NCT00738595

Phase II Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation.

Phase II Multicentre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation, Effect on it Own and in Combination With Open Label Nicotine Replacement Therapy.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Evotec Neurosciences GmbH · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the efficacy of EVT 302, a potent and selective inhibitor of Monoamine Oxidase - B, in improving quit rates in chronic cigarette smokers who are motivated to quit smoking. EVT 302 will be compared to placebo both with and without open label nicotine replacement therapy.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
DRUG	EVT 302	EVT 302 5 mg once daily
DRUG	Placebo	Placebo to match EVT 302, 5 mg
DRUG	EVT 302 plus open label Nicotine replacement	Double-blind EVT 302 plus open label nicotine replacement
DRUG	Placebo plus open label Nicotine Replacement	Double-blind placebo plus open label Nicotine replacement patch 21 mg once daily.

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-03-01
• Completion: 2009-05-01
• First posted: 2008-08-20
• Last updated: 2009-05-29

Locations

9 sites across 1 country: Germany