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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35239   clinical trials with a EudraCT protocol, of which   5761   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).
     
    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:2004-001302-27
    Sponsor's Protocol Code Number:N01142
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-03-03
    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 ConcernedGermany - BfArM
    A.2EudraCT number2004-001302-27
    A.3Full title of the trial
    An 8-week exploratory, double-blind, placebo controlled, randomized trial :
    Evaluation of the efficacy and safety of levetiracetam up to 3000 mg/day (250-500 mg oral tablets in b.i.d. administration) on neuroleptic-induced tardive dyskinesia in subjects with stable axis I psychiatric disorder, aged from at least 18 years to 80 years.
    A.3.2Name or abbreviated title of the trial where available
    Tardive Dyskinesia-Levetiracetam
    A.4.1Sponsor's protocol code numberN01142
    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 SponsorUCB S.A. Pharma Sector
    B.1.3.4CountryBelgium
    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 Information not present in EudraCT
    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 nameLevetiracetam
    D.3.2Product code ucb L059
    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.3.8INN - Proposed INNLevetiracetam
    D.3.9.1CAS number 102767-28-2
    D.3.9.2Current sponsor codeucb L059
    D.3.9.3Other descriptive nameS-enantiomer of α-ethyl-2-oxo-1-pyrrolidine acetamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 nameLevetiracetam
    D.3.2Product code ucb L059
    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.3.8INN - Proposed INNLevetiracetam
    D.3.9.1CAS number 102767-28-2
    D.3.9.2Current sponsor codeucb L059
    D.3.9.3Other descriptive nameS-enantiomer of α-ethyl-2-oxo-1-pyrrolidine acetamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Tardive dyskinesia usually occurs after prolonged exposure to antipsychotics and is characterized by abnormal choreiform, athetoic, choreathetoic or rhythmic involuntary movements.
    The localizations of the neuroleptic-induced TD are mostly the tongue, jaw or extremities.
    The abnormal movements increase with emotional arousal and decrease with relaxation. The movements are absent during sleep.




    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.1
    E.1.2Level LLT
    E.1.2Classification code 10013928
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of levetiracetam up to 3000 mg/day in b.i.d. administration to placebo during an 8-week treatment period in the treatment of neuroleptic-induced tardive dyskinesia in subjects aged at least 18 years to 80 years with a stable axis I psychiatric disorder.
    E.2.2Secondary objectives of the trial
    •To compare the efficacy of levetiracetam up to 3000 mg/day in b.i.d. administration to placebo on neuroleptic-induced akathisia and other extrapyramidal symptoms.

    •To evaluate the effect of levetiracetam up to 3000mg/day in b.i.d. administration on the primary psychiatric disorder compared to placebo.

    •To evaluate the safety of levetiracetam.

    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    •Written informed consent signed and dated by the subject.
    •Male or female, age ≥18 and ≤ 80 years.
    •In- or out patients
    •Diagnosis of stable Axis I psychiatric disorder according to the Investigator since at least 6 months prior to the screening visit (V1).
    •Stable Neuroleptic-Induced Tardive Dyskinesia (NITD) according to the DSM-IV criteria since at least 1 month prior to the screening visit (V1).
    •Tardive Dyskinesia severity defined by a total mean score of hyperkinesia on the SHRS of at least 5 at screening visit (V1) and at baseline visit (V2) before randomization.
    •Use of antipsychotics (all types and routes of administration) for at least 6 cumulative months prior to the screening visit (V1) and, if the subject is under treatment, at least one month on a stable dose regimen prior to the screening visit (V1).
    •If applicable, stable dose regimen of anticholinergic agents and other drugs used for abnormal movement disorders for the last month prior to the screening visit (V1).
    •Able to cooperate and to communicate adequately as judged by the investigator.
    •Subjects willing to be videotaped.
    •Female subjects without childbearing potential (premenarchal, 2 years post-menopausal, bilateral oophorectomy or bilateral salpingectomy, complete hysterectomy, congenital sterility, bilateral tubal ligation) are eligible. Female subjects with childbearing potential are eligible if they have a negative serum pregnancy test at the screening visit (V1) and if they use a medically accepted contraceptive method for the duration of the trial participation (i.e. oral or non-oral contraceptive method, intra-uterine device, diaphragm with spermicide, male condom with spermicide, female condom, monogamous relationship with vasectomized partner). Abstinence will be considered as an acceptable method of contraception on a case-by-case basis upon discussion with the UCB Clinical Research Physician (CRP) or his/her representative. The subject must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive methods, and undertake to inform the Investigator of any potential change in status.

    E.4Principal exclusion criteria
    •Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method.
    •The presence of any Axis II condition within 6 months prior to the screening visit (V1).
    •History of suicide attempts during the last 10 years prior to the screening visit (V1).
    •Huntington’s disease, idiopathic dystonia, Wilson’s disease, Sydenham’s chorea, thyroid dysfunction or spontaneous dyskinesia.
    •Dyskinesia due to ill-fitting denture.
    •Start of drugs (other than neuroleptics) that can cause dyskinesia (e.g. L-dopa, bromocriptine) within one month prior to the screening visit (V1).
    •The presence of alcohol, or other substance abuse disorder as defined by DSM-IV.
    •Any medication that may interfere with the absorption, distribution, metabolism, or excretion of the concomitant neuroleptics or levetiracetam during the course of the study.
    •Introduction or change in the dose of anticholinergic agents or other drugs intended to control abnormal movements disorders (i.e. branched chain amino acids, vitamin B6 or E, melatonin, neuroleptics,...) within the last month prior to the screening visit (V1).
    •Benzodiazepine use not stable i.e. more than 50% change in the daily dose for more than 3 days in subjects with daily benzodiazepine intake, since at least 2 weeks prior to the screening visit (V1).
    •Any participation in an investigation of a medication or device within 3 months prior to the screening visit (V1) or during this trial.
    •Subject has clinically significant deviations from reference range values for renal function (creatinine clearance – estimated with Cockroft formula - below 50 ml/min) or any of the other laboratory parameters required for this study, as assessed by the Investigator.
    •Clinically significant ECG abnormalities;
    •Subject has any clinically significant acute or chronic illness (i.e. cardiac, renal or hepatic disease) (as determined during the physical examination or from other information available to the Investigator).
    •Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients (not exclusively but principally to lactose, corn starch, and cellulose) or known history of multiple drug allergies.
    •Subject is known to have a terminal illness.
    •Subject has any medical condition that might interfere with the subject’s study participation (i.e., serious infection, scheduled elective surgery, etc).
    •History of poor compliance with visit schedule or medication intake.
    •Investigators, co-investigators, their spouses or children or any trial collaborators may not be included as subject in the trial.
    •Subjects having been blood donors during the 3 months before V1 or planning to be blood donator during the trial.
    •Subject previously allocated to a trial treatment within this trial.


    E.5 End points
    E.5.1Primary end point(s)
    Criteria for evaluation :
    Efficacy Variables
    •The primary efficacy variable is the change from baseline on the total mean score of hyperkinesia estimated at the evaluation visit (V6) as evaluated by the independent blinded central reviewer.

    All analyses on the SHRS will be performed on the ratings by the independent blinded central reviewer unless specified otherwise.
    The secondary efficacy variables are the following variables:
    •The change from baseline on the total mean score of hyperkinesia estimated at the evaluation visit (V6) as evaluated by the investigators.
    •The change from baseline on the individual SHRS items and subtotals.
    •Changes from baseline on the total mean score of hyperkinesia at the evaluation visit (V6) will be evaluated by subdividing the subjects into the following categories :
    •Subjects with ≥4 points decrease
    •Subjects with 3 points or less change (either increase or decrease).
    •Subjects with an increase of 4 points or more.
    •Subjects with a decrease of at least 50% on the total mean score of hyperkinesia at the evaluation visit (V6) compared to baseline.
    •Time evolution of the percent reduction from baseline in the total mean score of hyperkinesia.
    •The subjects' maximum improvement/worsening over time on the individual SHRS items and subtotals.
    •Time evolution of the BPRS.
    •Investigator’s GES’s.

    Exploratory Variables
    •Correlations between the scores from the Investigator rated scales and the scores from the independent blinded central reviewer will be explored.

    Safety Variables
    •Adverse events (AEs);
    •Laboratory tests;
    •Physical and neurological examinations;
    •Vital signs;
    •Body weight;
    •Electrocardiogram (ECG);
    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 Information not present in EudraCT
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 trial is defined as the date of database lock as, at that time, interactions between the Sponsor and the Investigator(s) with possible impact on subjects data have ended.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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) 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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state21
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 70
    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 Decision2005-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-03-18
    P. End of Trial
    P.End of Trial StatusCompleted
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA