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    Summary
    EudraCT Number:2008-005098-37
    Sponsor's Protocol Code Number:CARISEPY3013/3014
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-09-19
    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 ConcernedFinland - Fimea
    A.2EudraCT number2008-005098-37
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Carisbamate as Adjunctive Therapy in Subjects With Partial Onset Seizures, Followed by an Open-Label Extension Study
    A.4.1Sponsor's protocol code numberCARISEPY3013/3014
    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 SponsorJanssen Cilag International, NV
    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 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 nameCarisbamate
    D.3.2Product code RWJ-333369
    D.3.4Pharmaceutical form Film-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.3.9.2Current sponsor codeRWJ-333369
    D.3.9.3Other descriptive nameCarisbamate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 600
    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 placeboFilm-coated 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
    Epilepsy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10015037
    E.1.2Term Epilepsy
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of this study are to compare the efficacy, safety, and tolerability of carisbamate as adjunctive treatment of partial onset seizures, relative to placebo, as measured by the:
    -Percent reduction in partial onset seizure frequency from baseline relative to the entire double blind treatment phase.
    -Responder rate from baseline relative to the entire double-blind treatment phase.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    -To evaluate the effect of carisbamate on percent reduction in partial onset seizure frequency from baseline relative to the entire double blind treatment phase for registration in the countries of Europe, Australia, New Zealand, and South Africa
    -To evaluate the effect of carisbamate on percent reduction in secondarily generalized seizures from baseline relative to the entire double blind treatment phase
    -To evaluate the time to onset of treatment effect of carisbamate on partial onset seizure frequency reduction
    -To characterize the pharmacokinetics of carisbamate using a limited sampling strategy, in which all subjects will participate, followed by population pharmacokinetic (PK) analyses. The potential impact of carisbamate on the trough concentrations of select concomitant AEDs will also be assessed.

    Overall safety and tolerability of carisbamate will be evaluated.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Male or female 16 years of age or older
    -Weight of at least 40 kg
    -Established diagnosis of partial onset seizures, including simple partial motor, complex partial, or secondarily generalized seizures, for at least 1 year using the International League Against Epilepsy (ILAE) criteria (ILAE 1989) Note: Seizures must be adequately classified as partial onset seizures.
    -Must have had a neuroimaging procedure within 5 years, including a computed tomography (CT) scan or magnetic resonance imaging (MRI), that excluded a progressive neurologic disorder; these procedures may be performed within the 56-day baseline period
    -History of inadequate response to at least 1 AED, administered at the appropriate dosage(s) and for a sufficient treatment period, based on the judgment of the investigator (subject may be currently treated with this therapy). Subjects with a history of 10 or more generalized seizures (of any type) per month should have exhibited inadequate response to at least 3 prior AEDs.
    -Current treatment with at least 1 and up to 3 AEDs, administered at stable dosage(s) for at least 1 month before screening, and no new AEDs added for the previous 2 months; these AEDs must remain unchanged throughout the pretreatment and double-blind treatment phases (with the exception of dosage reductions of concomitant AEDs because of suspected elevated AED levels or side effects) Note: One-time changes in AED dosages do not represent a change in the daily AED regimen. For example, if the subject took an extra dose of an AED on one day, this would not represent a change in the daily AED regimen. Benzodiazepines received on a continuing basis at stable dosages for 1 month before screening should be considered as concomitant AEDs.
    -Females must be: Postmenopausal (for at least 2 years), Surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), Abstinent (at the discretion of the investigator/per local regulations), or if sexually active, be practicing an effective method of birth control
    - All women must have a negative urine pregnancy test at screening and at the time of randomization on Day 1.
    -Negative urine drug screen (except for prescription benzodiazepines, prescription barbiturates, or prescription narcotics) at screening
    -Negative urine alcohol test at screening
    -Willing/able to follow the prohibitions and restrictions specified in this protocol
    -Willing/able to complete the subject diaries correctly (subjects or legally acceptable representatives)
    -Subjects (or their legally acceptable representatives) must have signed an informed consent form indicating that they understand the purpose of and the procedures required for the study and are willing to participate in this study. Assent is also required of adolescents capable of understanding the nature of the study, as described in the protocol. Note: Subjects with cognitive impairment may be enrolled in this study. The investigator will determine each subject’s capacity to provide informed consent. When cognitive impairment brings a subject’s capacity into question, the investigator will obtain informed consent and assent from the cognitively impaired subject, and consent from the legally acceptable representative(s) in accordance with all applicable local regulations.
    E.4Principal exclusion criteria
    -History of status epilepticus or epilepsia partialis continua in the 6 months before study entry. Status epilepticus is defined as sequential seizures without full recovery of consciousness between seizures, or more than 30 minutes of continuous seizure activity
    -Have a generalized epileptic syndrome
    -Diagnosis of Lennox-Gastaut Syndrome
    -Currently experiencing seizures that cannot be counted accurately, for example, because of the following reasons: Extreme frequency or clustering, Lack of clear onset and cessation between seizures, Lack of informant to provide a seizure count when the subject is unable to independently recall
    -Have experienced rates of 100 or more partial onset seizures in any monthly period in the 6 months before study entry
    -History of any current or past nonepileptic seizures, including psychogenic seizures
    -History of or current serious or medically unstable systemic disease, including clinically apparent liver disease, renal insufficiency, a malignant neoplasm (except treated non-melanoma skin cancer), diabetes requiring insulin, or any disorder which in the judgment of the investigator will place the subject at excessive risk if participating in a controlled study.
    -Clinical evidence of cardiac disease, including unstable angina, myocardial infarction, within the past 2 years, uncontrolled heart failure, major arrhythmias, congenital short QT syndrome, or significant shortening or lengthening of the QTcF (Fridericia’s correction) intervals (<330 ms or >500 ms)
    -Progressive neurologic disorder, such as a brain tumor, demyelinating disease, and degenerative CNS disease, or active CNS infection
    -Current or past (within the past year) major psychotic disorder, such as schizophrenia, bipolar disorder, or other psychotic conditions, recent (within the past 6 months) interictal psychosis, and Major Depressive Disorder with psychotic features
    -Exacerbation of Major Depressive Disorder within the past 6 months; antidepressant use is allowed
    -History of suicidal or homicidal ideation within the past 2 years, or an episode of suicide attempt or homicide at any time in the past
    -History of drug or alcohol abuse within the past year
    -Current treatment with vagus nerve stimulation (VNS) for 1 year or less duration
    -Planned epilepsy surgery within the next 6 months
    -Currently on a ketogenic diet
    E.5 End points
    E.5.1Primary end point(s)
    Responder rate:

    The primary efficacy endpoint is the responder rate, the proportion of subjects with 50% reduction in partial onset seizure frequency (average seizure rate per 28 days of all simple partial motor, complex partial, or secondarily generalized seizures) from baseline relative to the entire double-blind treatment phase.
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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
    Tolerability
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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
    In addition to ICF, assent is required of adolescents capable of understanding the nature of the study, as described in the protocol as well as subjects with cognitive impairment, as determined by the investigator.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 174
    F.4.2.2In the whole clinical trial 600
    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 Decision2008-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-08-31
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