Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2013-002713-35
    Sponsor's Protocol Code Number:AXCT01-01-03-2013
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-04-25
    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 ConcernedGreece - EOF
    A.2EudraCT number2013-002713-35
    A.3Full title of the trial
    Randomized, controlled trial of the effectiveness of add-on tolcapone to usual antipsychotic therapy on cognitive and negative symptoms of patients with schizophrenia genotyped for COMT polymorphisms
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness of tolcapone in schizophrenia
    A.4.1Sponsor's protocol code numberAXCT01-01-03-2013
    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 SponsorMediPsych SA
    B.1.3.4CountryGreece
    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 supportGeneral Secretary for Research and Technology-Dept. of Education
    B.4.2CountryGreece
    B.4.1Name of organisation providing supportMediPsych SA
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMediPsych SA
    B.5.2Functional name of contact pointEvangelia Tsapakis
    B.5.3 Address:
    B.5.3.1Street Address82, M. Alexandrou Street
    B.5.3.2Town/ cityHeraklion
    B.5.3.3Post code71305
    B.5.3.4CountryGreece
    B.5.6E-mailemtsapakis@doctors.org.uk
    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 Tasmar
    D.2.1.1.2Name of the Marketing Authorisation holderMEDA AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nametolcapone
    D.3.4Pharmaceutical form Coated 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 INNTOLCAPONE
    D.3.9.1CAS number 134308-13-7
    D.3.9.4EV Substance CodeSUB11151MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboCoated 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
    schizophrenia
    E.1.1.1Medical condition in easily understood language
    schizophrenia
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level HLGT
    E.1.2Classification code 10039628
    E.1.2Term Schizophrenia and other psychotic disorders
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Main Objective:
    The main objective of this study is to investigate whether the drug tolcapone - a dopaminergic agent and an inhibitor of the enzyme COMT, now used as adjunctive therapy in Parkinson disease, improves overall the negative and cognitive symptoms of schizophrenia more than antipsychotic treatment alone.
    As the beneficial effect of tolcapone on prefrontal function depends on the presence of allele Val, the study aims to show that more than 70-80 % of schizophrenia patients may benefit on the prefrontal functioning and consequently exhibit an improvement of negative and cognitive symptoms.
    E.2.2Secondary objectives of the trial
    Secondary objective:
    To examine the relationship between the possible beneficial effect of tolcapone and the COMT genotype of patients. More specifically, to show that tolcapone exhibits a substantial beneficial effect on the negative and cognitive symptoms of schizophrenia in homozygous Val / Val patients ( 30% of the population) , is quite beneficial to heterozygous Val / Met patients ( 50 % of the population) and shows no effectiveness in homozygous Met / Met patients (20 % of the population) . The proposed treatment offers advantages also from a pharmaco - economic point of view , as it could be made to be determined the patient will respond very well, the patient will respond well and the patient will not respond at all.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A patient must meet all the following criteria to be eligible for this study:
    1. The patients will be male or female, aged from 18 to 65 years old.
    2. The patient is willing and able to provide signed informed consent form. For patients in acute relapse, legal representatives will be required to sign the consent form.
    3. The patient will have an official diagnosis of Schizophrenia or Schizoaffective disorder according to the DSM-IV TR criteria and will display the cognitive and negative symptoms of schizophrenia.
    4. The patient will be either at relapse of the disorder (Group 1) or at the early stages of the disease and/or stabilised (Group 2) and takes standard antipsychotic medication.
    5. If the patient is sexually active, then s/he must satisfy one of the following criteria:
    a) For Women: They should not be pregnant or be in lactation period. They should be either surgically sterilized or be in postmenopausal period. The patient’ partner should apply an accepted and highly effective contraceptive regimen (a shape which leads to failure rate < 1%) for 4 weeks before the preliminary assessment.
    b) For Men: They should be either surgically sterilized or patient or patient’partner should use an accepted and highly effective method of contraception during administration and for 4 weeks after the last dose of research product.
    E.4Principal exclusion criteria
    A patient who meets any of the following criteria will be excluded from this study.
    1. The patient is hypersensitive to tolcapone.
    2. The patient has hereditary problems of galactose intolerance, Lapp lactose deficiency or glucose - galactose malabsorption.
    3. The patient suffers from severe physical and neurological active disease and /or present history of Neuroleptic Malignant Syndrome.
    4. The patient is suffering from liver dysfunction and / or increased liver enzymes (serum alanine aminotransferase (ALT) and / or aspartamikis aminotransferase (AST) ≥ 1,5 x ULN)
    5. The patient suffers from severe renal impairment (creatinine clearance <30 ml / min)
    6. The patient suffers from epilepsy
    7. The patient is suffering from severe dyskinesia and/or from non - traumatic Rhabdomyolysis or Hyperthermia.
    8. The patient is suffering from pheochromocytoma.
    9. The patient has a previous history of Neuroleptic Malignant Syndrome (NMS).
    10. The patient has suffered a myocardial infarction within the last 6 months.
    11. The patient receives treatment with non - selective inhibitors of mono - amino - oxidase (MAO) inhibitors (eg phenelzine and tranylcypromine). If the patient is treated with a selective inhibitor of MAO –B, it should not exceed the recommended dose (eg for selegiline < 10mg/day) when co-administered with tolcapone .
    12. The patient receives other enzyme inhibitor COMT drugs (e.g. entacapone, clozapine) or other dopaminergic drugs.
    13. The patient is being treated with levodopa and benserazide.
    14. The patient receives or has received in the past another investigational drug, biologic or device within 4 weeks of the preliminary assessment.
    15. The patient receives antipsychotic medication known to exclude D1 receptors with high binding (affinity) such as flupenthixol , fluphenazine , ziprasidone , chlorpromazine , and olanzapine (Ki 4, 6, 30, 35 and 48 respectively).
    16. The patient according to the investigator is unable to meet the requirements of the study.
    17. The patient has a current or recent history of drug or alcohol or shows reluctance to decrease the consumption of alcohol.
    E.5 End points
    E.5.1Primary end point(s)
    Examine the efficacy of tolcapone as add-on therapy on the negative and cognitive symptoms of schizophrenia compared to standard antipsychotic treatment alone
    E.5.1.1Timepoint(s) of evaluation of this end point
    every 6 months
    E.5.2Secondary end point(s)
    Examine the relationship of patients’response to tolcapone according to their COMT genotype.
    E.5.2.1Timepoint(s) of evaluation of this end point
    every 6 months
    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 No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) 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 No
    E.8.1.6Cross over Yes
    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 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
    when 100 have completed the study
    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 months0
    E.8.9.1In the Member State concerned 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: 100
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state100
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 100
    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)
    continue with usual treatment
    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 Decision2014-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-29
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 18 17:12:32 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA