NCT04996056撤回2 期
An Open-Label, Randomized Pilot Study Comparing the Safety of a Single Dose of TNX-1300 to Usual Care (UC) Alone for the Treatment of Signs and Symptoms of Acute Cocaine Intoxication in Male Emergency Department (ED) Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Incidence of Treatment Emergent Adverse Events, Adverse Events of Special Interests, and Adverse Drug Reactions
研究概览
简要总结
An Open-Label, Randomized Pilot Study Comparing the Safety of a Single Dose of TNX-1300 to Usual Care (UC) Alone for the Treatment of Signs and Symptoms of Acute Cocaine Intoxication in Male Emergency Department (ED) Subjects
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
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject is male (sex assigned at birth).
- •Subject is 18-50 years of age.
- •Subject has the capacity to provide voluntary written informed consent.
- •At Screening, subject presents with a SIS total score of ≥6 and a score >1 on at least 1 of the 3 cardiovascular items (HR, systolic and diastolic BP).
- •At Screening, subject presents with cardiac symptoms not present prior to cocaine intoxication, with or without behavioral symptoms.
- •Subject has a positive urine drug screen test at Screening to confirm cocaine use and detect polysubstance abuse (subject may test positive for cannabinoids or opiates).
- •Subject is a suitable candidate for investigational treatment based on the opinion of the investigator.
排除标准
- •Subject who has been admitted to the ED involuntarily.
- •Subject who participated in this clinical study previously.
- •Subject received naloxone (Narcan) within 3 hours prior to informed consent.
- •Subject tests positive for 3,4-Methylenedioxymethamphetamine (MDMA) or amphetamine at Screening.
- •Subject has a prior or current clinically significant untreated cardiac condition. Untreated hypertension may be allowed if not considered severe or life threatening.
- •Subject incurred or is likely to incur a myocardial infarction or other life-threatening severe event or has acute ECG changes indicative of acute coronary syndrome according to investigator judgment.
- •Subject has a clinically significant or unstable medical illness, condition, or disorder that would be anticipated to potentially compromise subject safety or adversely affect the evaluation of clinical outcome parameters.
- •Subject requires physical restraints due to physiological and/or behavioral symptoms.
- •Participation in another investigational drug study (current or within 30 days of Screening).
研究组 & 干预措施
TNX-1300
Experimental
TNX-1300 Intravenous injection 200 mg once over 2 mins
干预措施: TNX-1300 (Drug)
Usual Care
Other
Usual Care per the Emergency Department protocol for treating Cocaine Intoxication
干预措施: Usual Care (Other)
结局指标
主要结局
Incidence of Treatment Emergent Adverse Events, Adverse Events of Special Interests, and Adverse Drug Reactions
时间窗: Baseline to 12 Hours
Incidence of Treatment Emergent Adverse Events, Adverse Events of Special Interests, and Adverse Drug Reactions
次要结局
- Reduction of cardiovascular and other signs and symptoms associated with acute cocaine intoxication identified at Baseline on the Stimulant Intoxication Scale (SIS)(Baseline to 6 Hours)
- Reduction of circulating cocaine, cocaethylene, and EME levels after 15, 60, 120, 240, and 360 minutes in the TNX-1300 arm compared to Baseline(Baseline to 6 Hours)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults.HealthyNCT01490788Tonix Pharmaceuticals, Inc.30
已完成
1 期
A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects.HealthyNCT04322266Hanmi Pharmaceutical Company Limited61
已完成
1 期
A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination of HCP1904 and Co-Administration of RLD2001-2 and RLD2006 Tablets in Healthy Subjects.HealthyNCT05191563Hanmi Pharmaceutical Company Limited56
已完成
2 期
A Six Week Topical Cream Study for Subjects With Ichthyosis VulgarisIchthyosis VulgarisNCT03173547Crown Laboratories, Inc.80
已完成
1 期
Study of NVN1000 Topical Gel and Topical Gel Vehicle in the Treatment of Moderate to Severe Acne VulgarisAcne VulgarisAcneNCT01556698Novan, Inc.70