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   43861   clinical trials with a EudraCT protocol, of which   7284   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:2012-005510-20
    Sponsor's Protocol Code Number:C10953/1100
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-03-07
    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 number2012-005510-20
    A.3Full title of the trial
    A Randomized, Open-Label Study to Characterize the Pharmacokinetics, Pharmacodynamics, and Safety of Single and Multiple Doses of Armodafinil (50, 100, and 150 mg/day) in Children and Adolescents with Excessive Sleepiness Associated With Narcolepsy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study in children and adolescents with Excessive Sleepiness Associated With Narcolepsy to assess Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil (experimental drug).
    A.4.1Sponsor's protocol code numberC10953/1100
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01624480
    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 SponsorCephalon, 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 supportTeva Pharmaceutical Industries Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva Pharma GmbH
    B.5.2Functional name of contact pointClinical trial information desk
    B.5.3 Address:
    B.5.3.1Street Address7, Waldeckerstr.
    B.5.3.2Town/ cityMörfelden-Walldorf
    B.5.3.3Post code64546
    B.5.3.4CountryGermany
    B.5.6E-mailinfo.era-clinical@teva.de
    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 Nuvigil
    D.2.1.1.2Name of the Marketing Authorisation holderCephalon, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameArmodafinil
    D.3.2Product code CEP-10953
    D.3.4Pharmaceutical form 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 INNArmodafinil
    D.3.9.1CAS number 112111-43-0
    D.3.9.2Current sponsor codeCEP-10953
    D.3.9.3Other descriptive nameARMODAFINIL
    D.3.9.4EV Substance CodeSUB32249
    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) 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 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
    Excessive Sleepiness associated with Narcolepsy
    E.1.1.1Medical condition in easily understood language
    Excessive Sleepiness associated with Narcolepsy (neurological sleep disorder)
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    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 primary objective of this study is to characterize the single- and multiple-dose pharmacokinetics of armodafinil and its major circulating metabolites (R-modafinil acid and modafinil sulfone) in children and adolescents with excessive sleepiness associated with narcolepsy.
    E.2.2Secondary objectives of the trial
    characterize the safety of armodafinil following single- and multiple-dose administration in children and adolescents with excessive sleepiness associated with narcolepsy as assessed by:
    -occurrence of adverse events (including protocol-defined expedited adverse events)
    -clinical laboratory test results at the final assessment or early withdrawal
    -vital signs measurements
    -resting 12-lead electrocardiogram (ECG) findings at the final assessment or early withdrawal
    -physical examination findings
    -body weight measurements
    -body temperature measurements
    -skin examinations
    -suicidality assessments
    -concomitant medication usage

