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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00738595
First Posted: August 20, 2008
Last Update Posted: May 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
PRA Health Sciences
Clinpharm International Management Holding GmbH
Information provided by:
Evotec Neurosciences GmbH
August 18, 2008
August 20, 2008
May 29, 2009
August 2008
March 2009   (Final data collection date for primary outcome measure)
The four-week continuous quit rate over the last four weeks of treatment [ Time Frame: Last 4 weeks of therapy ]
Same as current
Complete list of historical versions of study NCT00738595 on ClinicalTrials.gov Archive Site
  • 7 -week abstinence [ Time Frame: 7 weeks post quit day ]
  • 7-day point prevalence quit rate [ Time Frame: weekly for 7 weeks ]
  • Daily cigarettes smoked [ Time Frame: Daily ]
  • Change from baseline in the number of cigarettes smoked [ Time Frame: Week 8 ]
  • Minnesota Nicotine Withdrawal Scale [ Time Frame: Weekly ]
  • Brief Questionnaire of Smoking Urges [ Time Frame: Weekly ]
  • Modified Cigarette Evaluation Questionnaire [ Time Frame: Weekly ]
  • Adverse Events [ Time Frame: Weekly ]
  • Laboratory investigations (Haematology & biochemistry) [ Time Frame: Weekly ]
  • ECGs [ Time Frame: Weekly ]
Same as current
Not Provided
Not Provided
 
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.
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Smoking Cessation
  • Drug: EVT 302
    EVT 302 5 mg once daily
  • Drug: Placebo
    Placebo to match EVT 302, 5 mg
  • Drug: EVT 302 plus open label Nicotine replacement
    Double-blind EVT 302 plus open label nicotine replacement
  • Drug: Placebo plus open label Nicotine Replacement
    Double-blind placebo plus open label Nicotine replacement patch 21 mg once daily.
  • Experimental: 1
    EVT 302, 5 mg once Daily
    Intervention: Drug: EVT 302
  • Placebo Comparator: 2
    Placebo once daily
    Intervention: Drug: Placebo
  • Experimental: 3
    EVT 302 plus open label Nicotine replacement
    Intervention: Drug: EVT 302 plus open label Nicotine replacement
  • Active Comparator: 4
    Placebo plus nicotine replacement therapy
    Intervention: Drug: Placebo plus open label Nicotine Replacement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
May 2009
March 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00738595
EVT 302/3009
EUDRACT No.: 2008-002472-99
No
Not Provided
Not Provided
Dr S P Jones, VP Clinical Development, Evotec
Evotec Neurosciences GmbH
  • PRA Health Sciences
  • Clinpharm International Management Holding GmbH
Principal Investigator: H D Stahl, MD, PhD ClinPharm International, Leipzig, Germany
Evotec Neurosciences GmbH
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP