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.

药物开发是国家酒精滥用和酒精中毒研究所 (NIAAA) 的一项高度优先计划，目前，只有 3 种药物获得美国食品和药物管理局 (FDA) 批准用于治疗酒精依赖，这些药物已显示出小到中度的效果。 NIAAA 校外咨询委员会建议建立 NIAAA 临床研究小组 (NCIG) 计划。药物开发，理事会的一个小组委员会，2005 年 2 月 7-8 日，随后于 2005 年 6 月得到 NIAAA 国家咨询委员会全体批准。理事会认识到迫切需要一个快速有效的机制来进行概念验证 (POC)为了完成这项任务，NCIG 项目获得了资助，其中包括一个数据协调中心和一个由经验丰富的临床试验站点组成的网络。 NIAAA 的使命是开发安全有效的药物来治疗不同人群的酒精使用障碍 (AUD)，其中一部分涉及将临床前研究转化为人体实验室研究，最终进行临床试验。治疗癫痫 (Neurontin®)，最近已被批准用于治疗带状疱疹后神经痛 (Neurontin®、Gralise®)，加巴喷丁依那卡必 (Gabapentin enacabil) 是一种主动转运的前药。加巴喷丁吸收后快速水解为加巴喷丁，旨在产生比例剂量的加巴喷丁依那卡必缓释片（Horizant®），被批准用于治疗成人中度至重度原发性不宁腿综合征和治疗带状疱疹后神经痛。 II. 范围该任务订单的目的是为 NCIG 006 研究制定学习材料，其中涉及启动。在加巴喷丁依那卡比治疗酒精使用障碍患者的随机安慰剂对照概念验证临床试验中，对至少 50 名受试者进行活动、随机化和研究实施。