Early N-Acetyl Cysteine Treatment for Head Trauma-induced Anosmia
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Olfactory Function
研究概览
简要总结
This study will compare administration of N-Acetyl Cysteine (NAC) versus placebo for the treatment of olfactory loss due to head injury. The hypothesis is that treatment with NAC acutely after head injury will result in improved olfactory function
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Admitted to Ryder Trauma Center for observation acutely following head injury (i.e. concussion), with documented hyposmia or anosmia by University of Pennsylvania Smell Identification Test (SIT).
- •Male or female, aged 18 years or older
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Ability to take oral medication and be willing to adhere to the NAC regimen
- •For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of NAC administration
排除标准
- •Severe trauma requiring ongoing inpatient treatment beyond 48 hours
- •Pregnancy (based on urine screening) or lactation
- •Known allergic reactions to components of NAC, such as Mucomyst
- •Currently taking nitrates such as nitroglycerine and/or isosorbide regularly
- •Currently taking azathioprine (Imuran) or cyclophosphamide (Cytoxan)
- •Known diagnosis of cystinuria (renal condition in which cysteine supplement should be avoided)
- •Febrile illness within 1 week
- •Treatment with another investigational drug or other intervention within 3 months
- •Active sinonasal disease by imaging and/or nasal exam, i.e. rhinosinusitis, nasal polyps
- •Adults unable to consent
- •Prisoners, employees or subordinates
- •Individuals who are not yet adults (infants, children, teenagers). This population is excluded because efficacy has not yet been established in adults.
研究组 & 干预措施
NAC Group
NAC group will be administered orally as a 4 gram loading dose, followed by 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days
干预措施: N Acetyl Cysteine (Drug)
Placebo Group
Placebo group will be administered orally as a 4 gram loading dose, followed by 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Olfactory Function
时间窗: 4 months
Olfactory function will be measured using the University of Pennsylvania Smell Identification Test (UPSIT). The UPSIT is a self-administered 40-item test involving microencapsulated (scratch-and-sniff) odors with a forced-choice design. The total score ranges from 0-40 with the higher score indicating better olfactory function.
次要结局
- Quality of Life Questionnaire(4 months)
研究者
Roy R. Casiano
Professor
University of Miami