical trial in proceeding one month period.
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