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    Summary
    EudraCT Number:2009-014545-83
    Sponsor's Protocol Code Number:C10953/3067/ES/MN
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-03-18
    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 number2009-014545-83
    A.3Full title of the trial
    A 12-week, randomized, double-blind, placebo-controlled, parallel-group. fixed-dosage study to evaluate the efficacy and safety of armodafinil (50, 150, and 250 mg/day) as treatment for patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury
    A.3.2Name or abbreviated title of the trial where available
    C10953/3067/ES/MN
    A.4.1Sponsor's protocol code numberC10953/3067/ES/MN
    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 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 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 nameArmodafinil
    D.3.2Product code CEP-10953
    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 INNArmodafinil
    D.3.9.1CAS number 112111-43-0
    D.3.9.2Current sponsor codeCEP-10953
    D.3.9.3Other descriptive nameR-modafinil
    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.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
    Patients with excessive Sleepiness associated with mild or moderate closed Traumatic Brain Injury (TBI)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10060690
    E.1.2Term Traumatic brain injury
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10015595
    E.1.2Term Excessive daytime sleepiness
    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 the sudy is to determine whether armodafinil treatment is more effective than placebo treatment in patients with excessive sleepiness associated with mild or moderate closed traumatic brain injury (TBI) by measuring mean sleep latency from the Multiple Sleep Latency Test (MSLT) (20-minute version; average of 4 naps at 0900, 1100, 1300, abd 1500) and proportion of responders (patients who are much or very much improved) according to the Clinical Global Impression of Change (CGI-C) ratings relating to excessive sleepiness at week 12 (or last postbaseline observation).
    E.2.2Secondary objectives of the trial
    • to evaluate health-related quality of life in patients assessed by the TBI-WIS at w 4, 8, 12
    • to evaluate the effect of armodafinil treatment on excessive sleepiness:
    mean sleep latency from the MSLT assessed at w 4, 8, 12 (average of 4 naps), CGI-C at w 2, 4, 8, 12, ESS scores at w 12
    • to evaluate the overall safety and tolerability of armodafinil during 12 weeks of double-blind treatment:
    AEs, clinical laboratory tests at w 4, 8, 12, vital signs at w 2, 4, 8, 12, physical examinations, incll skin examinations and body weight, at w 12, ECG at w 12 (or last postbaseline observation), concomitant medication, suicidal ideation and behaviour (C-SSRS-SLV scale) at w 2, 4, 8, 12, symptoms of depression (S-HAM-D6 scale) at w 2, 4, 8, 12
    • to evaluate the effect of treatment on nighttime sleep as assessed by NPSG at w 2, 4, 12 (or last postbaseline observation)
    • to evaluate impact of treatment on pharmacokinetics of SSRIs an SNRIs at w 4, 8, 12
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - mild (Glasgow Coma Scale [GCS] score 13-15) or moderate (GCS 9-12) closed TBI at the time of injury, and injury occurred 1 to 10 years prior to screening. TBI is defined as traumatically induced physiologic disruption of brain function as manifested by 1 of the following:
    any period of LOC, any loss of memory for events immediately before or after the accident, any alteration of mental state, focal neurological deficits (may or may not be transient)
    - the patient has a Glasgow Outcome Scale score of 5 at the screening visit
    - the patient has an ESS score of at least 10 at screening
    - the patient has a mean sleep latency on the MSLT (average of 4 naps) of less than 8 minutes at baseline
    - the patient has a Clinical Global Impression of Severity of Illness (CGI-S) rating relating to their excessive sleepiness of 4 or more at the screening and baseline visits
    - the patient has a complaint of excessive sleepiness (at least 5 days/week on average) for at least 3 months, and the excessive sleepiness began within 12 months of the TBI
    - written informed consent is obtained
    - the patient is a man or woman of any ethnic origin 18 to 65 years of age
    - if admitted to an in-patient treatment facility, the patient was discharged at least 1 month prior to the screening visit
    - the patient does not have any medical or psychiatric disorders that could account for the excessive sleepiness
    - Women of childbearing potential (not surgically sterile or 2 years postmenopausal), must use a medically accepted method of contraception, and must continue use of one of these methods for the duration of the study (and for 30 days after participation in the study). Acceptable methods of contraception include: abstinence, barrier method with spermicide, steroidal contraceptive (oral, transdermal, mplanted, and injected) in conjunction with a barrier method, or intrauterine device (IUD).
    - the patient is in otherwise good health, as judged by the investigator, on the basis of a medical and psychiatric history, physical examination, ECG, serum chemistry, hematology, and urinalysis
    - the patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol
    - the patient has MMSE-score of more than 26 at the screening visit
    - the patient is on stable dosages of medications (allowed by the protocol) for a minimum of 3 months (SSRIs, SNRIs), 8 weeks (contraceptives), 4 weeks (other alloweded) before the screening visit and is not likely to require a change in therapy for at least 12 weeks on the basis of the investigators’ assessment.
