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

Smoking Cessation Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738595
• Other study ID #: EVT 302/3009
• Secondary ID: EUDRACT No.: 200
• Status: Completed
• Phase: Phase 2
• First received: August 18, 2008
• Last updated: May 28, 2009
• Start date: August 2008
• Est. completion date: May 2009

Study information

• Verified date: May 2009
• Source: Evotec Neurosciences GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• EVT 302
EVT 302 5 mg once daily
• Placebo
Placebo to match EVT 302, 5 mg
• EVT 302 plus open label Nicotine replacement
Double-blind EVT 302 plus open label nicotine replacement
• Placebo plus open label Nicotine Replacement
Double-blind placebo plus open label Nicotine replacement patch 21 mg once daily.

Locations

Country	Name	City	State
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

Sponsors (3)

Lead Sponsor	Collaborator
Evotec Neurosciences GmbH	Clinpharm International Management Holding GmbH, PRA Health Sciences

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The four-week continuous quit rate over the last four weeks of treatment		Last 4 weeks of therapy	No
Secondary	7 -week abstinence		7 weeks post quit day	No
Secondary	7-day point prevalence quit rate		weekly for 7 weeks	No
Secondary	Daily cigarettes smoked		Daily	No
Secondary	Change from baseline in the number of cigarettes smoked		Week 8	No
Secondary	Minnesota Nicotine Withdrawal Scale		Weekly	No
Secondary	Brief Questionnaire of Smoking Urges		Weekly	No
Secondary	Modified Cigarette Evaluation Questionnaire		Weekly	No
Secondary	Adverse Events		Weekly	Yes
Secondary	Laboratory investigations (Haematology & biochemistry)		Weekly	Yes
Secondary	ECGs		Weekly	Yes