Carisbamate Treatment for Alcohol Dependence

Carisbamate 治疗酒精依赖

基本信息

批准号：
8735477
负责人：
Thomas Frederick Newton
金额：
$ 75.23万
依托单位：
MEDICATIONS DISCOVERY TEXAS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-05-01 至 2017-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8735477
关键词：
Adverse effects Adverse event Alcohol consumption Alcohol dependence Alcoholic Intoxication Alcohols Anticonvulsants Biological Products Businesses Clinical Clinical Trials Data Development Dizziness Dose Double-Blind Method Drowsiness Drug Interactions Ensure Epilepsy Evaluation FDA approved Funding Glutamates Goals Heavy Drinking Human Impaired cognition Industry Laboratories Laboratory Study Legal patent Marketing Medical Medicine Outcome Measure Outpatients Participant Patients Pharmaceutical Preparations Phase Phase III Clinical Trials Placebo Control Placebos Randomized Research Risk Rodent Safety Sample Size Signal Transduction Structure Symptoms Testing Texas Titrations Woman alcohol effect base college craving drinking gamma-Aminobutyric Acid interest medication compliance men neurotransmission primary outcome public health relevance secondary outcome topiramate treatment effect volunteer

项目摘要

DESCRIPTION (provided by applicant): Though not specifically FDA-approved for this indication, topiramate is among the most effective medication treatments for alcohol dependence. Topiramate is rarely used to treat alcohol dependence, however, because it has prominent side effects including somnolence, dizziness, and cognitive disturbances that require gradual dose titration. Many patients stop taking topiramate before it helps them to reduce drinking. We have identified carisbamate as a new candidate treatment for alcohol dependence because it shares topiramate's mechanism of action but lacks topiramate's troubling side effects. Further, unlike other anticonvulsants, both carisbamate and topiramate reduce alcohol intake in rodents. Carisbamate has been tested extensively as a treatment for epilepsy and is safe and well tolerated. Medication Discovery Texas, Inc and Baylor College of Medicine (the Small Business and academic applicants) are collaborating with SK Biopharmaceuticals (the patent holder) to develop and commercialize carisbamate as a treatment for alcohol dependence. Our Phase I Specific Aim is to conduct a human laboratory study to determine the safety profile of administering a mildly intoxicating dose of alcohol during treatment with carisbamate (n=20, two groups of 10). Milestone 1 is that study participants are able to tolerate carisbamate dosing (300 mg bid) daily for four days without significant side effects and milestone 2 is that carisbamate did not excessively exacerbate the effects of a mildly intoxicating dose of alcohol given as a challenge during carisbamate treatment. Our Phase II Specific Aim is to complete a double-blind, randomized placebo-controlled outpatient clinical trial (n=72, two groups of 36). The trial will evaluate the efficacy of carisbamate for reducing percent heavy drinking days among treatment-seeking alcohol-dependent patients receiving medical management. If these trials demonstrate efficacy, Medication Discovery Texas will seek outside funding to support the clinical development needed for FDA approval of carisbamate as a treatment for alcohol dependence.

描述（由申请人提供）：尽管未针对此指示进行FDA批准，但托吡酯是酒精依赖性最有效的药物治疗方法之一。但是，托吡酯很少用于治疗酒精依赖性，因为它具有明显的副作用，包括需要慢性剂量滴定的脾气暴躁，头晕和认知障碍。许多患者在帮助他们减少饮酒之前停止服用托吡酯。我们已经确定卡利斯巴纳特是对酒精依赖的新候选治疗方法，因为它具有托吡酯的作用机理，但缺乏托吡酯的令人不安的副作用。此外，与其他抗惊厥药不同，carisbamate和topiramate都会减少啮齿动物的酒精摄入量。卡利斯氨酸已被广泛测试作为癫痫的治疗方法，并且安全且耐受性良好。德克萨斯州的药物发现，Inc和贝勒医学院（小型企业和学术申请人）正在与SK Biopharmaceuticals（专利持有人）合作开发和商业化Carisbamate作为酒精依赖的治疗方法。我们的I阶段特定目的是进行人类实验室研究，以确定在用咖啡氨酸酯治疗期间使用轻度醉酒的酒精的安全性（n = 20，两组10组）。里程碑1的是，研究参与者能够每天四天耐受carisbamate剂量（300 mg BID），而没有明显的副作用，而里程碑2的是，在甲状腺果治疗期间，carisbamate并没有过度加剧作为挑战性饮酒剂量的挑战。我们的II期特定目的是完成双盲，随机的安慰剂对照门诊临床试验（n = 72，两组36组）。该试验将评估卡利体酯对降低接受医疗管理的依赖酒精依赖的患者的大量饮酒天数的疗效。如果这些试验表现出功效，则得克萨斯州的药物发现将寻求外部资金，以支持Carisbamate批准Carisbamate所需的临床发展作为酒精依赖的治疗方法。