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    Summary
    EudraCT Number:2012-002731-28
    Sponsor's Protocol Code Number:P12-01/BP1.4979
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-10-31
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2012-002731-28
    A.3Full title of the trial
    Randomized placebo controlled trial assessing the efficacy and safety of BP1.4979 in smoking cessation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Smoking cessation
    A.4.1Sponsor's protocol code numberP12-01/BP1.4979
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBioprojet
    B.1.3.4CountryFrance
    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 supportBioprojet
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBioprojet
    B.5.2Functional name of contact pointBioprojet clinical department
    B.5.3 Address:
    B.5.3.1Street Address9 rue Rameau
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75002
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0)1 47 03 66 33
    B.5.5Fax number+33(0)1 47 03 66 30
    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.3.2Product code BP1.4979
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 1000036-77-0
    D.3.9.2Current sponsor codeBP1.4979
    D.3.9.3Other descriptive nameNot available
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number15
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Smoking cessation
    E.1.1.1Medical condition in easily understood language
    Smoking cessation
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10008374
    E.1.2Term Cessation of smoking
    E.1.2System Organ Class 100000004869
    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 in heavy smokers willing to quit smoking the efficacy and the
    safety profile of BP1.4979 for smoking cessation on the total abstinence
    measured by subject diary and confirmed by exhaled CO (abstinent ≤ 10
    ppm).
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. males or females, aged 18 to 65 years old
    2. 18 kg/m2 ≤ BMI ≤ 35 kg/m2
    3. a smoking history of at least 10 years
    4. subject smoking at least 15 cigarettes per day at the time being and for at least 30 days before selection.
    5. motivated to quit smoking with a motivation test score > 12 on the Legeron and Lagrue Questionnaire of Motivation (Q-MAT) at the selection and at the inclusion
    6. having already made at least 2 attempts to stop (each of at least 7 days), including at least one attempt with medical and pharmacological
    treatment, at least 30 days before the selection
    7. with no period of abstinence > 3 months in the previous year
    8. Fagerström Test of Nicotine Dependence (FTND)  7 at V0 (screening) and/or at V1 (randomization)
    9. not taking anti-smoking medication
    10. not taking antipsychotic medication, antidepressant except Selective Serotonin Reuptake Inhibitors (SSRIs) prescribed for at least one month (e.g. fluoxetine, paroxetine, fluvoxamine, sertraline, citalopram, escitalopram, venlafaxine, milnacipran, duloxetine) and/or any other psychotropic medication except benzodiazepine treatment stable for at least one month prior to inclusion in the study.
    11. females of child-bearing potential must use a medically accepted effective method of birth control, agree to continue this method for the duration of the study and be negative to serum pregnancy test performed at the screening visit. Females should not be breast-feeding subject.
    12. in the opinion of the investigator, the subject must have adequate
    support to comply with the entire study requirements as described in the protocol (e.g. transportation to and from trial site, self rating scales,
    drug compliance, scheduled visits, etc).
    13. subject must have voluntarily expressed willingness to participate in this study, understand protocol procedures and have signed and dated an informed consent prior to beginning any protocol required
    procedures.
    14. attend usual smoking cessation counseling provided by investigator.
    E.4Principal exclusion criteria
    1. any significant psychiatric illness (schizophrenia, bipolar disorder, severe depression, dementia...) or mood disorder, assessed by the Beck
    Depression Inventory (BDI) (exclusion if  8 and/ or item G ≠ 0).
    2. Hospital Anxiety and Depression (HAD) scale (A + D ≥ 19, the day of the selection and inclusion).
    3. substance use disorder (except nicotine).
    4. Alcohol Use Disorders Identification Test (AUDIT)  8.
    5. any use of non prescription opiates / stimulants (amphetamines),
    cocaine or cannabis in the 3 previous months.
    6. positive urinary test on opiates, amphetamine, cannabis or cocaine.
    7. other active clinically significant illness, including unstable
    cardiovascular, or neoplasic pathology which could interfere with the study conduct or counter-indicate the study treatments or place the
    subject at risk during the trial or compromise the study participation.
