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    The EU Clinical Trials Register currently displays   44020   clinical trials with a EudraCT protocol, of which   7318   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).

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    Summary
    EudraCT Number:2007-005439-27
    Sponsor's Protocol Code Number:SP902
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-09-09
    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 ConcernedIreland - HPRA
    A.2EudraCT number2007-005439-27
    A.3Full title of the trial
    A Historical-controlled, Multicenter, Double-blind, Randomized Trial to Assess the Efficacy and Safety of Conversion to Lacosamide 400mg/day Monotherapy in Subjects with Partial-onset Seizures
    A.3.2Name or abbreviated title of the trial where available
    ALEX-MT (A Lacosamide EXchange to Monotherapy Trial)
    A.4.1Sponsor's protocol code numberSP902
    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 SponsorSCHWARZ BIOSCIENCES, 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 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 nameLacosamide
    D.3.2Product code SPM 927
    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.3.8INN - Proposed INNLacosamide
    D.3.9.1CAS number 175481-36-4
    D.3.9.2Current sponsor codeSPM 927
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.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 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 nameLacosamide
    D.3.2Product code SPM 927
    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.3.8INN - Proposed INNLacosamide
    D.3.9.1CAS number 175481-36-4
    D.3.9.2Current sponsor codeSPM 927
    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) 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
    Partial-onset seizures (with or without secondary generalization)
    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
    The objective of this trial is to demonstrate the efficacy and safety of conversion to LCM 400mg/day monotherapy for partial-onset seizures (with or without secondary generalization) in subjects 16 to 70 years of age who are withdrawn from 1 to 2 marketed AEDs.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent.
    2. Subject is willing and able to comply with all trial requirements.
    3. Subject is male or female between the age of 16 and 70 years of age, inclusive.
    4. Subject has a diagnosis of epilepsy with simple partial seizures (motor component) and/or complex partial seizures (with or without secondary generalization) according to the International Classification of Epileptic Seizures, 1981.
    5. Subject has been maintained on a stable dose of 1 or 2 marketed AEDs for at least 28 days prior to Visit 1 and during Baseline.
    6. If a subject is on 2 AEDs, the second AED must be ≤50% of the minimum effective recommended dose per USA product label at Visit 1 and during Baseline when used as an adjunctive therapy.
    7. The minimum required seizure frequency during the 8-week Baseline Phase is 2 partial-onset seizures (IA, IB, or IC) per 28 days. In the case of simple partial seizures, only those with motor signs (IA1) will be counted towards meeting this inclusion criterion. (See Section 15.2, International Classification of Epileptic Seizures, 1981.)
    8. Subject has ≤ 40 partial seizures (ie, IA1, IA2, IA3, IA4, IB, IC) per 28 days during the 8-week Baseline Phase. (See Section 15.2, International Classification of Epileptic Seizures, 1981.)
    9. Subject has had an electroencephalogram and a brain computerized tomography scan or magnetic resonance imaging exam of the brain consistent with the diagnosis of partial-onset epilepsy.
    E.4Principal exclusion criteria
    1. Subject has previously participated in this trial or subject has previously been assigned to treatment in a trial of the drug under investigation in this trial.
    2. Subject is currently participating or has participated within the last 2 months in any trial of an investigational drug or experimental device.
    3. Subject has a seizure disorder characterized primarily by isolated auras (ie, simple partial seizures without observable motor signs).
    4. Subject has a history of primary generalized or unclassified seizures.
    5. Subject has a history of status epilepticus within the 12-month period prior to Visit 1.
    6. Subject has a history of cluster seizures, defined as bouts of increased seizures which cannot be reliably counted (but which do not represent status epilepticus) during the 8-week period prior to Visit 1 and during the 8-week Baseline Phase.
    7. Subject has a seizure-free period ≥28 consecutive days during the 8-week Baseline Phase.
    8. Subject has >5 seizures of any type, including isolated auras, on any day during the 8-week period prior to Visit 1 and during the 8-week Baseline Phase.
    9. Subject has a current or previous diagnosis of pseudoseizures, conversion disorders, or other non-epileptic ictal events which could be confused with seizures. 10. Subject has ever received VNS.
    11. Subject has received treatment with benzodiazepines, phenobarbital, or primidone within 28 days prior to Visit 1 or during Baseline.
    12. Subject is taking 1 or more of the following medications on a regular basis within 28 days prior to Visit 1 or during Baseline: neuroleptics, monoamine oxidase (MAO) inhibitors, barbiturates, or narcotic analgesics.
