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

Evotec

Status and phase: Completed; Phase 2

Conditions: Smoking Cessation

Treatments: Drug: Placebo; Drug: Placebo plus open label Nicotine Replacement; Drug: EVT 302; Drug: EVT 302 plus open label Nicotine replacement

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00738595

EVT 302/3009

EUDRACT No.: 2008-002472-99

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

EVT 302, 5 mg once Daily

Treatment:

Drug: EVT 302

2

Placebo Comparator group

Description:

Placebo once daily

Treatment:

Drug: Placebo

3

Experimental group

Description:

EVT 302 plus open label Nicotine replacement

Treatment:

Drug: EVT 302 plus open label Nicotine replacement

4

Active Comparator group

Description:

Placebo plus nicotine replacement therapy

Treatment:

Drug: Placebo plus open label Nicotine Replacement