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    Summary
    EudraCT Number:2017-001084-20
    Sponsor's Protocol Code Number:TAK-041-2001
    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:2017-06-19
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-001084-20
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo Controlled, Two-Period Cross-Over, Proof of Activity Study to Evaluate the Effects of TAK-041 on Motivational Anhedonia as Add-On to Antipsychotics in Subjects With Stable Schizophrenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An experimental trial to investigate a new medicine (drug), TAK-041, in patients with schizophrenia
    A.4.1Sponsor's protocol code numberTAK-041-2001
    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 SponsorTakeda 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 supportTakeda Development Centre Europe Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Development Centre Europe Ltd
    B.5.2Functional name of contact pointStudy Manager
    B.5.3 Address:
    B.5.3.1Street Address61 Aldwych
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC2B 4AE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4402031168000
    B.5.5Fax number+4402031168199
    B.5.6E-mailclinicaloperations@tgrd.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 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 nameTAK-041
    D.3.4Pharmaceutical form Powder for oral suspension
    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 INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeTAK-041
    D.3.9.4EV Substance CodeSUB187348
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.07 to 5.71
    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 placeboPowder for oral suspension
    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
    Schizophrenia
    E.1.1.1Medical condition in easily understood language
    Schizophrenia
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10039628
    E.1.2Term Schizophrenia and other psychotic disorders
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To determine whether motivation/reward deficits observed in schizophrenia are attenuated by add-on TAK-041 administration to antipsychotics in subjects with stable schizophrenia

    - To determine whether cognitive impairment associated with schizophrenia is improved by add-on TAK-041 administration to antipsychotics in subjects with stable schizophrenia.
    E.2.2Secondary objectives of the trial
    To determine safety and tolerability of TAK-041 as add on therapy to antipsychotics in subjects with stable schizophrenia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject understands the study procedures and agrees to participate by providing written informed consent.
    2. The subject is willing and able to comply with all study procedures and restrictions.
    3. The subject is judged to be in good health by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead ECG, and vital sign measurements performed at the Screening Visit and prior to administration of the initial dose of study drug/invasive procedure.
    4. The subject is male or female and 18 to 60 years of age, inclusive, at the Screening Visit.
    5. A female subject of childbearing potential who is sexually active with a nonsterilized male partner must agree to use 2 highly effective methods of contraception from signing of informed consent throughout the duration of the study and for 85 days after the last dose or she is postmenopausal.
    6. A male subject who is nonsterilized and sexually active with a female partner of childbearing potential must agree to use adequate contraception from signing of informed consent throughout the duration of the study and for 145 days after last dose. The female partner of a male subject should also be advised to use a highly effective/effective method of contraception.
    7. The subject is on a stable dose of an antipsychotic for at least 2 months as documented by medical history and assessed by site staff (other than those excluded in Table 7a of the protocol).
    8. The subject meets schizophrenia criteria as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) by the Mini International Neuropsychiatric Interview (MINI).
    9. The subject has PANSS total score ≤90 and PANSS negative symptom factor score (NSFS; Sum of PANSS N1, N2, N3, N4, N6, G7 and G16) ≥ 15 at screening and baseline (Day -1).
    10. The subject has stable screening and baseline (Day -1) PANSS and NSFS total scores (<20% change).
    E.4Principal exclusion criteria
    1. Has participated in another investigational trial within 4 weeks prior to the pretrial/screening visit. The 4-week window will be derived from the date of the last trial procedure and/or AE related to the trial procedure in the previous trial to the pretrial/Screening Visit of the current trial.
    2. Is an employee or immediate family member (eg, spouse, parent, child, sibling) of the Clinical Site or the Sponsor.
    3. Has a history of cancer (malignancy).
    4. Has a history of significant multiple and/or severe allergies (eg, food, drug, latex) or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food.
    5. Has a positive alcohol and/or positive drug screen at Screening or Day -1.
    6. Has a positive pregnancy test.
    7. Is a lactating/nursing female.
    8. Is positive for hepatitis B surface antigen (HBsAg), hepatitis C (HCV) antibody, or human immunodeficiency virus (HIV) antibody/antigen (confirmatory testing is allowed; most sensitive test should take precedence).
    9. The subject has abnormal screening or baseline laboratory values (> ULN for the respective serum chemistries) of ALT, AST, TBILI, ALP, GGT, confirmed upon repeat teasting, 5’-nucleotidase (screening only) and/or abnormal urine osmolality, confirmed upon repeat testing.
    10. Had major surgery, or donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the pretrial/Screening Visit.
    11. Is unable to refrain from or anticipates the use of any medication (except those prescribed), including prescription and nonprescription drugs or herbal remedies beginning approximately 7 days prior to administration of the initial dose of trial drug, throughout the trial (including washout intervals between treatment periods), until the Final Visit. Medications that are permitted are listed in Section 7.3.
    12. Meets DSM-5 criteria for substance use disorder or history of alcohol abuse within 1 month prior to Screening Visit
    13. Has a history of claustrophobia or inability to tolerate mock scanner environment during habituation/screening session.
    14. Fulfills any of the MRI contraindications on the site standard radiography screening document.
    15. Has a history in the last year or is currently receiving treatment with clozapine.
    16. Has a current diagnosis of a significant psychiatric illness other than schizophrenia, per DSM-5 and is in an acute phase/episode.
    17. Has a risk of suicide according to the investigator’s clinical judgment (eg, per C-SSRS positive answers on questions 4 or 5 for the last 6 months or has made a suicide attempt within 6 months prior to screening visit).
    18. Is unsuitable for inclusion in the study in the opinion of the investigator or sponsor.
    E.5 End points
    E.5.1Primary end point(s)
    - Change from placebo in BOLD signal in the average of left and right ventral striatum activation in the Monetary Incentive Delay (MID) Reward Task at first testing after TAK-041 administration (Day 1).

    - Change from placebo in the BACS composite score at second testing after TAK-041 administration (Day 14).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 and Day 14
    E.5.2Secondary end point(s)
    - Percentage of subjects who experience at least 1 treatment-emergent adverse event.
    - Percentage of subjects who meet the markedly abnormal criteria for safety laboratory tests at least once postdose.
    - Percentage of subjects who meet the markedly abnormal criteria for vital sign measurements at least once postdose.
    - Percentage of subjects who meet the markedly abnormal criteria for safety ECG parameters at least once postdose.
    - Columbia-Suicide Severity Rating Scale at all time points assessed.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 No
    E.8.1.6Cross over Yes
    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.8.2.4Number of treatment arms in the trial4
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    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 months1
    E.8.9.1In the Member State concerned days
    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.1.2.1Number of subjects for this age range: 32
    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 state32
    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)
    Subjects to return to standard of care overseen by their physician.
    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 Decision2017-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-11-06
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