ACTRN12618001341213终止1 期
A 15-Day, Single-blind, Placebo Controlled Food Safety and Tolerability Study of AXA3359 in Adult Subjects with Mild Traumatic Brain Injury (mTBI)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 35 Years（—）
- 性别
- All
入选标准
- •1. Males or females aged 18-35 years (inclusive)
- •2. Body Mass Index < 32 kg/m2
- •3. Confirmed medical diagnosis of concussion/mTBI from a study investigator within 24 hours or less of the injury event.
- •4. Otherwise in generally good health, and be nonsmokers and abstain from any alcohol use for the duration of the study.
- •6. A Brain Function Index (BFI) of <= 40 percentile
排除标准
- •1. Individuals with any clinically significant or unstable medical conditions, other than mTBI, requiring acute intervention.
- •2. Individuals with a concussion or a prior concussion or hospitalization for a head injury within 60 days
- •4. Any head trauma that is considered moderate” or severe” by the study investigator as measured by Glasgow Coma Scale (GCS) score of <13 within 24 hours of injury.
- •15. Receipt of an investigational drug or any investigational dietary supplement/food product (including, but not limited to creatine, Lacetyl carnitine, N-acetyl cysteine, any amino acids, protein drinks, fish oils, etc.), or participation in a trial of an investigational device within 1 month (or 5 half-lives), whichever is longer, before Screening.
研究者
相似试验
进行中（未招募）
1 期
This is a study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects with Moderately to Severely Active Crohn's Disease (CD)Subjects with moderately to severely active Crohn's diseaseMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2021-002869-18-BEAbbVie Deutschland GmbH & Co. KG265
进行中（未招募）
1 期
Clinical Trial to compare if seriously-ill adults with constipation due to narcotics have bowel movements sooner after injection with Methylnatrexone or placeboEUCTR2007-000854-30-BESalix Pharmaceuticals Inc254
进行中（未招募）
不适用
A study to evaluate the effect and safety of a 4 week treatment plan of Alirocumab in patients with high cholesterolPrimary HypercholesterolemiaMedDRA version: 17.0Level: LLTClassification code 10020604Term: HypercholesterolemiaSystem Organ Class: 100000004861EUCTR2013-002343-29-GBRegeneron Pharmaceuticals, Inc.803
进行中（未招募）
不适用
A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Tolerability of E5555, and its Effects on Markers of Intravascular Inflammation in Subjects with Coronary Artery Disease - E5555-G000-201Coronary Artery DiseaseMedDRA version: 8.1Level: PTClassification code 10011078EUCTR2005-006029-94-BEEisai Limited720
已完成
不适用
A Randomized, Double-Blind, Placebo-Controlled Study in Healthy Male Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of JNJ-26070109abdominal pain and heartburn10017943NL-OMON30044Janssen-Cilag82