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    Summary
    EudraCT Number:2007-007555-14
    Sponsor's Protocol Code Number:C10953/2032/DP/US
    National Competent Authority:Bulgarian Drug Agency
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2007-007555-14
    A.3Full title of the trial
    An 8-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to
    Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/day) as Adjunctive
    Therapy in Adults With Major Depression Associated With
    Bipolar I Disorder
    A.4.1Sponsor's protocol code numberC10953/2032/DP/US
    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 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 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 INNarmodafinil
    D.3.9.1CAS number 112111-43-0
    D.3.9.2Current sponsor codeCEP-10953
    D.3.9.3Other descriptive nameCRL 40982; R-modafinil, levo modafinil, l-modafinil, (-)-modafinil, (-)-modafinil isomer
    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 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
    Major Depression Associated With Bipolar I Disorder
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10057840
    E.1.2Term Major depression
    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 study is to determine if armodafinil treatment, at a
    dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy for adults who are
    experiencing a major depressive episode associated with Bipolar I Disorder and who are inadequately
    responsive to their current treatment for a current major depressive episode. This will be assessed by the
    change from baseline to endpoint in the total score from the 30-Item Inventory of Depressive
    Symptomatology-Clinician-Rated (IDS-C30).
    E.2.2Secondary objectives of the trial
    to evaluate
    the effectiveness of armodafinil treatment as assessed by the mean change from baseline, in the total score from MADRS, from the IDS-C30 and from the QIDS-SR 16
    • the effectiveness of armodafinil in reducing functional disability as assessed from Q-LES-Q-SF
    • the effect of armodafinil on symptoms of anxiety as assesed from HAM-A
    • the proportion of responders according to CGI-BP ratings
    • the proportion of responders as assessed by the IDS-C30
    • the proportion of patients in remission as assessed by the IDS-C30
    • the proportion of patients achieving sustained remission and response as assessed from the IDS-C30
    • the effect of armodafinil on sleep as assessed on the IDS-C30
    • the effect of armodafinil on depressed mood as assessed by the MADRS and IDS-C30
    • key features of depressive retardation as assessed in IDS-C30
    • the safety and tolerability of armodafinil
    • the impact of armodafinil on the pharmacokinetics of olanzapine and/or valproic acid
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (a) The patient has a diagnosis of Bipolar I Disorder according to the DSM-IV-TR
    criteria as determined by the SCID and is currently experiencing a major depressive
    episode.
    (b) The investigator has established, by medical record documentation or by history
    from the patient and reliable informants, that the patient has had at least 1 previous
    manic or mixed episode, which resulted in functional impairment and was treated (or
    should have been treated) with a mood stabilizer or antipsychotic medication.
    (c) The patient has had no more than 6 mood episodes in the last year.
    (d) The patient’s current major depressive episode must have started no less than
    4 weeks and no more than 12 months prior to the screening visit.
    (e) NOTE: The following inclusion criterion is no longer effective with the
    implementation of amendment 2, it is replaced by inclusion criterion (o)
    (f) The patient has been on a stable dosage of all other permitted medications (with the
    exception of medication to be used on an as-needed basis) for 4 weeks prior to the
    baseline visit
    (g) The patient has a QIDS-SR 16 score that is greater than or equal to 13 at the
    screening and baseline visits.
    (h) The patient has a CGI-BP rating (for depression) of 4 (moderately ill) or higher at the
    screening and baseline visits.
    (i) The patient has a YMRS total score of 10 or less and a score of 0 or 1 on items 1
    through 3 at the screening and baseline visits.
    (j) Written informed consent is obtained.
    (k) The patient is a man or woman 18 through 65 years of age.
    (l) The patient is in good health (except for diagnosis of Bipolar I Disorder) as judged
    by the investigator.
    (m) Women of childbearing potential (not surgically sterile or 2 years postmenopausal),
    must use a medically accepted method of contraception and must agree to continue
    use of this method for the duration of the study and for 30 days after participation in
    the study.
    (n) The patient must be willing and able to comply with study restrictions.
    (o) The patient is currently being treated with 1 or 2 of the following
    drugs: lithium, olanzapine, or valproic acid and has been taking the drug for at least
    8 weeks before screening. The patient has been on a therapeutic dose (for
    olanzapine), or maintained at a therapeutic blood level (for lithium or valproic acid),
    of these medications for at least 4 weeks prior to the baseline visit. The patient is
    prepared to remain at this dosage for the duration of the study (unless dosage
    adjustments are required to maintain therapeutic levels).
    E.4Principal exclusion criteria
    (a) NOTE: The following exclusion criterion is replaced by exclusion criterion (cc):
    (b) The patient has active psychotic symptoms.
    (c) The patient has a history of an attention-deficit/hyperactivity disorder, eating
    disorder, and/or obsessive compulsive disorder (OCD).
    (d) NOTE: The following exclusion criterion is replaced by exclusion criterion (dd):
    (e) NOTE: The following exclusion criterion is replaced by exclusion criterion (ee):
    (f) The patient has a history of stimulant-induced mania.
    (g) In the judgment of the investigator, the patient is at risk of imminent self-harm.
    (h) The patient has a history of homicidal ideation or significant aggression.
    (i) The patient has a history of any clinically significant cutaneous drug reaction.
    (j) The patient has a past or present seizure disorder, head trauma clinically significant or past neurosurgery.
    (k) The patient has any clinically significant uncontrolled medical or surgical condition
    (l) The patient has HIV.
    (m) The patient has any clinically significant deviation from normal in the physical examination.
    (n) The patient has a clinical laboratory test value(s) outside the range(s) specified.
    (o) NOTE: The following exclusion criterion is replaced by exclusion criterion (dd):
    (p) The patient has previously received modafinil or armodafinil, or the patient has a
    known sensitivity to any ingredients in the study drug tablets.
    (q) The patient has used any investigational product within 30 days of screening.
    (r) The patient is using any exclusionary medication.
    (s) Psychotherapeutic intervention has been initiated within 2 months before the
    screening visit or between the screening and baseline visits.
    (t) The patient has received cognitive behavior therapy (CBT).
    (u) The patient has received electroconvulsive therapy (ECT).
    (v) The patient has a decrease of 25% or more in the MADRS score.
    (w) The patient has a decrease of 30% or more in the QIDS-SR 16 score.
    (x) The patient has been sleeping an average of less than 6 hours per night.
    (y) The patient is unlikely to comply with the study protocol
    (z) The patient is a pregnant or lactating woman.
    (aa) The patient has any disorder that may interfere with drug absorption, distribution,
    metabolism, or excretion (including gastrointestinal surgery).
    (bb) The patient has a HAM-A score of 20 or more at the baseline visit.
    (cc) The patient has any Axis I disorder, according to DSM-IV-TR, apart from Bipolar I Disorder.
    (dd) The patient has a history of alcohol or substance dependence or abuse (with the exception of nicotine), according to DSM-IV-TR,
    (ee) The patient has any Axis II disorder, according to DSM-IV-TR.
    (ff) The patient has a positive UDS for anything other than cannabis. Patients with a positive result for cannabis may be enrolled at the discretion of the medical monitor.
    (gg) The patient has no permanent accommodations and no means of
    being contacted by the study center.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measure for this study is the IDS-C30
    assessed at week 8 or early termination.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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 months0
    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 months0
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 240
    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 Decision2008-08-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-08-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-03-02
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    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.

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