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

Phase 2

Completed

• Conditions: Smoking Cessation
• Interventions: Drug: Placebo; Drug: EVT 302; Drug: EVT 302 plus open label Nicotine replacement; Drug: Placebo plus open label Nicotine Replacement

• Registration Number: NCT00738595
• Lead Sponsor: Evotec Neurosciences GmbH

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-18
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-20
• Primary Completion: 2009-03
• Status Verified: 2009-05
• Study Completion: 2009-05
• Last Update Submitted: 2009-05-28
• Last Update Posted: 2009-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo once daily
1	EVT 302	EVT 302, 5 mg once Daily
3	EVT 302 plus open label Nicotine replacement	EVT 302 plus open label Nicotine replacement
4	Placebo plus open label Nicotine Replacement	Placebo plus nicotine replacement therapy

Primary Outcome Measures

Name	Time	Method
The four-week continuous quit rate over the last four weeks of treatment	Last 4 weeks of therapy

Secondary Outcome Measures

Name	Time	Method
7 -week abstinence	7 weeks post quit day
7-day point prevalence quit rate	weekly for 7 weeks
Daily cigarettes smoked	Daily
Change from baseline in the number of cigarettes smoked	Week 8
Minnesota Nicotine Withdrawal Scale	Weekly
Brief Questionnaire of Smoking Urges	Weekly
Modified Cigarette Evaluation Questionnaire	Weekly
Adverse Events	Weekly
Laboratory investigations (Haematology & biochemistry)	Weekly
ECGs	Weekly

Trial Locations

Locations (9)

Evotec Study Site 3; 🇩🇪 Bochum, Germany

Evotec Study Site 9; 🇩🇪 Potsdam, Germany

Evotec Study Site 1; 🇩🇪 Leipzig, Germany

Evotec Study Site 2; 🇩🇪 Berlin, Germany

Evotec Study Site 6; 🇩🇪 Magdeburg, Germany

Evotec Study Site 8; 🇩🇪 Chemnitz, Germany

Evotec Study Site 4; 🇩🇪 Dresden, Germany

Evotec Study Site 5; 🇩🇪 Frankfurt, Germany

Evotec Study Site 7; 🇩🇪 Gorlitz, Germany