Trial | NCT00738595  Report issue

Title

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.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    nicotine sembragiline ...

  • Study Participants

    400
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.
Study Started
Aug 31
2008
Primary Completion
Mar 31
2009
Study Completion
May 31
2009
Last Update
May 29
2009
Estimate

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.

1 Experimental

EVT 302, 5 mg once Daily

2 Placebo Comparator

Placebo once daily

3 Experimental

EVT 302 plus open label Nicotine replacement

4 Active Comparator

Placebo plus nicotine replacement therapy

Criteria 

Inclusion Criteria:

Smoker of at least 10 cigarettes daily
Motivated to quit smoking
Reports at least one unsuccessful attempt to quit in the last 2 years
In generally good health
Provides written informed consent to participate in the sudy

Exclusion Criteria:

Pregnant or nursing females.
Women of child-bearing potential must agree to use acceptable contraceptive precautions (contraceptive pill and one barrier method)during the study and for 2-months thereafter
History of anaphylaxis
History of alcohol or drug abuse
History of or current significant medical or psychiatric disorder
History or presence of cataract or abnormality identified by slit lamp investigation
Use of other MAO inhibitors, pethidine, SSRIs, tricyclic antidepressants,nasal or oral decongestants or cold medicines containing ephedrine, pseudoephedrine or other sympathomimetics.
Any medicine contraindicated for use with MAO inhibitors.
Have or be a carrier of hepatitis B or c or HIV 1 or 2
Use of tobacco products other than cigarettes
Use of nicotine replacement therapy in the past month
Received an investigational drug in the past 30 days
Previous participation in a study with a MAO-B inhibitor
No Results Posted