    8. subject with a known history of long QTc syndrome (e.g. syncope or
    arrhythmia) or presenting any significant serious abnormality of the ECG (e.g. recent myocardial infarction), or QTcB interval strictly higher than 450 ms for man and 460 ms for woman (electrocardiogram Bazett's corrected QT interval: QTc=QT/ [60/HR]).
    9. subject with severe hepatic impairment or with severe renal
    impairment, or with any other significant abnormality in the physical examination or clinical laboratory results (e.g positive laboratory test for Hepatitis B surface antigen (HBsAg), or anti-HIV 1/2 or anti- HCV antibodies).
    10. known hypersensitivity to the tested treatment including active
    substance and excipients.
    11. subject smoking cigars or pipes in addition to cigarettes (patient
    should have stopped cigars or pipes at least 30 days before V0)
    12. subject taking any antismoking medication (e.g. bupropion,
    varenicline, clonidine, cytisine..), and/ or Nicotine Replacement Therapy (NRT) in the previous month.
    13. subject taking antipsychotic medication, or antidepressants other
    than SSRIs (SSRIs taking for at least one month).
    14. subject taking anxiolytics (except benzodiazepines at stable dose for
    at least 1 month).
    15. subject taking any prescription drug containing amphetamines.
    16. subject on anti smoking targeted Cognitive Behavioral Therapy (CBT)
    or any antismoking oriented psychotherapy or acupuncture or using an electronic cigarette.
    17. subject participating in another study and the use of any
    investigational therapy within the 30 days prior to the entry in this study.
    18. subject without any medical care insurance.
    19. pregnant woman or a pregnancy detected with a positive serum pregnancy test performed at the screening visit.
    20. male subject who wants to conceive a child for the whole duration of the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary measure of efficacy will be 4-week prolonged abstinence
    from smoking cigarettes at the end of 12-week double-blind treatment
    phase (i.e. from V3 to V4).
    The continuous abstinence measured by subject diary and verified by
    exhaled CO (abstinent ≤ 10 ppm) will define response to the treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During treatment phase and up to 3 months after treatment.
    E.5.2Secondary end point(s)
    • 7-day tobacco Point Prevalence Abstinence (PPA) will be assessed at
    each visit by analysis of cigarettes consumption using self-report diaries and measurement of exhaled CO
    • daily cigarettes consumption (Measure: mean consumption variation to baseline to determine % of subjects having reduced cigarettes
    consumption between baseline and last week of treatment.)
    • assessment of craving and urge to smoke performed at each visit except screening (V0) by QSU-Brief Questionnaire (Measure: variation
    from V1 to V2, V3, V4, V5 and to V-TQD), on (7-days PPA) responders
    • continuous abstinence from V3 (W8) to V6 (W16) and from V3 (W8) to V8 (W24)
    • nicotine withdrawal syndrome assessed by Minnesota Nicotine
    Withdrawal Scale (MNWS) (assessing urge to smoke, depressed mood,
    irritability, anxiety, poor concentration, restlessness, increased appetite and insomnia). (Measure: variation from V1 to V2, V3, V4, V5 and to VTQD), on (7-days PPA) responders
    • smoking satisfaction measured by the modified Cigarette Evaluation
    Questionnaire (mCEQ) (recording measures of smoking satisfaction,
    psychological reward, enjoyment of respiratory tract sensations, craving
    reduction and aversion) if the subject continue to smoke. (Measure:
    variation from V1 to V2, V3, V4, V5 and to V-TQD), in patients still
    smoking.
    • body weight variation in treatment responders
    • BDI mean depressive score variation in responders
    • abstinence in a sub-group of subjects having TQD up until treatment Day8
    • safety will be assessed by evaluation of adverse events, various
    questionnaires and vital signs (measurement of heart rate, blood
    pressure, and body weight) at each study visit, by physical examinations
    (V0 and V4), ECG and laboratory tests (blood chemistry, haematology,
    urinanalysis tests, prolactin dosage) at screening (V0), after 4-week
    treatment (V2) and at V4.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the whole study duration.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    1 additional PL1 week single-blind for each patient at the 12th week.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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 No
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 250
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 250
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Neither specific treatment or care after the patient participation in the trial are anticipated. It is assumed that the subject will be treated according to the usual physician clinical practice.
    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 Decision2013-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-10-09
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