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    Summary
    EudraCT Number:2007-002960-85
    Sponsor's Protocol Code Number:NN20372
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-01-11
    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 ConcernedAustria - BASG
    A.2EudraCT number2007-002960-85
    A.3Full title of the trial
    Randomized, double-blind, placebo-controlled add-on trial of the safety and efficacy of RO4917838 in outpatients on olanzapine, quetiapine, risperidone or paliperidone with prominent negative or disorganized thought symptoms
    A.4.1Sponsor's protocol code numberNN20372
    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.3.2Product code RO4917838
    D.3.4Pharmaceutical form Capsule, hard
    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/F03
    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.3.2Product code RO4917838
    D.3.4Pharmaceutical form Capsule, hard
    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/F06
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 - This study will be conducted to investigate whether or not administration of RO4917838 along with their current antipsychotic regimen to stable patients can lead to further improvement in symptoms including the potential for improving cognitive function and negative symptoms in addition to improvement in positive symptoms.
    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.1.2Term 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 evaluate the effect of RO4917838 compared to placebo on negative symptoms based on the mean change from baseline in Positive and Negative Syndrome Scale (PANSS) negative factor score after 8 weeks of treatment
    E.2.2Secondary objectives of the trial
    •Overall symptoms based on the mean change from baseline in total PANSS score •Mean change from baseline for the PANSS subscales and remaining PANSS factors •Negative symptom clinical response based on proportion of patients having a 20% or greater improvement in PANSS negative factor score •Clinical Global scores: CGI-Improvement, CGI-I Improvement in Negative Symptoms, CGI-Severity and CGI-Severity in Negative Symptoms •Cognition status changes based on the Cognitive Battery •Functional response based on the mean change in Personal and Social Performance Scale (PSP) total score •Quality of life based on change in the Schizophrenia Quality of Life Scale (SQLS) •Safety assessments as described in the statistical section •Pharmacokinetics as described in the pharmacokinetics section
    •Biomarker assessments as described in the biomarker section (BSR) •Consistency in safety, efficacy, and PK results of the patients from Japanese sites as compared with patients in the rest of the world
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Capable of providing informed consent and informed consent form signed by the patient before any study assessments are done
    2. Age 18-60
    3. Males or females. If female must meet one or more of the following: a) surgically sterile b) postmenopausal with spontaneous amenorrhea for the past two years with an FSH level greater than 40 mIU/mL c) agree for the 12 weeks of the study to refrain from heterosexual intercourse or d) agree for the 12 weeks of the study 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)
    4. Has a caregiver or some other identified responsible person (eg, family member, social worker, caseworker or nurse) considered reliable by the investigator in providing support to the patient to help ensure compliance with study treatment, study visits and protocol procedures who preferably is also able to provide input helpful for completing study rating scales.
    5. Based on the screening SCID-CT a DSM-IV TR diagnosis of schizophrenia
    6. Outpatient with no hospitalization for worsening of schizophrenia within 3 months (hospitalization for social management within this time is acceptable)
    7. Medically stable over the prior 1 month and psychiatrically stable without symptom exacerbation within prior 3 months
    8. Except for risperidone long-acting, no depot or long-acting antipsychotics or clozapine within 3 months
    9. If on risperidone long-acting, no dose change within 3 months
    10. For oral antipsychotics, no dose change within 1 month
    11. On no more than 2 antipsychotics where risperidone and risperidone long-acting are considered to be two different antipsychotics
    12. Antipsychotic regimen:
    a) Patients must be on a "primary" antipsychotic. Patients may also be on a second antipsychotic. However, if a patient is on a second antipsychotic, by using approximate dose equivalents (explained below), the following will apply:
    i) The amount of the second antipsychotic must be less than the equivalent dose of the primary antipsychotic
    ii) The sum of the primary and secondary antipsychotics must be less than or equal to 6 mg of risperidone equivalents
    b)The six allowed primary antipsychotics* are olanzapine, quetiapine, paliperidone, oral risperidone and risperidone long-acting by injection and aripiprazol. As a primary agent the allowed ranges are:
    i) Risperidone 2-6 mg/day or
    ii) Olanzapine 5-20 mg/day or
    iii) Quetiapine 150-750 mg/day or
    iv) Paliperidone 3-12 mg/day or
    v) Risperidone long-acting injection 25-50 mg every 2 weeks or
    vi) Aripiprazole 6-30 mg/day
    *Information on antipsychotic dosing includedin this protocol provides usual minimum and maximum prescribed doses but should always be used in the dose range according to the approved local prescribing information.
    c) For patients on a second antipsychotic, [Appendix 3] explains, for each primary antipsychotic regimen, what the allowed second antipsychotics are and the maximum dose of the second antipsychotic. The table considers 4 mg risperidone to be equipotent to 15 mg of olanzapine, 600 mg of quetiapine, 9 mg of paliperidone and 37.5 mg of risperidone long-acting (given every 2 weeks) and 15 mg aripiprazole and that this ratio remains the same for all allowed doses (i.e. 2 mg of risperidone is equipotent to 7.5 mg of olanzapine etc.). (The table is based on J Clin Psych 67:8, August 2006 p1197, Table 1).
