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

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ClinicalTrials.gov Identifier: NCT00738595
Recruitment Status : Completed
First Posted : August 20, 2008
Last Update Posted : May 29, 2009
Sponsor:
Collaborators:
PRA Health Sciences
Clinpharm International Management Holding GmbH
Information provided by:
Evotec Neurosciences GmbH

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Drug: EVT 302 Drug: Placebo Drug: EVT 302 plus open label Nicotine replacement Drug: Placebo plus open label Nicotine Replacement Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
EVT 302, 5 mg once Daily
Drug: EVT 302
EVT 302 5 mg once daily

Placebo Comparator: 2
Placebo once daily
Drug: Placebo
Placebo to match EVT 302, 5 mg

Experimental: 3
EVT 302 plus open label Nicotine replacement
Drug: EVT 302 plus open label Nicotine replacement
Double-blind EVT 302 plus open label nicotine replacement

Active Comparator: 4
Placebo plus nicotine replacement therapy
Drug: Placebo plus open label Nicotine Replacement
Double-blind placebo plus open label Nicotine replacement patch 21 mg once daily.




Primary Outcome Measures :
  1. The four-week continuous quit rate over the last four weeks of treatment [ Time Frame: Last 4 weeks of therapy ]

Secondary Outcome Measures :
  1. 7 -week abstinence [ Time Frame: 7 weeks post quit day ]
  2. 7-day point prevalence quit rate [ Time Frame: weekly for 7 weeks ]
  3. Daily cigarettes smoked [ Time Frame: Daily ]
  4. Change from baseline in the number of cigarettes smoked [ Time Frame: Week 8 ]
  5. Minnesota Nicotine Withdrawal Scale [ Time Frame: Weekly ]
  6. Brief Questionnaire of Smoking Urges [ Time Frame: Weekly ]
  7. Modified Cigarette Evaluation Questionnaire [ Time Frame: Weekly ]
  8. Adverse Events [ Time Frame: Weekly ]
  9. Laboratory investigations (Haematology & biochemistry) [ Time Frame: Weekly ]
  10. ECGs [ Time Frame: Weekly ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00738595


Locations
Germany
Evotec Study Site 2
Berlin, Germany
Evotec Study Site 3
Bochum, Germany
Evotec Study Site 8
Chemnitz, Germany
Evotec Study Site 4
Dresden, Germany
Evotec Study Site 5
Frankfurt, Germany
Evotec Study Site 7
Gorlitz, Germany
Evotec Study Site 1
Leipzig, Germany
Evotec Study Site 6
Magdeburg, Germany
Evotec Study Site 9
Potsdam, Germany
Sponsors and Collaborators
Evotec Neurosciences GmbH
PRA Health Sciences
Clinpharm International Management Holding GmbH
Investigators
Principal Investigator: H D Stahl, MD, PhD ClinPharm International, Leipzig, Germany

Responsible Party: Dr S P Jones, VP Clinical Development, Evotec
ClinicalTrials.gov Identifier: NCT00738595     History of Changes
Other Study ID Numbers: EVT 302/3009
EUDRACT No.: 2008-002472-99
First Posted: August 20, 2008    Key Record Dates
Last Update Posted: May 29, 2009
Last Verified: May 2009

Keywords provided by Evotec Neurosciences GmbH:
Smoking Cessation

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action