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    Summary
    EudraCT Number:2009-016648-38
    Sponsor's Protocol Code Number:C10953/3074
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-09-28
    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 number2009-016648-38
    A.3Full title of the trial
    A 6-Month, Open-Label, Flexible-Dosage (150 to 200 mg/day) Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to test the effect and safety of a test drug- Armodafinil with mood stabilisers in patients who suffer depression with bipolar I disorder
    A.4.1Sponsor's protocol code numberC10953/3074
    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 supportCephalon Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWorldwide Clinical Trials
    B.5.2Functional name of contact pointMargui Chia
    B.5.3 Address:
    B.5.3.1Street Address2nd Floor, 172 Tottenham Court Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1T 7NS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+440207 1216179
    B.5.5Fax number+440207 121 6160
    B.5.6E-mailmargui.chia@wwctrials.com
    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 Nuvigil
    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 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) 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
    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
    E.1.1.1Medical condition in easily understood language
    Depression and mood disorder
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    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 evaluate the safety and tolerability of long
    term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder whose most recent episode was a depressive episode.

    For full details please refer to the Protocol.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are as follows:
    • to evaluate long-term efficacy of armodafinil treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with bipolar I disorder, as assessed by the following:
    ― mean change from baseline in the total score from the 30-Item Inventory of Depressive Symptomatology–Clinician Rated (IDS-C30) to week 1 and months 1, 2, 4, and 6
    ― the mean change from baseline in the total score from the 16-Item Quick Inventory of Depressive Symptomatology Clinician Rating (QIDS-C16) (which will be derived from the IDS-C30) to week 1 and months 1, 2, 4, and 6
    • to evaluate the change from baseline in the Clinical Global Impression of Severity (CGI-S) for depression to week 1 and months 1, 2, 4, and 6
    • to evaluate the efficacy of armodafinil treatment on patient functioning as ssessed by the Global Assessment of Functioning (GAF) Scale scores at month 6

    For full details please refer to the Protocol.
    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 (NOTE: All psychiatric diagnoses are made on the basis of DSM-IV-TR criteria.):
    (a)The patient has completed 8 weeks of treatment in a Cephalon-sponsored Phase 3, double-blind study of armodafinil treatment in patients with major depression associated with bipolar I disorder.
    (b1) The patient met criteria for enrollment in the previous double-blind study and, in the opinion of the investigator, is in need of continued treatment for depression.
    (c3) During the previous double blind study, the patient must have been taking 1 (or 2) of the following protocol allowed mood stabilizers:
    • lithium
    • valproic acid
    • olanzapine
    • quetiapine
    • aripiprazole
    • lamotrigine
    • risperidone
    • ziprasidone (only if taken in combination with lithium, valproic acid, or lamotrigine)
    The following criteria must also be met:
    • The mood stabilizers must be taken in an oral formulation, with the exception of risperidone, which can be either in an oral or long acting injection formulation.
    • The patient may be taking 2 protocol allowed mood stabilizers only if
    1 of the drugs is lithium, valproic acid, or lamotrigine.
    • The patient must be judged by the investigator to be compliant with treatment with the mood stabilizer(s).
    • The patient must be willing to continue treatment with the same protocol allowed mood stabilizer(s) at dosages considered appropriate by the investigator.
    Minimum dosage requirements, if applicable, and the lengths of time they are required are provided in Protocol Table 3.
    (d)The patient has a YMRS total score of 14 or less at the enrollment visit. Patients who have a YMRS score of 12 through 14 must be discussed with the medical monitor to determine their suitability for enrollment.
    (e)Written informed consent is obtained.
    (f)The patient is a man or woman 18 through 65 years of age at the time of enrollment in the double-blind study.
    (g)The patient is in good health (except for diagnosis of bipolar I disorder) as judged by the investigator, on the basis of medical and psychiatric history, medical examination, ECG, serum chemistry, hematology, and urinalysis results.
    (h1) Women of childbearing potential (women who have not reached menopause, women who are less than 2 years postmenopausal, and women who are not surgically sterile) who are sexually active 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. Acceptable methods of contraception include barrier method with spermicide, intrauterine device (IUD), and steroidal contraceptive (oral, transdermal, implanted, and injected) in conjunction with a barrier method.
    (i)The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol.
    (j)The patient has permanent accommodations and means of being contacted by the study center.
