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

Sponsor
Evotec Neurosciences GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT00738595
Collaborator
PRA Health Sciences (Industry), Clinpharm International Management Holding GmbH (Other)
400
Enrollment
9
Locations
4
Arms
9
Duration (Months)
44.4
Patients Per Site
5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: EVT 302
  • Drug: Placebo
  • Drug: EVT 302 plus open label Nicotine replacement
  • Drug: Placebo plus open label Nicotine Replacement
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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.
Study Start Date :
Aug 1, 2008
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
May 1, 2009

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. The four-week continuous quit rate over the last four weeks of treatment [Last 4 weeks of therapy]

Secondary Outcome Measures

  1. 7 -week abstinence [7 weeks post quit day]

  2. 7-day point prevalence quit rate [weekly for 7 weeks]

  3. Daily cigarettes smoked [Daily]

  4. Change from baseline in the number of cigarettes smoked [Week 8]

  5. Minnesota Nicotine Withdrawal Scale [Weekly]

  6. Brief Questionnaire of Smoking Urges [Weekly]

  7. Modified Cigarette Evaluation Questionnaire [Weekly]

  8. Adverse Events [Weekly]

  9. Laboratory investigations (Haematology & biochemistry) [Weekly]

  10. ECGs [Weekly]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Evotec Study Site 2 Berlin Germany
2 Evotec Study Site 3 Bochum Germany
3 Evotec Study Site 8 Chemnitz Germany
4 Evotec Study Site 4 Dresden Germany
5 Evotec Study Site 5 Frankfurt Germany
6 Evotec Study Site 7 Gorlitz Germany
7 Evotec Study Site 1 Leipzig Germany
8 Evotec Study Site 6 Magdeburg Germany
9 Evotec Study Site 9 Potsdam Germany

Sponsors and Collaborators

  • Evotec Neurosciences GmbH
  • PRA Health Sciences
  • Clinpharm International Management Holding GmbH

Investigators

  • Principal Investigator: H D Stahl, MD, PhD, ClinPharm International, Leipzig, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00738595
Other Study ID Numbers:
  • EVT 302/3009
  • EUDRACT No.: 2008-002472-99
First Posted:
Aug 20, 2008
Last Update Posted:
May 29, 2009
Last Verified:
May 1, 2009
Keywords provided by , ,
Smoking Cessation
Additional relevant MeSH terms:
Nicotine

Study Results

No Results Posted as of May 29, 2009