Phase II Study to Evaluate the Effectiveness of EVT 302 in Smoking Cessation. - Full Text View

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:

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Nicotine tartrate Nicotine polacrilex

U.S. FDA Resources

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

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 International

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:

Smoking
Habits
Nicotine
Nicotine polacrilex
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
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013