Clinical trial NCT00738595: Phase II Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Keywords: Smoking Cessation
Lead sponsor: Evotec International GmbH
Sponsor class: INDUSTRY
Collaborators: name: PRA Health Sciences
name: Clinpharm International Management Holding GmbH
First posted: 2008-08-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: The four-week continuous quit rate over the last four weeks of treatment
timeFrame: Last 4 weeks of therapy
Secondary outcomes:
measure: 7 -week abstinence
timeFrame: 7 weeks post quit day
measure: 7-day point prevalence quit rate
timeFrame: weekly for 7 weeks
measure: Daily cigarettes smoked
timeFrame: Daily
measure: Change from baseline in the number of cigarettes smoked
timeFrame: Week 8
measure: Minnesota Nicotine Withdrawal Scale
timeFrame: Weekly
measure: Brief Questionnaire of Smoking Urges
timeFrame: Weekly
measure: Modified Cigarette Evaluation Questionnaire
timeFrame: Weekly
measure: Adverse Events
timeFrame: Weekly
measure: Laboratory investigations (Haematology & biochemistry)
timeFrame: Weekly
measure: ECGs
timeFrame: Weekly
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Evotec Study Site 2
city: Bochum
country: Germany
facility: Evotec Study Site 3
city: Chemnitz
country: Germany
facility: Evotec Study Site 8
city: Dresden
country: Germany
facility: Evotec Study Site 4
city: Frankfurt
country: Germany
facility: Evotec Study Site 5
city: Gorlitz
country: Germany
facility: Evotec Study Site 7
city: Leipzig
country: Germany
facility: Evotec Study Site 1
city: Magdeburg
country: Germany
facility: Evotec Study Site 6
city: Potsdam
country: Germany
facility: Evotec Study Site 9
Study officials:
affiliation: ClinPharm International, Leipzig, Germany
name: H D Stahl, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: