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    Summary
    EudraCT Number:2007-000897-21
    Sponsor's Protocol Code Number:N01280
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-10-31
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2007-000897-21
    A.3Full title of the trial
    A multi-center, double-blind, historical control, randomized conversion to monotherapy study with Keppra XR for treatment of partial onset seizures
    A.4.1Sponsor's protocol code numberN01280
    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, Inc.
    B.1.3.4CountryUnited States
    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 Yes
    D.2.1.1.1Trade name Keppra (Levetiracetam)
    D.2.1.1.2Name of the Marketing Authorisation holderUCB Pharma SA
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameKeppra XR
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNLEVETIRACETAM
    D.3.9.1CAS number 102767282
    D.3.9.3Other descriptive nameKeppra XR
    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 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 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
    partial onset seizures
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level HLGT
    E.1.2Classification code 10039911
    E.1.2Term Seizures (incl subtypes)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of Keppra XR compared with a historical control, in the conversion to monotherapy treatment of partial onset seizures.
    E.2.2Secondary objectives of the trial
    Secondary objective:
    To assess the safety and tolerablity of two doses of Keppra XR, in the conversion to monotherapy treatment of partial onset seizures.

    Exploratory objective:
    To explore the direct medical resource use and indirect cost parameters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female subjects 12 to 75 years of age
    Signed and dated written informed consent. Signed and dated written assent, if applicable.
    Subjects must have inadequately controlled partial onset epilepsy with observable partial seizures that may be classified as simple complex or partial seizures evolving to secondary generalized seizures according to ILAE classification
    Subjects must be experiencing 2 to 40 seizures per 4-week period while being maintained on at least one, but no more than two standard AEDs, and auras are not being included in the seizure count.
    Subjects must be on a stable dose for at least four weeks before Screening (Visit 1) of at least one, but no more than two other concomintant antiepileptic drugs (AEDs)
    If taking two AEDs, one of the baseline AEDs should be taken at less than or equal to 50% of the minimum recommended dose
    EEG must be consistent with localization related epilepsy
    Previous CT scan or MRI confirming the subject is free of neoplasia, progressive cerebral disease or any other progressively neurodegenerative disease
    Female subjects without childbearing potential are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method. The subjects must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive method, and undertake to inform the Investigator of any potential change in status.
    Subjects must be capable of understanding and completing diaries and adhering to the protocol
    E.4Principal exclusion criteria
    Females who are lactating or pregnant
    A history of status epilepticus in the 6 months preceeding randomization
    Seizures that are uncountable due to clustering during the 8-week period prior to Screening (Visit 1) and during the 8-week Baseline Period
    Significant medical, psychiatric or neurological illness
    Benzodiazepine use
    Suspected substance or alcohol abuse within 12 months preceding randomization
    Use of any medication (other than concomitant AEDs) that influences the central nervous system (CNS) unless on a stable regimen for at least 4 weeks prior to Screening
    History of previous treatment with levetiracetam or sensitivity to levetiracetam
    Use of an investigational drug or device in the 4 months preceding randomization
    Subjects may not enter the study if they are presently receiving phenobarbital, mysoline, or felbamate, or have an activated VNS device
    Neuroleptics and traditional herbal AEDs are not allowed
    History of recurrent psychotic or major affective disorder or suicide attempts
    History or presence of pseudoseizures
    Subjects on ketogenic diet
    Subjects with digestive problems that could impair the absorption of the Keppra XR formulation
    History of poor compliance with visit schedule or medication intake
    Subjects taking part in another clinical/pharmacological study in the 30 days prior to Screening (Visit 1)
    Subjects with any medical or surgical condition that might interfere with the subject's study participation, i.e. scheduled elective surgery, etc.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the cumulative exit rate at 112 days after the beginning of the previous AED tapering phase. Subjects will be required to exit the study if they experience any of the following protocol-defined exit events: 1) a twofold increase in partial seizure frequency in any 4-week treatment period compared to baseline; 2) a twofold increase in the highest 2-day consecutive seizure frequency that occured during the baseline phase; 3) occurance of a generalized seizure if none had occured in the 6 months prior to randomization; or 4) an episode of status epilepticus of a prolongation or worsening of seizure duration or frequency considered by the investigator to require intervention.
    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 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) 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 No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    historical control
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned10
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA10
    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 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
    *Subjects who qualify can enter the long term follow-up study N01281.
    The end of the subject's participation in the study will be confirmed on the CRF. All data about the subject's status (study completion or reason for early termination) at the end of the study will be recorded. It will be specified:
    -Whether the subject completed or discontinued the study.
    -Whether their is still and unresolved AE at the end of 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 months5
    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 months5
    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 Yes
    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) Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children 12-17
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 223
    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)
    Patients who qualify will be allowed to continue treatment under the follow study NO1281 Eudract Number 2007-000899-17
    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 Decision2008-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-09-14
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