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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-001097-90
    Sponsor's Protocol Code Number:11915A
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-03-04
    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 ConcernedGreece - EOF
    A.2EudraCT number2007-001097-90
    A.3Full title of the trial
    A one-year multinational, multi-centre, randomised, double-blind, parallel-group, fixed-dose, bifeprunox study combining a 12 week placebo-controlled, quetiapine-referenced phase with a 12-month quetiapine-controlled phase in patients with schizophrenia.
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code number11915A
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorH. Lundbeck A/S
    B.1.3.4CountryDenmark
    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 nameBifeprunox
    D.3.2Product code Lu02-754/DU127090
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNBifeprunox
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25;0,5;5;10; 20 to 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 Information not present in EudraCT
    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 nameQuetiapine
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNQuetiapine
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25; 100; 300 to 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 placeboCapsule, hard
    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
    Schizophrenia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 10.0
    E.1.2Level LLT
    E.1.2Classification code 10039626
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to show superior efficacy of fixed doses of bifeprunox (20 mg/day) versus placebo following 12 weeks of treatment in subjects with schizophrenia inadequately controlled in the maintenance phase.
    E.2.2Secondary objectives of the trial
    Key secondary objective:
    To show non-inferior efficacy of fixed doses of bifeprunox (20 mg/day) versus fixed doses of quetiapine (600 mg/day) following 12 months of treatment in subjects with schizophrenia inadequately controlled in the maintenance phase.
    Other secondary objectives:
    To compare the safety and tolerability of 12 weeks treatment with fixed doses of bifeprunox (20 mg/day) to that of placebo and quetiapine (600 mg/day)
    To compare the safety and tolerability of 12 months treatment with fixed doses of bifeprunox (20 mg/day) to that of quetiapine (600 mg/day)
    To determine and compare the effect on functional outcomes, quality of life and treatment compliance of 12 weeks treatment with fixed doses of bifeprunox (20 mg/day) to that of placebo and quetiapine (600 mg/day)
    To determine and compare the effect on functional outcomes, quality of life and treatment compliance of 12 months treatment with fixed doses of bifeprunox (20 mg/day) to that of quetiapine (600 mg/day)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The subject has a primary diagnosis of schizophrenia according to current Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR: codes 295.10, 295.20, 295.30, 295.60, 295.90).
    .The subject has a CGI-S score of ³ 4 (moderately ill) at screening and baseline.
    ·The subject has a PANSS total score ³ 60 at screening and baseline.
    ·The subject is either an inpatient, partially hospitalised, or outpatient for whom the centre can document at least monthly contacts (personal or by telephone) during a minimum of 3 months prior to screening.
    ·The subject’s antipsychotic treatment has been kept as follows:
    -At screening: the antipsychotic medication(s) has/have remained the same within 8 weeks prior to screening
    -At baseline: the antipsychotic medication(s) has/have not been changed (agent(s) and dose(s) between screening and baseline.
    ·The subject is in a maintenance phase and has not had an acute exacerbation according to the investigator’s judgement.
    -At screening: within 8 weeks prior to screening
    -At baseline: between screening and baseline (4 weeks).
    -The subject has a primary diagnosis of schizophrenia according to current Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR: codes 295.10, 295.20, 295.30, 295.60, 295.90).
    E.4Principal exclusion criteria
    1. The sb has a current Axis I primary psychiatric diagnosis other than schizophrenia (DSM-IV-TR criteria).
    2. The sb is at significant risk of suicide defined as
    - in the 12 months prior to screening, at significant risk of suicide according to the investigator judgment, and/or
    - a life threatening suicide attempt within 3 years prior to screening.
    3. The sb has shown violent behaviour within 12 months prior to screening, according to the investigator’s judgment.
    4. The sb is treatment resistant to antipsychotic treatment, according to investigator’s judgment.
    5. The sb has been treated with clozapine within 60 days prior to screening.
    6. The sb has other psychiatric, neurological or behavioural disorders that may interfere with the conduct or interpretation of the results of the study.
    7. The sb has a history of moderate or severe head trauma or other neurological disorders and systemic medical diseases, which are likely to affect the central nervous system functioning.
    8. The sb has known ischemic heart disease or a history of myocardial infarction (within the previous 12 months), coronary artery bypass surgery or percutaneous transluminal coronary angioplasty.
    9. The sb has a history of neuroleptic malignant syndrome.
    10. The sb has an uncorrected hypothyroidism or hyperthyroidism.
    11. The sb has/has had a current diagnosis or history of substance (except nicotine, caffeine) or alcohol abuse based on DSM-IV-TR criteria within 6 months prior to screening.
    12. The sb has a positive urine drug screen at screening with the exception that positive results for opioids, cannabinoids and benzodiazepines will be evaluated by the investigator and Lundbeck medical expert on the potential impact for study participation.
    13. The sb has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to or has other contraindications to serotonergic agents, dopamine antagonists or dopamine agonists.
    14. The sb has within 2 months prior to screening received antidepressants or mood-stabiliser (specified in Appendix II).
    15. The sb uses disallowed medication (specified in Appendix II), or it is anticipated that the sb will require treatment with at least one of the disallowed concomitant medications during the study.
    16. The sb has a clinically significant unstable illness, for example, hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, haematological, autoimmune or metabolic disturbance other than those originating from the antipsychotic treatment. Adequately treated hypertension and diabetes are not considered an exclusion criterion.
    17. The sb has a malignant disease or a history of malignant disease, other than adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin, within the past 5 years prior to screening.
    18. The sb has clinically significant abnormal vital signs.
    19. The sb has uncontrolled or symptomatic hypotension, or orthostatic hypotension which is defined as a decrease of 30 mmHg or more in systolic blood pressure and/or a decrease of 20 mmHg or more in diastolic blood pressure after approximately 1 minute in upright position, compared to the previous supine blood pressure or development of symptoms. The abnormal value should be confirmed at two separate measurements.
    20. The sb has a history of repeated vasovagal syncope.
    21. The sb has one or more laboratory values outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant.
    22. The sb has a clinically significant abnormal ECG at screening and baseline according to the investigator´s judgement.
    23. The sb has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
    24. The sb is currently being treated with depot antipsychotic medication.
    25. The sb has received electro-convulsive therapy (ECT) within 12 weeks prior to screening.
    26. The sb has been treated with any investigational medicinal product within 8 weeks prior to screening.
    27. The sb has been previously exposed to bifeprunox (Lu 02-754/DU 127090).
    28. The sb has been treated with quetiapine and failed to respond to or tolerate the drug.
    29. The sb has been treated with quetiapine within 1 year prior to screening.
    30. The sb is pregnant or breast-feeding.
    31. The sb, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason. This includes the fact that the sb is unable to give informed consent, showed by a score of ³ 5 (moderate-to-severe) at any of the following PANSS items at screening and baseline:
    - P2 (conceptual disorganisation)
    - P7 (hostility)
    - G8 (uncooperativeness)
    32. The sb is a member of the site personnel or their immediate families.
    E.5 End points
    E.5.1Primary end point(s)
    · Change in PANSS total score from baseline to Week 12, using last observation carried forward (LOCF)
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 No
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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 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 state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 450
    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)
    described in the protocol
    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 Decision2008-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-06-19
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