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    Summary
    EudraCT Number:2008-002472-99
    Sponsor's Protocol Code Number:EVT302/3009
    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:2008-06-06
    Trial results View 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 number2008-002472-99
    A.3Full title of the trial
    A phase II multicenter, randomised, double-blind, parallel group, placebo-controlled, study to evaluate the effectiveness of EVT 302 in smoking cessation, effect on its own and in combination with open label nicotine replacement
    A.4.1Sponsor's protocol code numberEVT302/3009
    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.3.9.1CAS number 676479-06-4
    D.3.9.2Current sponsor codeEVT 302
    D.3.9.3Other descriptive name(S)-N-{1-[4-(3-Fluoro-benzyloxy)-phenyl] -5-oxo-pyrrolidin-3-yl}-acetamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number5 mg
    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
    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.3.1Product nameNiQuitin 21 mg transdermal patch
    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 INNNICOTINE
    D.3.9.1CAS number 54-11-5
    D.3.9.3Other descriptive name(S)-3-(1-Methylpyrrolidin-2-yl)pyridine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number114 mg
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Male or female subjects who are chronic smokers, but motivated to quit smoking will be recruited.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    .To evaluate the efficacy and safety of EVT 302 compared with placebo as an aid to smoking cessation in chronic cigarette smokers.
    E.2.2Secondary objectives of the trial
    .To assess the efficacy of EVT 302 when combined with NRT.
    .To assess the efficacy of EVT 302 compared with placebo in reducing the symptoms of nicotine withdrawal.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, 18 to 70 years of age.
    2. Body Mass Index (BMI) > 18 and < 31 kg/m2.
    3. Agrees to abstain from taking any prescription or non-prescription drugs (except as authorised by the Investigator) for seven days prior to the first dose of study drug through the end of the study. Exceptions include multivitamins, oral contraceptives, and topical agents.
    4. Smoker of at least 10 cigarettes daily and no more than 1 month of continued abstinence in the last 12 months.
    5. Motivated to quit smoking.
    6. Reports at least one unsuccessful attempt to quit smoking in the last 2 years.
    7. Agrees to attend study visits and complete required assessments.
    8. In generally good health based on medical history and clinically acceptable results on the following assessments: physical examination, vital signs, clinical chemistry (liver function test (LFT) results for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT) at screening not above 1.5 times the upper limit of normal (ULN)), haematology, urinalysis, and 12 lead electrocardiogram (ECG). Seated systolic blood pressure must be >90 mmHg and ≤150 mmHg and seated diastolic blood pressure must be >50 mmHg and ≤95 mmHg at screening and baseline.
    9. Able and agrees to complete diary and questionnaires, communicate effectively with study personnel and be considered reliable, willing and cooperative in terms of compliance with the protocol requirements.
    10. Voluntarily gives written informed consent to participate in the study.
    E.4Principal exclusion criteria
    1. Female subjects currently pregnant and/or nursing. Non-pregnancy of women with childbearing potential will be confirmed by serum pregnancy tests conducted at screening. Women without childbearing potential are those hysterectomised, sterile or post menopausal with amenorrhoea of least one year duration. Women of childbearing potential will agree to use an acceptable form of birth control (contraceptive pill and barrier contraception - partner using condom or subject using spermicide, diaphragm or contraceptive sponge) during the study and for at least 2 months after completing the study. Male subjects must agree to use either double-barrier contraception or their partner must use the contraceptive pill during the study and for at least 2 months after completing the study.
    2. Has a history of anaphylaxis with clinical signs, a documented immunological hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug. A history of rash after penicillin intake without hospitalisation is acceptable.
    3. Has a history or presence of abuse of alcohol, licit or illicit drug substances within the last 12 months (abuse of alcohol defined as intake of more than 15 units of alcohol weekly for men and 10 units weekly for women where 1 unit corresponds to 285 mL beer, 125 mL wine and 25 mL spirit, respectively), or a positive drug screen for drugs of abuse (including tetrahydrocannabinol for marijuana and breath test for alcohol).
    4. History of or current significant medical (e.g. cardiovascular, hepatic, endocrine, bronchopulmonary and neurological, but not exclusively) or psychiatric disorder (including schizophrenia, seasonal affective and other mood disorders, history of or current tendency for suicidal thoughts and suicidal attempts) that may pose a risk to the subject in this study or adversely interact with study measures or the subject’s ability to participate in the study. Mild stable forms of diseases such as chronic obstructive pulmonary disease (COPD) are acceptable, and potentially eligible on a case-by case decision between Sponsor and Investigator.
    5. Major depressive disorder within the last 12 months or a Hamilton Rating Scale for Depression (HAM-D) 17 score of more than 12 at screening.
    6. History or presence of cataract (or abnormality identified by slit lamp examination during screening), uveitis, eye trauma or eye irradiation. Minor ophthalmological findings outside lens and cornea discovered during the ophthalmological screening should not lead to exclusion.
    7. Use of any medication that may adversely interact with study measures (antidepressants, typical and atypical antipsychotics, anxiolytics and hypnotics, antiepileptics, others); recent or regular use of an opioid medication.
    8. Use of other MAO inhibitors, pethidine, SSRIs, TCAs, nasal and oral decongestants or cold medicines containing ephedrine, pseudoephedrine, other sympathomimetics (including epinephrine and norepinephrine) and any medication forbidden to be co-administered with MAO inhibitors (e.g. linezolid, albuterol). Occasional use of non-sedative anti-histamines is acceptable.
    9. 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.
    10. Blood donation within the last two months or planned during the study and two months afterwards.
    11. Unwillingness to attend study visits, or be randomised into medication or placebo conditions, or be available for follow up assessments.
    12. Using tobacco products other than cigarettes (e.g., pipes, cigars, snuff, chewing tobacco).
    13. Use of an NRT in the past month (e.g. patch gum, inhaler, nasal spray, or lozenge).
    14. Received an investigational drug for any indication within 30 days prior to study entry.
    15. Had previously participated in a study with an MAO B inhibitor.
    16. Elevation of more than one LFT (> 1.5 fold ULN).
    17. Impaired renal function with an estimated glomerular filtration rate of less than 80 ml/min (calculated according to the Cockcroft-Gault formula) at screening (see
    Section 9.4.2).
    18. ECG parameters at screening after 5 minutes rest in supine position above the stated maximum values or outside the reference range: P: > 130 ms, PQ=PR: 120 - 220 ms, QRS: 40 - 120 ms, QT: > 471 ms (males)/ > 493 ms (females), QTc(B): > 430 ms (males)/ > 450 ms (females), RR: 667 - 1200 ms.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study will be the 4-week CQR for the last four weeks of treatment (Weeks 5 to 8). Analysis of the primary efficacy outcome will be performed using an appropriate non parametric method such as the Chi-Squared test or Fisher’s Exact test. Only the difference between EVT 302 and placebo will be formally tested. For all other treatment comparisons, confidence intervals for the treatment effect will be calculated. A confirmatory analysis on the proportion of responders will be performed using a logistic regression with treatment group as a factor. Potential prognostic factors reported during the screening period will also be examined. Summary statistics by treatment group and visit will be produced for all efficacy and safety parameters, together with changes from baseline if applicable. TEAEs will be classified according to the Medical Dictionary for Regulatory Activities (MedDRA) dictionary and will be tabulated by preferred term and system organ class, by both severity and relationship to study drug.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States No
    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 years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    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) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Information not present in EudraCT
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state400
    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 Decision2008-08-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-03-06
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