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    Summary
    EudraCT Number:2006-003080-31
    Sponsor's Protocol Code Number:172003
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-10-24
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2006-003080-31
    A.3Full title of the trial
    A multi-center, double-blind, flexible-dose efficacy trial with Org 25935 versus placebo as add-on therapy in subjects with predominant, persistent negative symptoms of schizophrenia treated with a stable dose of a second generation antipsychotic.
    A.3.2Name or abbreviated title of the trial where available
    Glycine uptake Inhibitor Add-on in Negative symptoms Trial (GIANT).
    A.4.1Sponsor's protocol code number172003
    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 SponsorNV Organon
    B.1.3.4CountryNetherlands
    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 nameOrg 25935
    D.3.2Product code Org 25935
    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.3.9.2Current sponsor codeOrg 25935
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 Yes
    D.3.11.13.1Other medicinal product typea medicinal product with an active substance of chemical origin
    D.IMP: 2
    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 nameOrg 25935
    D.3.2Product code Org 25935
    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.3.9.2Current sponsor codeOrg 25935
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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 Yes
    D.3.11.13.1Other medicinal product typea medicinal product with an active substance of chemical origin
    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
    Schizophrenia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate clinical and statistical superiority of Org 25935 over placebo on the amelioration of negative symptoms in subjects with schizophrenia who are concurrently treated with a stable dose of a second generation antipsychotic (SGA).
    E.2.2Secondary objectives of the trial
    • To establish the safety and tolerability of oral doses up to and including 32 mg Org 25935 per day
    in subjects with schizophrenia who are concurrently treated with a stable dose of a SGA;
    • To evaluate the effects of Org 25935 on overall disease severity;
    • To evaluate the effects of Org 25935 on positive symptoms;
    • To evaluate the effects of Org 25935 on depressive symptoms;
    • To evaluate the effects of Org 25935 on cognitive functions;
    • To evaluate the effects of Org 25935 on neurological soft signs;

    • To evaluate the effects of Org 25935 on extrapyramidal symptoms;
    • To evaluate the effects of Org 25935 on level of functioning;
    • To collect population pharmacokinetic data;
    • To evaluate whether particular patient characteristics influence treatment efficacy or safety.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. provide written informed consent after the scope and nature of the investigation, including
    recording of interviews for second opinion, have been explained to them before screening;
    2. be between 18 and 55 years of age inclusive at screening;
    3. be (if female) surgically sterile, post menopausal ≥1 year at screening, or when of childbearing
    potential, using one of the following contraceptive methods:
    - an intra uterine device (IUD);
    - hormonal contraceptives in combination with a barrier method;
    - a condom, used in combination with a spermicidal paste or prepared with such a paste;
    4. be able to speak, read, understand, and possess the ability to respond to questions
    and follow simple instructions in a language in which the investigator is fluent and into which
    any required documents and instructions, including the informed consent, have been translated;
    5. be diagnosed at the screening interview with non-first-episode schizophrenia meeting DSM-IV criteria;
    6. be treated with an oral or intramuscular stable dose of one of the following second generation
    antipsychotics (SGAs): aripiprazole, olanzapine, quetiapine, risperidone, or ziprasidone;
    7. be in the non-acute phase of their illness and clinically stable for the past 3 months at
    the time of screening, as demonstrated by:
    - treatment with the current SGA for at least 12 weeks prior to screening;
    - no dose change of the SGA or change in medication to treat clinical symptoms of schizophrenia
    in the past 4 weeks prior to screening;
    - no increase in level of psychiatric care due to worsening of symptoms of schizophrenia
    in the past 12 weeks prior to screening;
    - no jailing or imprisonment in the past 12 weeks prior to screening;
    8. present a score ≥ 4 on three or more of the following PANSS items (Marder factors for
    negative symptoms) at screening: blunted affect (N1), emotional withdrawal (N2), poor rapport (N3), passive
    social withdrawal (N4), lack of spontaneity (N6), motor retardation (G7), active social avoidance (G16);
    9. present an overall PANSS negative subscale (Marder factors) score > 20;
    10. be medically stable and receiving standard therapies at a stable dose in the past 4 weeks prior
    to screening for treatment of their medical condition if they have hypothyroidism, diabetes,
    high blood pressure or chronic respiratory conditions;
    11. have a caregiver or an identified responsible person (e.g. family member, social worker or
    nurse) considered reliable by the investigator in providing support to the subject to ensure
    compliance with study treatment and protocol procedures.