    13. Total score of 40 or greater on the sum of the 14 negative and disorganized thought/cognition PANSS items in below (items scored 1-7 for a maximum possible score of 98)
    14. Total score of 28 or less on the sum of the 8 positive symptoms PANSS factor items
    a) the score of the items P1, P3, P6 and G9 meet the following requirements:
    i) No more than 2 of the above items have a score of 4
    ii) All of the above items score less than 5
    E.4Principal exclusion criteria
    Treatment history
    1. Previously received RO4917838
    2. Previously entered screening for this study but did not meet inclusion/exclusion criteria based on a screening assessment (see [Table 2])
    3. Participation in a clinical trial within 3 months or more than 2 clinical trials within 12 months
    4. ECT within 6 months
    5. Began a new non-medication treatment for schizophrenia or other psychiatric condition within the last 3 months (e.g. individual psychotherapy, cognitive behavioral therapy, rehabiliative threapy)
    6. Lithium, anticonvulsants, or any other agent used as a mood stabilizer within 4 months
    7. On more than one antidepressant or if on one antidepressant, a change in dose within 3 months
    8. Change in benzodiazepine or sleep medication regimen within 1 month (regimen may be PRN or continuous treatment)
    9. Except for medications mentioned above, receiving any other psychotropic or medication used as a psychotropic within 1 month (defined in Concomitant Medications and Treatment section [9]).
    10. Change in anti-EPS medication within 2 weeks (see Concomitant Medications and Treatment section [9])
    11.Taking any medication which is an inhibitor or inducer of CYP3A4 (see [Appendix 4] for a list of common medications to exclude)
    Diagnosis and psychiatric history
    12. Based on the screening SCID-CT:
    a) other current DSM-IV TR Axis I diagnosis requiring exclusion
    b) alcohol or substance abuse or dependence within 3 months (excluding nicotine)
    13. PANSS item G6, depression moderate or worse
    14. Urine drug screen detects heroin, amphetamines (including MDMA/ecstasy), cocaine, hallucinogens or PCP
    15. In the investigator’s judgment, a significant risk of suicide or violent behavior
    Past and current medical history
    16. History of neuroleptic malignant syndrome
    17. A prior or current general medical condition that may be impairing cognition or other psychiatric functioning (e.g. head trauma, dementia, seizure disorder, stroke, neurodegenerative, inflammatory, infectious, neoplastic, toxic, metabolic, endocrine etc.)
    18. A movement disorder due to antipsychotic treatment not currently controlled with anti-EPS treatment or another movement disorder which may affect the ratings on the EPS scales (e.g. Parkinson's disease)
    19. Pregnant or breastfeeding females
    20. Hemoglobin less than 130 g/L (13 g/dL) in males or 120 g/L (12 g/dL) in females
    21. History of hemoglobinopathy such as thalassemia major or sickle-cell anemia
    22. History of G6PDH (glucose-6-phosphate dehydrogenase) deficiency
    23. History of HIV infection, or history of HepB infection within the past year, or history of HepC infection which has not been adequately treated
    24. QTcF interval greater than 450 msec or other clinically significant abnormality on screening ECG based on centralized reading (Note: retesting for screening ECG is not permitted)
    25. Clinically significant abnormality on screening blood or urine safety tests which does not improve on retesting (for ALT and AST clinically significant is above twice the upper limit of normal)
    26. Gastrointestinal, hepatic or renal disease which may significantly alter the absorption, metabolism or elimination of RO4917838
    27. Significant or unstable physical condition which in the investigator’s judgment may require a change in medication or hospitalization within the next 3 months
    28. Does not make an effortful attempt to complete the cognition battery at screening as explained in section [11.3.3.5].
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is change from baseline at week 8 in PANSS total score.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Biomarker Assessment
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    The end of the study will be considered to be the date of the last visit (including the last follow-up visit) of the last patient in the study
    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 months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 320
    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)
    After treatment period there is a 4 week follow-up period that includes a visits 2 weeks after the end of study treatment and a final visit after a further 2 weeks
    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 Decision2008-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-27
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