    13. Subject has any medical or psychiatric condition, which in the opinion of the investigator, could jeopardize the subject’s health or would compromise the subject’s ability to participate in this trial.
    14. Subject has a history of suicide attempts or has experienced suicidal ideation in the past 5 years.
    15. Subject has a known hypersensitivity to any components of the investigational product(s) as stated in Section 4.4.2.
    16. Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism or excretion.
    17. Subject has any history of alcohol or drug abuse within the previous 2 years.
    18. Subject has an acute or sub-acutely progressive central nervous system disease.
    19. Subject with a known history of severe anaphylactic reaction or serious blood dyscrasias.
    20. Subject weighs <40kg.
    21. Subject has alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels ≥2 times the upper limit of normal (ULN) or has alkaline phosphatase levels ≥3 times the ULN at Visit 1.
    22. Subject has impaired renal function, ie, creatinine clearance (CLcr) is lower than 50 mL/minute, at Visit 1. Creatinine clearance will be estimated by the central laboratory as follows: Adult males: CLcr = (140-age) x weight in kg/(72 x serum creatinine in mg/dL) Adult females: CLcr = [(140-age) x weight in kg/(72 x serum creatinine in mg/dL)] x 0.85.
    23. Subject has diastolic blood pressure <50mmHg or >105mmHg at Visit 1, measured in a sitting position after 3 minutes of rest.
    24. Subject has a heart rate <50 beats per minute (bpm) or >110bpm at Visit 1, based on a central cardiologist over-read.
    25. Subject has sick sinus syndrome without a pacemaker.
    26. Subject has experienced a myocardial infarction in the last 12 months.
    27. Subject has New York Heart Association Class III or Class IV heart failure.
    28. Subject has atrial fibrillation/flutter, ventricular tachyarrhythmia (eg, ventricular tachycardia, ventricular fibrillation, aborted cardiac arrest), or symptomatic heart block or is diagnosed with Brugada syndrome.
    29. Subject has confirmed clinically relevant abnormality in electrocardiogram (ECG), including prolonged QTc (Bazett’s, based on a central cardiologist over-read) interval defined as ≥470ms at Visit 1, or known conduction problems (ie, second degree or higher atrioventricular block).
    30. Subject is a pregnant female, nursing woman and/or a female of childbearing potential who is not surgically sterile, 2 years postmenopausal, or does not practice 2 combined methods of contraception (unless sexually abstinent) for the duration of the trial.
    31. Subject has ever received treatment with felbamate, ethosuximide, or vigabatrin.
    32. Subject is on a ketogenic diet.
    E.5 End points
    E.5.1Primary end point(s)
    The percentage of subjects who are identified as meeting at least 1 of the following exit criteria by Day 112 relative to the start of the withdrawal of background AEDs is considered the primary efficacy variable.
    1. A 2-fold or greater increase in average monthly (28-day) partial seizure frequency (motor and non-motor) compared to average monthly partial seizure frequency (motor and non-motor) during the Baseline Phase.
    Note: a 28-day seizure frequency of <1.5 is not expected based on inclusion criteria for the trial. However, if it should occur that the 28-day seizure frequency during the Baseline Phase is <1.5, a 28-day partial seizure frequency of ≥3 is required to meet this exit criterion.
    2. A 2-fold or greater increase in consecutive 2-day partial seizure frequency (motor and non-motor) versus the highest consecutive 2-day partial seizure frequency (motor and non-motor) that occurred during the Baseline Phase.
    Note: if the highest consecutive 2-day partial seizure frequency during the Baseline Phase is 1, a 2-day partial seizure frequency of ≥3 is required to meet this exit criterion.
    3. Occurrence of a single generalized tonic-clonic seizure if none had occurred in the 6 months prior to randomization.
    4. A prolongation or worsening of overall seizure duration, frequency, type or pattern considered by the investigator as serious enough to warrant trial discontinuation.
    5. Status epilepticus, or new onset of serial/cluster seizures.
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.7.1Other trial design description
    Historical-controlled
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Lacosamide 300 mg/day and Historical Controlled Trials
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 357
    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)
    Subjects will either be enrolled in the open label extension trial SP904 (EudraCT number 2007-005440-25) or be treated by the investigator or their regular physician in accordance with current best clinical practise with existing treatments.
    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 Opinion2008-11-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-12-06
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