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 II

MedlinePlus related topics:

Smoking Smoking Cessation

ChemIDplus related topics:

Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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.

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
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental EVT 302, 5 mg once Daily	Drug: EVT 302 EVT 302 5 mg once daily
2: Placebo Comparator Placebo once daily	Drug: Placebo Placebo to match EVT 302, 5 mg
3: Experimental EVT 302 plus open label Nicotine replacement	Drug: EVT 302 plus open label Nicotine replacement Double-blind EVT 302 plus open label nicotine replacement
4: Active Comparator 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

Contacts


Contact: Jo Renold	+44 1189181091	renoldjo@praintl.com

Contact: Stephen P Jones, PhD	+44 1235441423	stephen.jones@evotec.com

Locations


Germany
	Evotec Study Site 1	Recruiting
	Leipzig, Germany
	Evotec Study Site 2	Recruiting
	Berlin, Germany
	Evotec Study Site 3	Recruiting
	Bochum, Germany
	Evotec Study Site 4	Recruiting
	Dresden, Germany
	Evotec Study Site 9	Not yet recruiting
	Potsdam, Germany
	Evotec Study Site 6	Recruiting
	Magdeburg, Germany
	Evotec Study Site 7	Recruiting
	Gorlitz, Germany
	Evotec Study Site 8	Recruiting
	Chemnitz, Germany
	Evotec Study Site 5	Recruiting
	Frankfurt, 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

Responsible Party:	Evotec ( Dr S P Jones, VP Clinical Development )
Study ID Numbers:	EVT 302/3009, EUDRACT No.: 2008-002472-99
First Received:	August 18, 2008
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00738595
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Evotec Neurosciences GmbH:

Smoking Cessation

Study placed in the following topic categories:

Nicotine polacrilex

Smoking

Nicotine

Additional relevant MeSH terms:

Neurotransmitter Agents

Cholinergic Agonists

Molecular Mechanisms of Pharmacological Action

Nicotinic Agonists

Physiological Effects of Drugs

Central Nervous System Stimulants

Cholinergic Agents

Pharmacologic Actions

Habits

Autonomic Agents

Therapeutic Uses

Ganglionic Stimulants

Peripheral Nervous System Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 15, 2008

Sponsors and Collaborators:	Evotec Neurosciences GmbH PRA International Clinpharm International Management Holding GmbH
Information provided by:	Evotec Neurosciences GmbH
ClinicalTrials.gov Identifier:	NCT00738595