    E.4Principal exclusion criteria
    12. a primary psychiatric diagnosis other than schizophrenia per the allowed DSMIV criteria in
    the 30 days prior to screening;
    13. a PANSS positive subscale score ≥ 20 at screening;
    14. more than ‘moderate’ severity (a score ≥ 5) on two or more of the following PANSS positive
    symptom items at screening: delusions [P1], hallucinatory behavior [P3], excitement [P4],
    grandiosity [P5], suspiciousness/persecution [P6]
    15. a score ≥ 9 on the modified InterSePT Scale for Suicidal Thinking (ISST) at screening;
    16. a score ≥ 9 on the Calgary Depression Scale for Schizophrenia (CDSS) at screening;
    17. a score ≥ 3 on the clinical global impression of Parkinsonism of the abbreviated Extrapyramidal
    Symptom Rating Scale (ESRS-A) at screening;
    18. untreated or uncompensated clinically significant renal, endocrine, hepatic, respiratory,
    cardiovascular, hematological, immunological or cerebrovascular disease, malignancy,
    or other chronic and/or degenerative process at screening;
    19. a (history of) seizure disorder beyond childhood or when the subject is taking any
    anticonvulsants to prevent seizures;
    20. a concurrent diagnosis of mental retardation or organic brain syndrome;
    21. a clinically relevant visual disturbance, such as cataract, color blindness, macular degeneration,
    glaucoma, or retinal disease;
    22. any clinically meaningful abnormal laboratory, vital sign, physical examination or ECG finding which,
    in the opinion of the investigator, may interfere with the interpretation of safety or efficacy evaluations;
    23. a concurrent diagnosis of substance dependence other than nicotine or caffeine dependence
    in the past 6 months prior to screening;
    24. a positive result on the urine alcohol/drug screen for alcohol or illicit drugs;
    25. breast-feeding woman, or a positive result of urine pregnancy test (at screening),
    or plan to become pregnant during the course of the trial (females only);
    26. treatment with high doses of benzodiazepines (> 4 mg per day lorazepam or equivalent);
    27. an imminent risk of self-harm or harm to others;
    28. treatment with clozapine in the past 6 months prior to screening;
    29. treatment with lithium, valproate, lamotrigine, pregabalin, gabapentin, or carbamazepine
    in the past 12 weeks prior to screening;
    30. exposure to an investigational drug within 6 months prior to screening;
    31. non-compliance in the management of the disease in the past 12 weeks prior to screening;
    32. treatment start, or dose change of an anticholinergic drug in the past 4 weeks prior to screening;
    33. treatment start, or dose change of an (additional) antipsychotic, antidepressant, hypnotic or
    anxiolytic in the past 4 weeks prior to screening.
    34. a blood potassium level < 3.5 mmol/L or a QTc interval (Fridericia corrected) > 450 ms at screening;
    35. no demonstrated benefit of antipsychotic treatment within the previous five years.
    E.5 End points
    E.5.1Primary end point(s)
    The total score of the first 22 Items on SANS (Scale for the Assessment of Negative Symptoms).
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 No
    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.8.3 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-10-24. Yes
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 136
    F.4.2.2In the whole clinical trial 180
    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)
    No treatment with the investigational product beyond the final scheduled visit will be allowed under the current 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 Decision2006-12-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-10-24
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