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    Summary
    EudraCT Number:2008-001766-90
    Sponsor's Protocol Code Number:LuAA21004_311
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-05-09
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-001766-90
    A.3Full title of the trial
    A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study
    Comparing the Efficacy and Safety of a Single Dose of Lu AA21004 in Acute Treatment of Adults With Generalized Anxiety Disorder
    A.4.1Sponsor's protocol code numberLuAA21004_311
    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 SponsorTakeda Global Research & Development Centre (Europe) Ltd.
    B.1.3.4CountryUnited Kingdom
    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.3.2Product code LuAA21004
    D.3.4Pharmaceutical form Capsule*
    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.3.9.2Current sponsor codeLuAA21004
    D.3.9.3Other descriptive name1-[2-(2,4-Dimethyl-phenylsulfanyl)-phenyl]-piperazine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboCapsule*
    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
    Generalized Anxiety 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 10018075
    E.1.2Term Generalised anxiety disorder
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of 5 mg Lu AA21004 QD versus placebo after 8 weeks of treatment in subjects with GAD.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of 5 mg Lu AA21004 QD compared with placebo during the 8-week, double-blind treatment.
    • To evaluate the proportion of subjects who respond to Lu AA21004 treatment compared with placebo after 8 weeks of treatment.
    • To evaluate the proportion of subjects who are in remission after 8 weeks of treatment with Lu AA21004 compared with placebo.
    • To evaluate the effect of Lu AA21004 on global clinician-rated assessments.
    • To evaluate the effect of Lu AA21004 on patient-rated assessments of anxiety, quality of life, and disability.
    • To evaluate the effects of Lu AA21004 on health care resource utilization.
    • To evaluate the population pharmacokinetics of Lu AA21004 and its metabolites Lu AA34443 and Lu AA39835.
    • To evaluate the safety and tolerability of 5 mg Lu AA21004 QD compared with placebo during the course of treatment.

    Exploratory Objective:
    • To assess the treatment effect (Lu AA21004 or placebo) on suicidal ideation and behavior.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject eligibility is determined based on the following criteria:
    1. Subjects who suffer from a primary diagnosis of GAD according to DSM-IV-TR criteria (classification code 300.02).
    2. Subjects with a Hamilton Anxiety Scale (HAM-A) total score ≥20 at Screening and Baseline.
    3. Subjects with a HAM-A score ≥2 on both Item 1 (anxious mood) and Item 2 (tension) at Screening and Baseline.
    4. Subjects with a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≤16 at Screening and Baseline.
    5. Male or female subjects aged between 18 years or older.
    6. The subject is capable of understanding and complying with protocol requirements.
    7. Male subjects, or female subjects of childbearing potential, who are sexually active agree to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication. Women not of child bearing potential are defined as those who have been surgically sterilized (documented hysterectomy, bilateral oophorectomy, or tubal ligation) or who are postmenopausal (defined as greater than or equal to 48 years of age and at least 2 years since menses). [Acceptable methods of contraception are defined in the Contraception and Pregnancy Avoidance Procedure Section of the protocol,Section 9.1.10.]
    8. Subjects who are able to understand and sign the informed consent form prior to undergoing any study-related procedures.
    E.4Principal exclusion criteria
    Subjects who meet any of the following criteria will not qualify for entry into the study:
    1. The subject has received any investigational compound <30 days before Screening or 5 half-lives prior to Screening.
    2. The subject has received Lu AA21004 in a previous clinical study or as a therapeutic agent.
    3. The subject is a study site employee, or is an immediate family member (ie, spouse, parent, child, or sibling) of a study site employee involved in conduct of this study.
    4. The subject has 1 or more of the following:
    a) Any current psychiatric disorder other than GAD as defined in the DSM-IV-TR (as assessed by the Mini International Neuropsychiatric Interview [MINI]).
    b) Current or past history of: manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
    c) Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR. (Subject must have a negative urine drug screen prior to Baseline).
    d) Presence or history of a clinically significant neurological disorder (including epilepsy).
    e) Neurodegenerative disorder (Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, Huntington disease, etc).
    f) Any Axis II disorder that might compromise the study.
    5. The subject is required to take excluded medications or it is anticipated that the subject will require treatment with at least 1 of the disallowed concomitant medications during the study. (Please refer to Section 7.3 Excluded Medications.)
    6. If female, the subject is pregnant or lactating.
    7. The subject has a significant risk of suicide according to the investigator’s opinion or has a score ≥5 on item 10 (suicidal thoughts) of the MADRS or has made a suicide attempt in the previous 6 months.
    8. The subject has previously failed to respond to adequate treatment with selective serotonin reuptake inhibitors (SSRIs) and/or serotonin norepinephrine reuptake inhibitors (SNRIs).
    9. The subject has received electroconvulsive therapy within 6 months prior to Screening.
    10. The subject is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
    11. The subject has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance.
    12. The subject has an alanine aminotransferase, aspartate aminotransferase or bilirubin level >1.5 times the upper limits of normal (×ULN).
    13. The subject has a serum creatinine of >1.5 ×ULN.
    14. The subject has a previous history of cancer that had been in remission for less than 5 years prior to the first dose of study medication. This criterion does not include those subjects with basal cell or stage I squamous cell carcinoma of the skin.
    15. The subject has clinically significant abnormal vital signs as determined by the investigator.
    16. The subject has 1 or more laboratory values outside the normal range, based on the blood or urine samples taken at Screening, that are considered by the investigator to be clinically significant.
    17. The subject has thyroid stimulating hormone (TSH) value outside the normal range at Screening and is deemed clinically significant by the investigator.
    18. The subject has an abnormal ECG as determined by the central reader and confirmed as clinically significant by the investigator.
    19. The subject has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy.
    20. The subject, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
    21. The subject has previously participated in this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study is the least squares (LS) mean change from Baseline in the 14-item HAM-A total score after 8 weeks of treatment.

    Secondary Endpoints
    Efficacy:
    Secondary efficacy endpoints for this study are:
    • LS mean change from Baseline in HAM-A total score at each week assessed.
    • Response rates at Week 8, with response defined as a ≥50% decrease in the HAM-A total score from Baseline.
    • Remission rates at Week 8, with remission defined as a HAM-A total score ≤7.
    • LS mean change from Baseline in CGI-I, CGI-S, and Hospital Anxiety and Depression Scale (HAD) at all study visits where rated.

    Pharmacoeconomic Measures:
    The following will be evaluated:
    • Sheehan Disability Scale (SDS).
    • Medical Outcomes Study (MOS) 36-Item Short-Form Health Survey (SF-36®).
    • Health care resource utilization as assessed by the Health Economic Assessment Questionnaire (HEA).

    Pharmacokinetic Endpoints:
    Individual exposure parameters of Lu AA21004 and its metabolites Lu AA34443 and
    Lu AA39835 (eg, area under the plasma concentration-time curve from time 0 to time tau (AUC[0-tau]), average observed plasma concentration (Cavg), and maximum observed plasma concentration (Cmax)) will be estimated and their correlation with relevant pharmacodynamic parameters (effect and tolerability/safety) will be explored.

    Exploratory Endpoints
    The Columbia-Suicide Severity Rating Scale (C-SSRS) will be utilized as an exploratory
    assessment.
    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 Yes
    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 concerned4
    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 years
    E.8.9.1In the Member State concerned months15
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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) 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 170
    F.4.2.2In the whole clinical trial 300
    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 Decision2008-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-07-07
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