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    Summary
    EudraCT Number:2007-006236-63
    Sponsor's Protocol Code Number:EVT 302/3011
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-11-27
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2007-006236-63
    A.3Full title of the trial
    A double-blind, randomized, placebo- and NRT-controlled Phase II study to assess the effects of EVT 302 alone and in combination with NRT on craving and withdrawal in healthy male smokers deprived of cigarettes
    A.4.1Sponsor's protocol code numberEVT 302/3011
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEvotec Neurosciences GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameEVT 302
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive nameEVT 302
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name NiQuitin Clear 21 mg
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Consumer Healthcare GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNikotin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number114
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Smoking cessation.

    Assessment of the effect of EVT 302 alone or in combination with a nicotine replacement therapy (NRT) on craving and withdrawal in smokers after short-term deprivation of cigarettes.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10053325
    E.1.2Term Smoking cessation therapy
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of a single dose of EVT 302 on
    craving and withdrawal in smokers after short-term
    deprivation of cigarettes compared with placebo.
    E.2.2Secondary objectives of the trial
    • To assess the influence of a combination of EVT 302 with nicotine replacement therapy (NRT) versus the effect of EVT 302 alone and of NRT alone on craving and withdrawal in smokers
    • To assess the influence of EVT 302 alone and EVT 302 in combination with NRT, compared with NRT alone and placebo on cognition and reaction
    time
    • To assess the influence of EVT 302 alone, compared with placebo on mood and emotion
    • To assess the pharmacodynamic effect of EVT 302 on monoamine oxidase (MAO)-B
    platelet inhibition
    • To assess plasma concentrations of EVT 302 before and at the end of the smoking cessation
    period
    • To assess biomarkers for cigarette consumption
    • To assess the safety and tolerability of EVT 302 alone or in combination with NRT in smokers Hierarchy of testing for differences: Primary: EVT 302 versus Placebo Secondary: EVT 302 versus EVT 302 plus NRT EVT 302 versus NRT NRT versus Placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male subjects between 18 and 55 years of age, inclusive
    2. Body mass index (BMI) in the range of 18 kg/m2 and 30 kg/m2, inclusive, and
    minimum weight of 50 kg
    3. In good general health and is expected by the Investigator to complete the clinical
    study as designed
    4. Negative urine drug screen for cannabis, opiates, cocaine metabolites,
    amphetamines, barbiturates and benzodiazepines including ethanol at screening
    and baseline
    5. Have adequate hearing, vision, and language skills to follow the study conditions
    6. Readiness to comply with tyramine-restricted food intake
    7. Smoking of ≥17 and ≤34 cigarettes (i.e. between 1 and 2 packs) per day for the
    past year and have not tried to quit smoking in the 3 months prior to screening
    8. Subjects should smoke their preferred cigarette brand during the study and must
    not change it during the entire study participation
    9. Subjects are willing and, in the Investigator’s opinion, able to quit for about
    12 hours in each of three subsequent study periods
    10. Subjects are expected to experience craving symptoms after smoking cessation
    as known from previous attempts to quit smoking
    11. Breath CO at least between 15 ppm and 20 ppm and cotinine in saliva at least 250 ng/mL at screening
    12. Liver function test (LFT) results (Alanine aminotransferase [ALT], Aspartate
    aminotransferase [AST], Alkaline phosphatase [ALP], total bilirubin and Gammaglutamyl transferase [GGT]) not above 1.5 times the upper
    normal limit (UNL) at screening visit and at re-assessment during the study.
    13. Have voluntarily provided informed consent and signed an informed consent form
    E.4Principal exclusion criteria
    1. Participation in another clinical study with an investigational medicinal product
    (IMP) within the 60 days before screening
    2. Inability to understand the protocol requirements, instructions and study-related
    restrictions, the nature, scope, and possible consequences of the study
    3. Unlikely to comply with the protocol requirements, instructions and study-related
    restrictions; e.g., uncooperative attitude, inability to return for follow-up visits, and
    improbability of completing the study
    4. Evidence of active significant psychiatric or neurological disease or dependency
    other than cigarettes
    5. Are known to have or are a carrier of the hepatitis B surface antigen (HBsAg),
    hepatitis C virus (HCV) antibody, has a positive result to the human
    immunodeficiency virus-1 and/or 2 (HIV-1 and/or HIV-2) antibodies
    6. Subject is expected to be able to cease smoking easily for days without
    experiencing craving and smoking urges
    7. Known hypersensitivity to MAO inhibitors or any substance that is contained in the
    study formulations
    8. Known allergy to plasters or NRT patches
    9. Previous participation in another study with EVT 302
    10. Are currently receiving treatment for smoking cessation
    11. Are currently using tobacco products other than cigarettes (e.g. pipes, cigars,
    snuff or chewing tobacco)
    12. Require treatment with any medication
    13. Blood or plasma donation of more than 500 mL in the 3 months before allocation
    or of 50 mL in the 2 weeks before the first dosing
    14. Subject with a clinically relevant abnormal 12-lead ECG recording or QTcB/F
    >430 ms
    15. Use of a prescription medicine during within 14 days or 5 half-lives, whichever is
    the longer, of the start of dosing, or use of an over-the-counter medication during
    the 7 days before the study, including herbal remedies, but excluding paracetamol
    and vitamin supplements (provided intake does not exceed the daily
    recommended allowance)
    16. Subjects must not be planning to father a child or donate sperm, during the study
    and 3 months after the end of the study. Acceptable methods of contraception
    comprise barrier contraception and a medically accepted contraceptive method for
    the female partner (intra-uterine device with spermicide, hormonal contraceptive
    since at least 2 month)
    17. Subject is the Investigator or any sub-investigator, research assistant, pharmacist,
    study coordinator, other staff or relative thereof directly involved in the conduct of
    the study
    18. Presence or history of severe adverse reaction to any drug
    19. Daily consumption of more than 5 cups of tea or coffee, or more than 1.0 litre of
    xanthine-containing drinks
    20. Treatment in the previous 3 months with any drug known to have a well-defined
    potential for toxicity to a major organ
    21. Vulnerable subjects (e.g. persons kept in detention)
    22. Recent myocardial infarction, instable or worsening angina pectoris, prince
    metal angina, severe arrhythmias, recent stroke.
    23. Creatinine clearance (CLR) calculated according to the formula by
    Modification of Diet in Renal Disease (MDRD) of <80 mL/min and that in the
    opinion of the Investigator indicates renal impairment
    CLR will be calculated from serum creatinine values at Screening (Scr), using
    the following formula:
    Ccr = 170 x Scr-0.999 x age-0.176 x SUN-0.170 x Alb+0.318
    age [years], Scr = serum creatinine, SUN = serum urea nitrogen, Alb = serum
    albumin.
    E.5 End points
    E.5.1Primary end point(s)
    The degree of nicotine craving and urging assessed by the Questionnaire of
    Smoking Urges (QSU-Brief) craving score
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-11-28
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