    (k)The patient agrees not to enroll in any other clinical study while participating in this study.
    (l) The patient may temporarily reside in a clinic or hospital, or may currently be treated in an over-night medical facility at the beginning of and throughout the study, in a manner consistent with medical practices as related to the treatment of depression associated with bipolar I disorder. (NOTE: The patient must not require extended treatment due to the seriousness or worsening of symptoms; such patients are not appropriate for this trial [see exclusion criterion (p1)]).
    E.4Principal exclusion criteria
    Patients are excluded from participating in this study if 1 or more of the following criteria are met (NOTE: All psychiatric diagnoses are made on the basis of DSM-IV-TR criteria.):
    (a) The patient has any Axis I or Axis II disorder apart from bipolar I disorder that became the primary focus of treatment during the double-blind study.
    (b) The patient has psychotic symptoms or had psychosis during the double-blind study.
    (c) The patient has current active suicidal ideation, is at imminent risk of self harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present; or at enrollment has a score of 2 or more for item 18 on the IDS C30.
    (d) The patient met criteria for alcohol or substance abuse or dependence (with the exception of nicotine dependence) during the double-blind study.
    (e) The patient has any history of homicidal ideation or significant aggression or currently has homicidal or significant aggressive ideation.
    (f1) The patient has a history of any clinically significant cutaneous drug reaction, or a history of clinically significant hypersensitivity reaction, including multiple allergies
    (g) The patient has a past or present seizure disorder (except history of a single febrile seizure), or a history of clinically significant head trauma (eg, brain damage) or of brain surgery.
    (h) The patient has left ventricular hypertrophy or the patient has mitral valve prolapse and has experienced mitral valve prolapse syndrome.
    (i) The patient has human immunodeficiency virus (HIV).
    (j) The patient has any clinically significant uncontrolled medical condition, treated or untreated.
    (k) In the judgment of the investigator, the patient has any clinically significant deviation from normal in the physical examination.
    (l) The patient has evidence of current non-medical substance use on urine drug screen (UDS) or by history.
    (m) The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
    (n) The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (ADME) (including gastrointestinal surgery).
    (o) The patient is unlikely to comply with the study protocol or is unsuitable for any other reason, as judged by the investigator or medical monitor.
    (p1) The patient is an inpatient without consent or is institutionalized for reasons other than the conditions stipulated in inclusion criterion a. (Note: Also refer to inclusion criterion (l).)
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy measures and endpoints are as follows:
    • The IDS C30 assessed at week 1 and months 1, 2, 4, and 6 (or last
    postbaseline observation)
    • The QIDS-C16 (which will be derived from the IDS C30) assessed at
    week 1 and months 1, 2, 4, and 6 (or last postbaseline observation)
    • The CGI-S for depression assessed at week 1 and months 1, 2, 4, and 6 (or last postbaseline observation)
    • The GAF Scale assessed at month 6 (or last postbaseline observation)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Minimun 6 months
    E.5.2Secondary end point(s)
    The safety and tolerability of armodafinil treatment will be assessed by
    evaluating adverse events throughout the study and using the following
    additional safety and tolerability measures:
    • clinical laboratory tests (serum chemistry, hematology, and urinalysis)
    assessed at month 6 (or last postbaseline observation)
    • vital signs (blood pressure and pulse) assessed at week 1 and months
    1, 2, 4, and 6 (or last postbaseline observation)
    • ECGs assessed at month 6 (or last postbaseline observation)
    • physical examinations assessed at month 6 (or last postbaseline
    observation)
    • body weight at month 6 (or last postbaseline observation)
    • concomitant medication usage throughout the study
    • YMRS assessed at week 1 and months 1, 2, 4, and 6 (or last
    postbaseline observation)
    • C SSRS SLV assessed at week 1 and months 1, 2, 4, and 6 (or last
    postbaseline observation)
    • ISI assessed at week 1 and months 1, 2, 4, and 6 (or last postbaseline
    observation)
    • HAM A assessed at month 6 (or last postbaseline observation)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Minimun 6 months
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    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
    Argentina
    Australia
    Bulgaria
    Canada
    France
    Poland
    Serbia
    Spain
    Ukraine
    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
    As in protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months7
    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.1.1Number of subjects for this age range: 0
    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) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 900
    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 state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 900
    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)
    As per the protocol
    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 Decision2010-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-09-03
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