Study detail
RecruitingPhase 3
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.
Summary
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.
Description
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Detailed criteria
Inclusion Criteria: * Male or female, aged 18 to 65 (inclusive) Exclusion Criteria: * Unable to comply with study procedures. * Medically inappropriate for study participation in the opinion of the investigator.
Interventions
- DrugAXS-05 (dextromethorphan-bupropion)
AXS-05 tablets, taken twice daily for 12 weeks.
- Drug