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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00738595

Enrollment

400

Registered

2008-08-20

Start date

2008-08-31

Completion date

2009-05-31

Last updated

2009-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

Smoking Cessation

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.

Interventions

DRUGEVT 302

EVT 302 5 mg once daily

DRUGPlacebo

Placebo to match EVT 302, 5 mg

DRUGEVT 302 plus open label Nicotine replacement

Double-blind EVT 302 plus open label nicotine replacement

DRUGPlacebo plus open label Nicotine Replacement

Double-blind placebo plus open label Nicotine replacement patch 21 mg once daily.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
7 -week abstinence	7 weeks post quit day
Modified Cigarette Evaluation Questionnaire	Weekly
Adverse Events	Weekly
Laboratory investigations (Haematology & biochemistry)	Weekly
ECGs	Weekly
Brief Questionnaire of Smoking Urges	Weekly

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026