Status:
COMPLETED
Phase II Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation.
Lead Sponsor:
Evotec Neurosciences GmbH
Collaborating Sponsors:
PRA Health Sciences
Clinpharm International Management Holding GmbH
Conditions:
Smoking Cessation
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2009
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00738595
Start Date
August 1 2008
End Date
May 1 2009
Last Update
May 29 2009
Active Locations (9)
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1
Evotec Study Site 2
Berlin, Germany
2
Evotec Study Site 3
Bochum, Germany
3
Evotec Study Site 8
Chemnitz, Germany
4
Evotec Study Site 4
Dresden, Germany