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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 18, 2008

Last Updated Date

January 12, 2009

Start Date ^†

August 2008

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00738595 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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.

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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

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

Condition ^†

Smoking Cessation

Intervention ^†

Drug: EVT 302
Drug: Placebo
Drug: EVT 302 plus open label Nicotine replacement
Drug: Placebo plus open label Nicotine Replacement

Study Arms / Comparison Groups

Experimental: EVT 302, 5 mg once Daily
Placebo Comparator: Placebo once daily
Experimental: EVT 302 plus open label Nicotine replacement
Active Comparator: Placebo plus nicotine replacement therapy

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

400

Estimated Completion Date

June 2009

Estimated Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Germany

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00738595

Responsible Party

Dr S P Jones, VP Clinical Development, Evotec

Secondary IDs ^††

EUDRACT No.: 2008-002472-99

Study Sponsor ^†

Evotec Neurosciences GmbH

Collaborators ^††

PRA International
Clinpharm International Management Holding GmbH

Investigators ^†

Principal Investigator:

H D Stahl, MD, PhD

ClinPharm International, Leipzig, Germany

Information Provided By

Evotec Neurosciences GmbH

Verification Date

December 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.