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    Summary
    EudraCT Number:2010-020718-26
    Sponsor's Protocol Code Number:WN25305
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-12-24
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-020718-26
    A.3Full title of the trial
    Phase III, multi-center, randomized, 12-week, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of RO4917838 in patients with sub-optimally controlled symptoms of schizophrenia treated with antipsychotics followed by a 40-week double-blind, parallelgroup, placebo-controlled treatment period.
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberWN25305
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 nameGlyT1 (1) inhibitor
    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.3.9.1CAS number 845614-11-1
    D.3.9.2Current sponsor codeRO4917838/F18
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 nameGlyT1 (1) inhibitor
    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.3.9.1CAS number 845614-11-1
    D.3.9.2Current sponsor codeRO4917838/F20
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Adjunctive treatment of patients with sub-optimally controlled symptoms of schizophrenia. Sub-optimally controlled patients are defined as those who on their current medication have persistent symptoms of psychosis.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039626
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Evaluate the efficacy after 12 weeks of treatment with RO4917838 vs. placebo, as adjunct to antipsychotics, in the PANSS positive symptom factor score in patients with suboptimally controlled symptoms of schizophrenia; • Evaluate the safety and tolerability after 12 weeks of treatment with RO4917838 vs. placebo as adjunct to antipsychotics, in patients with sub-optimally controlled symptoms of schizophrenia.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to evaluate effects of 12 weeks of treatment with RO4917838 vs. placebo in patients with suboptimally controlled symptoms of schizophrenia treated with antipsychotics with respect to: • Symptoms domains of schizophrenia: PANSS total score, PANSS factor score of negative symptoms, disorganized thought, hostility/excitement, anxiety/depression; and PANSS syndrome subscale scores of positive, negative and general psychopathology symptoms at week 12; • The Clinical Global Impression - Improvement (CGI-I) positive and overall symptoms with “much” or “very much” improvement at week 12; • Clinical Global Impression of severity and improvement on overall and positive symptoms at week 12; • Personal and Social Performance (PSP) total score at 12 week; • Safety and tolerability of 52 weeks of randomized study treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Demographic 1. Male and female patients, ages 18 and above, inclusive; 2. Female patients who are not either surgically sterile (tubal ligation or removal of ovaries or uterus) or post-menopausal (no spontaneous menstrual periods for at least one year confirmed by a negative hormone panel) must agree for the entire study duration to use one of the following forms of contraception: (1) systemic hormonal treatment (2) an IUD which was implanted at least 2 months prior to screening or (3) ``double-barrier`` contraception (condom, diaphragm and spermicide are each considered a barrier), or agree to remain sexually abstinent during the entire study period or (4) agree to remain sexually abstinent during the entire study period (when contraception is not acceptable for cultural or religious beliefs). Procedural 3. Sign written informed consent after the scope and nature of the investigation have been explained to them before screening evaluations and willing to comply with the study restrictions. 4. Are fluent in the language of the investigator, study staff (including raters), and the informed consent. 5. Have a caregiver or an identified responsible person (e.g., family member, social worker, case-worker, or nurse that spends > 4 hours/week with the patient) considered reliable by the investigator in providing support to the patient to ensure compliance with study treatment, assessment visits, and protocol procedures and who will be able to provide input helpful for caregiver needs to be able and willing to attend study/clinic visits with the patients or to provide input via the phone. Neuropsychiatric 6. Based on the screening Structured Clinical Interview for DSMIV – Clinical Trial (SCID-CT), a DSM-IV-TR diagnosis of schizophrenia, paranoid (295.30), disorganized (295.10), residual (295.60), undifferentiated (295.90) or catatonic subtype (295.20). 7. A score of 4 (moderate) or more on at least two of any of the following, PANSS items (P1 - Delusions, P3 - Hallucinatory behavior, P6 - Suspiciousness, and G9 - Unusual thought content). 8. A score of ≥ 70 in the PANSS total score, Appendix 4. 9. Are at least moderately ill as defined by severity of CGI-S of positive symptoms score ≥4. Et al...
    E.4Principal exclusion criteria
    Medical Status 1. The patient has evidence of clinically significant, uncontrolled or unstable cardiovascular, renal, hepatic (incl. AST or ALT at or above 3x ULN, or bilirubin at or above 2x ULN), gastrointestinal, hematologic, immunological, neurological, endocrine, metabolic or pulmonary disease, anorexia [body mass index (BMI) < 18.5] or obesity [BMI > 40] (as determined by medical history, clinical laboratory or ECG results, or physical examination) or any other medical disorder that would increase the risk associated with taking study medication or would confound the interpretation of study results. 2. Hemoglobin less than 130 g/L (13 g/dL) in males or less than 120 g/L (12 g/dL) in females. 3. The patient has history of hemolytic anemia including hemoglobinopathies (e.g. thalassemia major, sickle-cell anemia), RBC membrane diseases (e.g. hereditary sphreocytosis), or G6PDH (glucose-6-phosphate dehydrogenase) deficiency or anemia of any cause. 4. Any clinically significant abnormal laboratory data, vital signs, physical examination at screening or baseline which in the opinion of the investigator, would interfere with safety assessments. 5. Clinically significant electrocardiogram (ECG) abnormality at screening, including sinus bradycardia (resting heart rate < 50 beats per minute), atrial fibrillation, 2nd or 3rd degree AV block (AVB), prolonged QTc (QTcF ≥ 450 ms in males or ≥ 470 ms in females) history of congenital long QT syndromes, or risk of Torsades de Pointes because of family history of sudden death, etc. 6. Positive result on the serum pregnancy test or are breast feeding at screening, or intend to become pregnant during the course of the trial. 7. History of neuroleptic malignant syndrome (NMS). Neuropsychiatric 8. Has treatment resistant schizophrenia as judged by the treating physician OR have failed two trials, meeting all of the following criteria:• 6 weeks duration of each trial; • two different classes of antipsychotics; • antipsychotic doses were ≥ 600 mg/day chlorpromazine or ≥ 6 mg/day risperidone equivalents; • no clinically significant response and absence of good social and occupational functioning in past 5 years. 9. Have met criteria for remission defined as: PANSS scores of <= 3 (mild or less) on all of the following items: P1 - Delusions, P2 - Conceptual disorganization, P3 - Hallucinatory behavior, G5 - Mannerisms/posturing, G9 - Unusual thought content, N1 - Blunted affect, N4 - Social withdrawal, N6 - Lack of spontaneity at screening. 10. Based on the DSM-IV-TR criteria and screening SCID-CT has: • other current DSM-IV-TR Axis I diagnosis, such as but not limited to major depression, bipolar, obsessive compulsive or schizoaffective disorders; • alcohol or substance dependence within 12 months or abuse within 3 months with the exception of nicotine; • dementia, delirium and other amnestic disorder per DSM-IVTR. 11. Diagnosis of mental retardation or severe organic brain syndromes. Et al...
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy: Mean change from baseline in the PANSS positive symptom factor score after 12 weeks of treatment with RO4917838 vs. placebo.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tollerabilita`, qualita` della vita, biomarcatori
    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) 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 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
    Ultima visita dell`ultimo paziente quattro settimane dopo l`ultima dose prevista dal protocollo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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.1.3Elderly (>=65 years) Yes
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 222
    F.4.2.2In the whole clinical trial 600
    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)
    A tutti i pazienti che completeranno i periodi di trattamento 1 e 2 (56 settimane) sara` offerta la possibilita` di ricevere il farmaco attivo in una fase di estensione a lungo termine
    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 Decision2010-12-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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