    to explore the pharmacodynamics of armodafinil following single- and multiple-dose administration
    in children and adolescents with excessive sleepiness associated with narcolepsy as assessed by the
    multiple sleep latency test and the Clinical Global Impression of Change (CGI-C) ratings
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients are included in the study if all of the following criteria are met:
    (a) Written informed consent is obtained from each patient’s parent or legal guardian and written
    assent is obtained from each patient.
    (b) The patient is male or female 6 through 17 years of age with a body mass index (BMI) equal or greater than 10th percentile for age and gender, inclusive.
    (c) The patient has a diagnosis of narcolepsy with cataplexy or narcolepsy without cataplexy according
    to the criteria established by the International Classification of Sleep Disorders (ICSD)-2 for
    narcolepsy (347.0).
    d) The patient is able to swallow 3 placebo tablets that match the armodafinil tablets to be
    administered during the study with up to 240 mL of water within 5 minutes.
    (e) The patient is in good health as determined by a medical and psychiatric history, physical
    examination, ECG, and clinical laboratory tests.
    (f) Inclusion criterion (f) is replaced by (f1)
    (f1) Female patients who are postmenarche or sexually active or who are 10 years of age or older,
    must have a negative pregnancy test prior to the baseline visit, must be using an acceptable method
    of contraception, and agree to continued use of this method for the duration of the study and for
    30 days after discontinuation of study drug. Acceptable methods of contraception include
    abstinence or an intrauterine device (known to have a failure rate of less than 1% per year).
    (g) The patent has a negative alcohol test and urine drug screen (UDS).
    (h) The patient and parent/legal guardian must be willing and able to comply with study restrictions
    and to remain at the clinic for the required duration at each visit.
    E.4Principal exclusion criteria
    The patient has
    -any clinically significant uncontrolled medical condition other than narcolepsy.
    -clinically significant deviation from normal in ECG, physical examination or vital sign findings as determined by the investigator or medical monitor
    -patient is pregnant or lactating
    patient has
    -any history of seizures, including febrile seizures, or a family history of seizures which is not a consequence of trauma, stroke, or metabolic disturbance.
    -history of head trauma associated with loss of consciousness
    -current suicidal ideation, history of suicidal ideation, or history of suicide attempt.
    -history of major depressive disorder, bipolar disorder, other significant mood disorders, schizophrenia and other psychotic disorders, eating disorders or has family history of suicide.
    -left ventricular hypertrophy or patient has mitral valve prolapse and has experienced mitral valve prolapse syndrome
    -received any investigational drug within 30 days or 5 half-lives (whichever is longer) before the 1st dose of study drug, or in the case of a new chemical entity, 3 months or 5 half-lives (whichever is longer) before 1st dose of study drug
    -used any monoamine oxidase inhibitors or stimulants within 14 days or 5 halflives (whichever is longer) of the baseline visit
    -used modafinil or armodafinil within 4 weeks of the baseline visit
    -used inducer of cytochrome P450 enzyme 3A4/5 within 28 days prior to study drug administration
    -used inhibitor of CYP3A4/5 within 14 days or 5 halflives (whichever is longer) prior to study drug administration
    -habitually consumed, within past 12 month, more than 21 units of alcohol per week, or has history of alcohol, narcotic, or any other substance abuse as defined by the Diagnostic and Statistical Manual of Mental Disorder, Fourth Edition, Text Revision (DSM-IV-TRAmerican Psychiatric Association 2000).
    -any disorder that may interfere with drug absorption, distribution, metabolism, or excretion
    -known sensitivity or idiosyncratic reaction to any compound present in modafinil or armodafinil, their related compounds, or to any metabolites or compound listed as being present
    in these medications
    -history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reactions
    -donated blood or had significant blood loss within 56 days prior to 1st dose of study drug
    -donated plasma within 7 days prior to the 1st dose of study drug
    -1 or more clinical laboratory test values outside the range specified below, or any other clinically significant laboratory abnormality as determined by the investigator or medical monitor:
    hemoglobin value of less than 11.0 g/dL, aspartate aminotransferase or alanine aminotransferase value more than twice the upper limit of the normal range (ULN), total bilirubin value of more than the ULN
    -had a clinically significant excessive consumption of coffee, tea, and/or other
    caffeine-containing beverage or food within 2 weeks before 1st dose of study drug, consumption
    of 600 mg of caffeine or more per day (eg, twelve 12-ounce caffeinated sodas, 30 ounces of
    chocolate, or 5 or more cups of coffee per day)
    -had, within 4 weeks before 1st dose of study drug, clinically significant illness or, within 1 week before 1st dose of study drug, has had any acute illness, or at screening or on the day before 1st study drug administration, has symptoms of any clinically significant or acute illness
    -pos. test result for hepatitis B surface antigen or antibodies to hepatitis C, or had known pos. human immunodeficiency virushistory
    -patient is a user or former user of nicotine-containing products who stopped use or consumption of these nicotine-containing products less than 3 months before study drug administration or is using or has used topical or oral nicotine preparations for smoking cessation
    within the past 3 months before study drug administration
    -patient is unlikely to comply with study protocol, or is unsuitable for any other reasons, as judged by the investigator
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to characterize the single- and multiple-dose
    pharmacokinetics of armodafinil and its major circulating metabolites (R-modafinil acid and modafinil
    sulfone) in children and adolescents with excessive sleepiness associated with narcolepsy
    E.5.1.1Timepoint(s) of evaluation of this end point
    throughout study:
    -occurrence of adverse events (including protocol-defined expedited
    adverse events)
    -vital signs measurements
    -physical examination findings
    -body weight measurements
    -body temperature measurements
    -skin examinations
    -suicidality assessments
    -concomitant medication usage

    at final assessment or early withdrawal:
    -clinical laboratory test results
    -resting 12-lead electrocardiogram findings
    explore pharmacodynamics of armodafinil following single and multiple
    dose administration

    please see protocol for more details
    E.5.2Secondary end point(s)
    The secondary objectives of the study are as follows:
    • to characterize the safety of armodafinil following single- and multiple-dose administration in
    children and adolescents with excessive sleepiness associated with narcolepsy as assessed by:
    ― occurrence of adverse events (including protocol-defined expedited adverse events) throughout
    the study
    ― clinical laboratory test results at the final assessment or early withdrawal
    ― vital signs measurements throughout the study
    ― resting 12-lead electrocardiogram (ECG) findings at the final assessment or early withdrawal
    ― physical examination findings throughout the study
    ― body weight measurements throughout the study
    ― body temperature measurements throughout the study
    ― skin examinations throughout the study
    ― suicidality assessments throughout the study
    ― concomitant medication usage throughout the study
    • to explore the pharmacodynamics of armodafinil following single- and multiple-dose administration
    in children and adolescents with excessive sleepiness associated with narcolepsy as assessed by the
    multiple sleep latency test (MSLT) and the Clinical Global Impression of Change (CGI-C) ratings
    E.5.2.1Timepoint(s) of evaluation of this end point
    throughout study:occurrence of adverse events, vital signs measurements, physical examination findings, body weight measurements, body temperature measurements, skin examinations, suicidality assessments, concomitant medication usage.
    at final assessment or early withdrawal:
    -clinical laboratory test results
    -resting 12-lead electrocardiogram findings
    explore pharmacodynamics of armodafinil following single and multiple dose administration in children and adolescents with excessive sleepiness associated with narcolepsy as assessed by multiple sleep latency test and Clinical Global Impression of Change ratingsin children and adolescents with excessive sleepiness associated with narcolepsy as assessed by multiple sleep latency test and Clinical Global Impression of Change ratings
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    characterization of Pharmacokinetics, Pharmacodynamics and Safety in Children and Adolescents
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Finland
    United States
    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
    LVLS
    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 years2
    E.8.9.2In all countries concerned by the trial months3
    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.1.1Number of subjects for this age range: 45
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 25
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2013-03-07. Yes
    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 under age 15.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 45
    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)
    None
    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 Decision2013-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-27
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    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-Fri Apr 26 02:29:39 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA