NIAAA Clinical Trials

NIAAA 临床试验

基本信息

批准号：
8948534
负责人：
JANET RANSOM
金额：
$ 339.38万
依托单位：
FAST-TRACK DRUGS AND BIOLOGICS, LLC
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-23 至 2016-03-22
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8948534
关键词：
Accountability Adult Advertising Agreement Alcohol dependence Alcohols Amendment Annual Reports Authorization documentation Award Biological Blood Blood specimen Budgets Calibration Case Report Form Certificate of Confidentiality Clinic Clinical Clinical Data Clinical Practice Guideline Clinical Trials Clinical Trials Data Monitoring Committees Code Collaborations Collection Computer software Confidentiality Conflict (Psychology)Conflict of Interest Consent Consent Forms Contractor Contracts Data Data Collection Data Coordinating Center Data Sources Development Dictionary Disclosure Documentation Dose Educational Curriculum Electronics Enrollment Ensure Epilepsy Equipment Ethnic Origin Event Exclusion Criteria Extramural Activities Financial Disclosures Freezing Funding Generic Drugs Good Clinical Practice Grant Guidelines Health Human Human Resources Hydrolysis Individual Industry Information Systems Informed Consent Institutional Review Boards Instruction Internet Job Description Label Laboratories Laboratory Study Libraries Licensing Location Logistics Manuals Manufacturer Name Medical Mission Molecular Target Monitor Names National Institute on Alcohol Abuse and Alcoholism Needles Outcome Assessment Patients Pharmaceutical Preparations Pharmacologic Substance Phase Physicians Placebo Control Plasma Population Positioning Attribute Postherpetic neuralgia Preclinical Drug Evaluation Preparation Principal Investigator Printing Procedures Process Prodrugs Protocols documentation Quality Control Questionnaires Race Radio Randomized Reading Records Recruitment Activity Reporting Research Personnel Resolution Restless Legs Syndrome Rights Safety Sample Size Sampling Schedule Secure Security Selection Criteria Serious Adverse Event Services Shipping Ships Site Slide Specimen Study Subject Substance abuse problem Syringes System Tablets Teleconferences Telephone Testing Time Training Translations Tube United States Food and Drug Administration Update Urine Visit Withdrawal Work absorption alcohol use disorder analog base clinical research site cost data exchange data management design drug distribution electronic data experience gabapentin gamma-Aminobutyric Acid meetings member operation payment phosphatidylethanol pre-clinical programs protocol violation quality assurance response sample collection screening statistics symposium

项目摘要

Medications development is a high priority program at National Institute on Alcohol Abuse and Alcoholism (NIAAA). Currently, only 3 medications are approved by the Food and Drug Administration (FDA) for the treatment of alcohol dependence. These medications have demonstrated small to moderate effect sizes in clinical trials and do not work for everyone. Thus, the search for new molecular targets and more efficacious drugs is critical. The creation of the NIAAA Clinical Investigations Group (NCIG) program was recommended by the NIAAA Extramural Advisory Board on Medications Development, a subcommittee of Council, February 7- 8, 2005 and subsequently approved by the full NIAAA National Advisory Council, June 2005. The Council recognized the urgent need for a rapid and efficient mechanism to conduct Proof-of- Concept (POC) trials of promising compounds to treat alcohol dependence. To carry out this mission, a contract mechanism was authorized to fund the NCIG program, which includes a Data Coordinating Center and a network of experienced clinical trial sites. The NIAAA has a mission to develop safe and effective medications to treat alcohol use disorder (AUD) in various populations. Part of the mission involves translation of the preclinical to human laboratory studies to ultimately clinical trials. Gabapentin is a GABA analog that was originally developed to treat epilepsy (Neurontin®) and more recently has been approved for the treatment of postherpetic neuralgia (Neurontin®, Gralise®). Gabapentin enacarbil is an actively transported prodrug of gabapentin that undergoes rapid post absorption hydrolysis to gabapentin that was designed to produce dose proportional gabapentin blood level exposure. Gabapentin enacarbil Extended Release Tablets (Horizant®) is approved for the treatment of moderate to severe primary restless leg syndrome in adults and management of postherpetic neuralgia in adults. II. SCOPE The purpose of this task order is to perform the planning and preparation of study materials for the NCIG 006 study which involves conducting start-up activities, randomization and study conduct for at least 50 subjects in a randomized placebo controlled proof-of-concept clinical trial of gabapentin enacarbil for patients with alcohol use disorder.

药物开发是美国国家酒精滥用与酒精中毒研究所（NIAAA）的高优先计划。目前，食品药品监督管理局（FDA）仅批准3种药物来治疗酒精依赖。这些药物在临床试验中表现出很小至中度的有效尺寸，并且不适合所有人。这是至关重要的。 NIAAA AAA药物外咨询委员会推荐了NIAAA临床研究小组（NCIG）计划的创建计划，2005年2月7日至8日，理事会小组委员会，并由完整的NIAAA国家咨询委员会批准，随后由NIAAA国家咨询委员会批准了2005年6月，该理事会认可了一项迫切需要进行的证明，并进行了证明（prounde and Complient）。依赖。为了执行此任务，合同机制被授权为NCIG计划提供资金，该计划包括数据协调中心和经验丰富的临床试验地点网络。 NIAA的使命是开发安全有效的药物来治疗各种人群中的酒精使用障碍（AUD）。该任务的一部分涉及将临床前向人类实验室研究转换为最终临床试验。 Gabapentin是GABA类似物，是Gabapentin Enacarbil是一种积极运输的Gabapentin前药，在水解后遭受了加巴喷丁的快速进行，旨在产生比例剂量的加巴喷丁素血液水平暴露。 Gabapentin Enacarbil扩展释放片（Horizant®）被批准用于治疗成年人中中度至重度原发性不安腿综合征，并治疗成人后静态神经元的治疗。 ii。该任务顺序的目的范围是为NCIG 006研究进行研究材料的计划和准备，该研究涉及在随机安慰剂控制的Gabapentin Enacarbil的随机安慰剂对概念证明临床试验中，对酒精使用障碍的患者进行至少50名受试者的研究。