    - the patient had no other head injury fulfilling criteria of TBI within +/- one year
    - the patient had no other head injury that were temporally related to onset or worsening of sleepiness
    - the patient has a habitual bedtime between 21:00 and 24:00
    E.4Principal exclusion criteria
    - the patient has a history of 2 or more episodes of transient loss of consciousness without clear medical explanation, or has a history of known or suspected pseudoseizure (psychogenic seizure). Patients with a history of seizure or epilepsy may be eligible following discussion with the medical monitor
    - the patient requires, or is likely to require, treatment with anticonvulsant medication during the study; or has taken anticonvulsant medication within 6 months before the screening visit
    - the patient has an unstable or uncontrolled medical (including illnesses related to the cardiovascular [including patients with a history of left ventricular hypertrophy or in patients with mitral valve prolapse who have experienced the mitral valve prolapse syndrome]), renal, or hepatic systems or surgical condition (treated or untreated) or is not a suitable candidate for treatment with armodafinil, as judged by the investigator
    - the patient has had neurosurgery involving the brain or brainstem
    - the patient has a history of schizophrenia, bipolar disorder, psychotic depression, or other psychotic episode
    - the patient has any current Axis I disorder (including depression and posttraumatic stress disorder [PTSD]) or any Axis II disorder, that in the opinion of the investigator would affect patient participation in the study or full compliance with study procedures, assessed by SCID
    - the patient has a history of, or currently meets ICSD-2 criteria for narcolepsy, OSAHS, SWSD, or any other sleep disorder associated with excessive daytime sleepiness; or the patient has a history of idiopathic hypersomnia, insomnia (requiring treatment), or sleep disorder before the development of the TBI
    - the patient has 85% or less sleep efficiency as determined from NPSG
    - the patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion
    - the patient has used any medications including OTC medicines disallowed by the protocol within 7 days or 5 half-lives (medication or its active metabolites), whichever is longer, before the baseline visit
    - the patient has a need for chronic pain medications
    - in the judgment of the investigator, the patient has a clinically significant deviation from normal in the physical examination
    - in the judgment of the investigator, the patient has any clinically significant ECG
    - the patient has a diagnosis of any type of dementia
    - the patient has a history of suicidal ideation (considered to be currently clinical significant), or is currently suicidal
    - the patient has a known hypersensitivity to Armodafinil, racemic modafinil, or any component of the study drug tablets
    - the patient has a history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies or drug reactions
    - the patient has a clinical laboratory test value(s) outside the range(s) specified below, and medical monitor has not provided written approval for study participation:
    ⎯ hemoglobin <110 g/L (11.0 g/dL) (men) or <100 g/L (10.0 g/dL) (women)
    ⎯ absolute neutrophil count (ANC) <1.5 x 109/L (<1500/mm3)
    ⎯ platelet count <100 x 109/L (<100000/mm3)
    ⎯ sodium <130 mEq/L
    ⎯ potassium >5.5 mEq/L
    ⎯ glucose >200 mg/dL (unless a repeat measurement of glucose in the fasting state is <140 mg/dL)
    ⎯ creatinine clearance <60 mL/min (calculated by the Cockcroft-Gault formula)
    ⎯ aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (GGT), or alkaline phosphatase 2 times the upper limit of normal
    ⎯ total bilirubin >25.7 μmol/L (1.5 mg/dL)
    - the subject has a history (within the past 5 years) of alcohol, narcotic, or any other drug abuse (with the exception of nicotine) as defined by DSM-IV-TR, or the subject has current evidence of substance use, without medical explanation, confirmed by results of a urine drug screen (UDS)
    - the patient has taken armodafinil, modafinil or other stimulant medication for excessive sleepiness within 1 month of the screening visit
    - the patient is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
    - the patient is known to have tested positive for HIV
    - the patient consumes an average of more than 600 mg of caffeine per day, including coffee, tea and/or other caffeine-containing beverages or food
    - the patient has used any investigational drug within 1 month before the screening visit
    - the patient is receiving workmen’s compensation or is in active litigation in regard to TBI
    - patient has an S-HAM-D score of more than 4 at Screening Visit
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measures and endpoints for this study are the MSLT and CGI-C assessed at week 12 (or last postbaseline observation).
    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 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    Last patient last visit
    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 days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    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 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 340
    F.4.2.2In the whole clinical trial 620
    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 complete 12 weeks of double-blind treatment may be eligible to participate in an open-label study if they wish to continue treatment with Armodafinil, and the investigator is in concurrence.

    Patients who withdraw from the study before the completion of the 12-week evaluation period will have visit-7 (week 12 or early termination) procedures and assessments performed at their final visit.
    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 Decision2010-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-30
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-01-04
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