A multicentric, randomized, comparative clinical trial of Armodafinil versus Modafinil in patients with excessive sleepiness associated with shift work sleep disorder (SWSD).
试验速览
- 阶段
- 3 期
- 发起方
- 试验地点
- 22
- 主要终点
- 1)Responder rate 2)Improvement in grades based on Stanford Sleepiness Score 3)Compliance of therapy 4)Patients and physicians overall assessment for Efficacy and tolerability
研究概览
简要总结
This multicentric, double blind, randomized comparative clinical trial is proposed to evaluate efficacy and safety of Armodafinil versus Modafinil in Indian patients with excessive sleepiness associated with shift work sleep disorder (SWSD). After satisfing exclusion and inclusion criteria, patients will be randomized to receive either Armodafinil or Modafinil. The duration of this study is of 12 weeks and patients will be evaluated at baseline and after 4, 8 and 12 weeks. Efficacy Variables are i)Responder rate: Percent of subject showing at least 2 grades of improvement based on Stanford Sleepiness Score ii)Improvement in grades based on Stanford Sleepiness Score iii)Compliance of therapy iv)Patients and physicians overall assessment for Efficacy and tolerability. Biochemical Parameters and ECG will be done baseline and after completion of therapy. Any adverse event if any will be recorded.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
入选标准
- •Male, non-pregnant female and female taking suitable precautions for contraception between the ages of 18 and 60 years worked each month at least five night shifts for 12 hours or less, with 6 hours or more worked between 10 p.m. and 8 a.m. and at least three shifts occurring consecutively.2)Patients with Shift work sleep disorder diagnosed by following (The international classification of sleep disorder) criteria:A.The patient has a primary complaint of insomnia or excessive sleepiness.B.The primary complaint is temporally associated with a work period (usually night work) that occurs during the habitual sleep phase.C.No medical or mental disorder accounts for the symptoms.D.The symptoms do not meet criteria for any other sleep disorder producing insomnia or excessive sleepiness (e.g., time-zone change [jet lag] syndrome).Minimal Criteria: A plus B.3)Willing to give written informed consent & willing to comply with trial protocol.
排除标准
- •Patients < 18 and > 60 years of age.2)Patients with significant liver/kidney/heart diseases.3)Presence of clinically significant, uncontrolled psychiatric or medical condition.4)Patients with known history of hypersensitivity to formulation.5)Patients operating an automobile or hazardous machinery.6)Pregnant and lactating mother.7)Female of reproductive age and willing to become pregnant.8)Female of reproductive age using steroidal contraceptives.9)Patients with Alcohol or drug abuse.10)Caffeine consumption averaging more than 600 mg/day within 1 week of baseline11)Use of other concomitant medications which inhibit, induce or metabolized by CYP450 viz: Carbamazepine, phenobarbital, rifampin, ketoconazole, erythromycin, cyclosporine, ethinyl estradiol, triazolam, phenytoin, diazepam, and propranolol, omeprazole and clomipramine etc.12)Patients using sedative or CNS acting drugs or medication liable to affect outcome of the study (e.g. antihistamines, selective serotonin reuptake inhibitors, tricyclic antidepressants, lithium, antipsychotics, anticonvulsants, monoamine oxidase inhibitor, benzodiazepines, psychostimulants and anticoagulants).13)Patients without the ability to comply with the study protocol and complete the study in the judgment of the investigator.
结局指标
主要结局
1)Responder rate 2)Improvement in grades based on Stanford Sleepiness Score 3)Compliance of therapy 4)Patients and physicians overall assessment for Efficacy and tolerability
时间窗: Baseline, 4, 8 and 12 weeks
次要结局
未报告次要终点