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

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.

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: EVT 302; Drug: Placebo; Drug: EVT 302 plus open label Nicotine replacement; Drug: Placebo plus open label Nicotine Replacement

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Evotec Study Site 2
  • Bochum, Germany
    • Evotec Study Site 3
  • Chemnitz, Germany
    • Evotec Study Site 8
  • Dresden, Germany
    • Evotec Study Site 4
  • Frankfurt, Germany
    • Evotec Study Site 5
  • Gorlitz, Germany
    • Evotec Study Site 7
  • Leipzig, Germany
    • Evotec Study Site 1
  • Magdeburg, Germany
    • Evotec Study Site 6
  • Potsdam, Germany
    • Evotec Study Site 9

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The four-week continuous quit rate over the last four weeks of treatment	Last 4 weeks of therapy

Secondary Outcome Measures

Outcome Measure	Time Frame
7 -week abstinence	7 weeks post quit day
7-day point prevalence quit rate	weekly for 7 weeks
Daily cigarettes smoked	Daily
Change from baseline in the number of cigarettes smoked	Week 8
Minnesota Nicotine Withdrawal Scale	Weekly
Brief Questionnaire of Smoking Urges	Weekly
Modified Cigarette Evaluation Questionnaire	Weekly
Adverse Events	Weekly
Laboratory investigations (Haematology & biochemistry)	Weekly
ECGs	Weekly

Collaborators and Investigators

• Sponsor: Evotec Neurosciences GmbH
• Collaborators: PRA Health Sciences; Clinpharm International Management Holding GmbH
• Investigators: Principal Investigator: H D Stahl, MD, PhD, ClinPharm International, Leipzig, Germany

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (ACTUAL): March 1, 2009
• Study Completion (ACTUAL): May 1, 2009

Study Registration Dates

• First Submitted: August 18, 2008
• First Submitted That Met QC Criteria: August 19, 2008
• First Posted (ESTIMATE): August 20, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): May 29, 2009
• Last Update Submitted That Met QC Criteria: May 28, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: Smoking Cessation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: EVT 302/3009; EUDRACT No.: 2008-002472-99