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

This study has been completed.
Sponsor:
Collaborators:
PRA Health Sciences
Clinpharm International Management Holding GmbH
Information provided by:
Evotec Neurosciences GmbH
ClinicalTrials.gov Identifier:
NCT00738595
First received: August 18, 2008
Last updated: May 28, 2009
Last verified: May 2009
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Evotec Neurosciences GmbH:

Primary Outcome Measures:
  • The four-week continuous quit rate over the last four weeks of treatment [ Time Frame: Last 4 weeks of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 7 -week abstinence [ Time Frame: 7 weeks post quit day ] [ Designated as safety issue: No ]
  • 7-day point prevalence quit rate [ Time Frame: weekly for 7 weeks ] [ Designated as safety issue: No ]
  • Daily cigarettes smoked [ Time Frame: Daily ] [ Designated as safety issue: No ]
  • Change from baseline in the number of cigarettes smoked [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Minnesota Nicotine Withdrawal Scale [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Brief Questionnaire of Smoking Urges [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Modified Cigarette Evaluation Questionnaire [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
  • Laboratory investigations (Haematology & biochemistry) [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
  • ECGs [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: August 2008
Study Completion Date: May 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: August 18, 2008
Last Updated: May 28, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014