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    Summary
    EudraCT Number:2010-019897-33
    Sponsor's Protocol Code Number:2522518514
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-08-09
    Trial 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2010-019897-33
    A.3Full title of the trial
    Selective D1 activation by addition of L-Dopa to antipsychotic treatment in patients with schizophrenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Brain activation by addition of L-Dopa to normal antipsychotic treatment in patients with schizophrenia
    A.3.2Name or abbreviated title of the trial where available
    ALOHA
    A.4.1Sponsor's protocol code number2522518514
    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 Sponsorerasmus mc
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportErasmus MC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC
    B.5.2Functional name of contact pointS. Kushner
    B.5.3 Address:
    B.5.3.1Street Address's Gravendijkwal 230
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 CE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31107031510
    B.5.5Fax number31107044666
    B.5.6E-mails.kushner@erasmusmc.nl
    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 Yes
    D.2.1.1.1Trade name Sinemet
    D.2.1.1.2Name of the Marketing Authorisation holdermerck sharp & dohme bv haarlem
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameSinemet
    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 INNLEVODOPA
    D.3.9.1CAS number 59-92-7
    D.3.9.3Other descriptive nameL-dopa
    D.3.9.4EV Substance CodeSUB08468MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number800
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCARBIDOPA
    D.3.9.1CAS number 38821-49-7
    D.3.9.4EV Substance CodeSUB06126MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number200
    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
    patients with psychotic symptoms, diagnosed with schizophrenia
    E.1.1.1Medical condition in easily understood language
    Schizophrenia with predominantly
    - negative symtoms: loss of interest, social withdrawl, affect flattening
    - decline in cognitive functions (i.e. working memory)
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To study whether cognitive functions in patients with schizophrenia are affected by addition of L-dopa to optimized conventional (D2-blocking) antipsychotic treatment 2. To study whether negative psychotic symptoms are affected by addition of L-dopa to optimized conventional (D2-blocking) antipsychotic treatment
    E.2.2Secondary objectives of the trial
    3. To study whether positive psychotic symptoms will be affected by L-dopa addition to optimized conventional (D2-blocking) antipsychotic treatment? 4. To study whether extrapyramidal symptoms, as frequently seen in patients with schizophrenia who are treated with conventional (D2-blocking) antipsychotic treatment, are reduced by addition of L-dopa.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All patients will be recruited from the Psychiatry ward of the Erasmus Medical Center, Rotterdam, and diagnosed according to DSM-IV criteria by a senior psychiatrist Patients will be included if they meet the criteria for schizophrenia. Further inclusion criteria inpatients aged 18-40 years with a diagnosis of schizophrenia, stable under haloperidol or risperidone treatment (≤20 points, or >3 points on no more than three items on PANSS positive symptom scale), with significant negative symptoms (total of >20 points, or >3 points on two items on PANSS negative symptom scale) are eligible for the study.
    E.4Principal exclusion criteria
    pregnancy,use of psychotropic medication other than benzodiazepines serious neurological disorders. Subjects will also be excluded when they cannot understand Dutch language sufficiently to understand the purposes and implications of the experiment.
    E.5 End points
    E.5.1Primary end point(s)
    There will be three primary outcome measures. The first primary outcome measure is the change in verbal memory, as compared between patients receiving placebo vs those receiving L-Dopa. Verbal memory is assessed by the Hopkins Verbal Learning Test-Revised (HVLT-R), which is included in the MATRICS. Earlier studies have reported a great difference in verbal memory function between patients with schizophrenia and healthy controls (e.g. Cascella et al., 2008). We expect L-dopa addition will lead to an improvement of verbal memory function of at least 25% towards the level of healthy control subjects. Based on the effect size found in earlier studies comparing patients with schizophrenia with healthy controls (Cascella et al., 2008), a power analysis indicates we would need to include approximately 40 patients in order to reliably show a 25% increase in verbal memory function. The second primary outcome measure is the alteration in working memory as assessed by the N-Back, task as compared between patients receiving placebo vs those receiving L-Dopa. Earlier studies have shown a significant difference in accuracy and reaction time in a 2-back task, between patients with schizophrenia and healthy controls (Schneider et al., 2007; Karch et al, 2009). By adding L-dopa to antipsychotic treatment, we aim to improve the working memory of patients with schizophrenia with about 50%. Based on the effect sizes found in previous studies (Schneider et al., 2007; Karch et al., 2009), a power analysis shows that in order to show a 50% improvement in working memory, we would need to include approximately 40 patients. The third primary outcome measure is the improvement in negative symptoms as assessed by the PANSS negative symptoms subscale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 0, 1, 2, 3, and 6 weeks
    E.5.2Secondary end point(s)
    Secondary outcome measures are change in positive symptoms as assessed by the PANSS positive symptoms score, the improvement in cognitive functions other than verbal memory and working memory, as assessed by the MATRICS, potential changes in frontal functions as assessed by the FAB, decrease of extrapyramidal symptoms as assessed by the ESRS, improvement in general functioning as assessed by the HoNOS, and CGI, and improvement of subjective wellbeing as assessed by the SWN.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PANSS, MATRICS, and ESRS: at 0,1,2,3, and 6 weeks
    HoNOS: at 0, 1, and 6 weeks
    FAB, CGI, and SWN: at 0 and 6 weeks
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    rct on the efficacy of L-dopa addition to haloperidol or risperidone
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    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 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
    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 years0
    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 years0
    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: 50
    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 2010-08-09. 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 state50
    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)
    Regular care and treatment. Patients will be given the opportunity to continue l-dopa addition on a non-research basis if they wish to do so.
    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 Decision2010-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-14
    P. End of Trial
    P.End of Trial StatusOngoing
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