Carisbamate Treatment for Alcohol Dependence

Carisbamate 治疗酒精依赖

• 批准号: 8455440
• 负责人: Thomas Frederick Newton
• 金额: $ 10.69万
• 依托单位: MEDICATIONS DISCOVERY TEXAS, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-05-01 至 2013-09-24
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8455440
• 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

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）：虽然 FDA 并未专门批准用于该适应症，但托吡酯是治疗酒精依赖的最有效的药物之一。然而，托吡酯很少用于治疗酒精依赖，因为它具有显着的副作用，包括嗜睡、头晕和认知障碍，需要逐渐调整剂量。许多患者在托吡酯有助于减少饮酒之前就停止服用托吡酯。我们已将卡里斯巴酯确定为治疗酒精依赖的新候选疗法，因为它具有托吡酯的作用机制，但缺乏托吡酯令人不安的副作用。此外，与其他抗惊厥药不同，卡里斯氨酯和托吡酯都可以减少啮齿动物的酒精摄入量。 Carisbamate 作为癫痫治疗方法已经过广泛测试，安全且耐受性良好。 Memedication Discovery Texas, Inc 和贝勒医学院（小型企业和学术申请人）正在与 SK Biopharmaceuticals（专利持有者）合作，开发和商业化 carisbamate 作为酒精依赖的治疗方法。我们第一阶段的具体目标是进行人体实验室研究，以确定在使用 carisbamate 治疗期间服用轻度中毒剂量酒精的安全性（n = 20，两组，每组 10 人）。里程碑 1 是研究参与者能够耐受每天服用 carisbamate 剂量（300 mg bid）四天而没有明显副作用，里程碑 2 是 carisbamate 没有过度加剧在 carisbamate 治疗期间作为挑战给予的轻度中毒剂量酒精的影响。我们的 II 期具体目标是完成一项双盲、随机安慰剂对照门诊临床试验（n=72，两组，每组 36 人）。该试验将评估 carisbamate 在减少接受医疗治疗的酒精依赖患者中重度饮酒天数百分比方面的功效。如果这些试验证明有效，德克萨斯州药物发现公司将寻求外部资金来支持 FDA 批准 carisbamate 作为酒精依赖治疗所需的临床开发。