临床试验/NCT07766655

NCT07766655招募中3 期

A Randomized, Double-Blind, Placebo and Active-Controlled Trial to Evaluate the Efficacy and Safety of AXS-05 for Smoking Cessation in Adults

Axsome Therapeutics, Inc.17 个研究点分布在 1 个国家目标入组 705 人开始时间: 2026年8月27日最近更新: 2026年9月8日

适应症

干预措施

试验速览

阶段: 3 期
状态: 招募中
发起方: Axsome Therapeutics, Inc.
入组人数: 705
试验地点: 17
主要终点: 4-Week Continuous Smoking Abstinence Rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a Phase 3, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group trial to evaluate the efficacy and safety of AXS-05 compared to placebo and bupropion for smoking cessation in adults.

详细描述

Eligible subjects will be randomized in a 1:1:1 ratio to receive AXS-05, bupropion, or placebo for 12 weeks, followed by an 18-week follow-up period.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Male or female, aged 18 to 65 (inclusive)

排除标准

•Unable to comply with study procedures.
•Medically inappropriate for study participation in the opinion of the investigator.

研究组 & 干预措施

AXS-05

Experimental

Up to 12 weeks

干预措施: AXS-05 (dextromethorphan-bupropion) (Drug)

Placebo

Placebo Comparator

Up to 12 weeks

干预措施: Placebo (Drug)

Bupropion

Experimental

Up to 12 weeks

干预措施: Bupropion (Drug)

结局指标

主要结局

4-Week Continuous Smoking Abstinence Rate

时间窗: Weeks 9 to 12

次要结局

未报告次要终点

研究者

发起方

Axsome Therapeutics, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (17)

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