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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT No.: 2008-002472-99 |
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| Name | Class |
|---|---|
| PRA Health Sciences | INDUSTRY |
| Clinpharm International Management Holding GmbH | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | EVT 302, 5 mg once Daily |
|
| 2 | Placebo Comparator | Placebo once daily |
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| 3 | Experimental | EVT 302 plus open label Nicotine replacement |
|
| 4 | Active Comparator | Placebo plus nicotine replacement therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVT 302 | Drug | EVT 302 5 mg once daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The four-week continuous quit rate over the last four weeks of treatment | Last 4 weeks of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 7 -week abstinence | 7 weeks post quit day | |
| 7-day point prevalence quit rate | weekly for 7 weeks | |
| Daily cigarettes smoked |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| H D Stahl, MD, PhD | ClinPharm International, Leipzig, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evotec Study Site 2 | Berlin | Germany | ||||
| Evotec Study Site 3 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37230961 | Derived | Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6. |
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| Drug |
Placebo to match EVT 302, 5 mg |
|
| EVT 302 plus open label Nicotine replacement | Drug | Double-blind EVT 302 plus open label nicotine replacement |
|
| Placebo plus open label Nicotine Replacement | Drug | Double-blind placebo plus open label Nicotine replacement patch 21 mg once daily. |
|
| 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 |
| Bochum |
| Germany |
| Evotec Study Site 8 | Chemnitz | Germany |
| Evotec Study Site 4 | Dresden | Germany |
| Evotec Study Site 5 | Frankfurt | Germany |
| Evotec Study Site 7 | Görlitz | Germany |
| Evotec Study Site 1 | Leipzig | Germany |
| Evotec Study Site 6 | Magdeburg | Germany |
| Evotec Study Site 9 | Potsdam | Germany |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C000614721 | sembragiline |
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