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    Summary
    EudraCT Number:2018-001619-65
    Sponsor's Protocol Code Number:TV46000-CNS-30072
    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:2018-07-23
    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 number2018-001619-65
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Risperidone Extended-Release Injectable Suspension (TV-46000) for Subcutaneous Use as Maintenance Treatment in Adult and Adolescent Patients with Schizophrenia
    Многоцентрово, рандомизирано, двойно-сляпо, плацебо-контролирано проучване за оценка на ефикасността, безопасността и поносимостта на инжекционна суспензия с удължено освобождаване на рисперидон (ТV-46000) за подкожно приложение като поддържащо лечение при възрастни пациенти и юноши с шизофрения
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Test if Risperidone Extended-Release Injectable Suspension (TV-46000) for Subcutaneous Use is Effective for Maintenance Treatment of Schizophrenia in Adults and Adolescents
    A.3.2Name or abbreviated title of the trial where available
    RISE (study) - Risperidone Subcutaneous Extended-Release (study)
    A.4.1Sponsor's protocol code numberTV46000-CNS-30072
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03503318
    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 SponsorTeva Branded Pharmaceutical Products R&D, 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 supportTeva Branded Pharmaceutical Products R&D, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationICON Clinical Research LLC
    B.5.2Functional name of contact pointLisa Siquel
    B.5.3 Address:
    B.5.3.1Street Address2100 Pennbrook Parkway
    B.5.3.2Town/ cityNorth Wales, PA
    B.5.3.3Post code19454
    B.5.3.4CountryUnited States
    B.5.4Telephone number+12156166961
    B.5.6E-mailLisa.Siquel@iconplc.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 nameRisperidone Extended-Release Injectable Suspension for subcutaneous
    D.3.2Product code TV-46000
    D.3.4Pharmaceutical form Prolonged-release suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRISPERIDONE
    D.3.9.1CAS number 106266-06-2
    D.3.9.2Current sponsor codeTV-46000
    D.3.9.4EV Substance CodeSUB10335MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRISPERIDONE
    D.3.9.1CAS number 106266-06-2
    D.3.9.2Current sponsor codeTV-46000
    D.3.9.4EV Substance CodeSUB10335MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRISPERIDONE
    D.3.9.1CAS number 106266-06-2
    D.3.9.2Current sponsor codeTV-46000
    D.3.9.4EV Substance CodeSUB10335MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRISPERIDONE
    D.3.9.1CAS number 106266-06-2
    D.3.9.2Current sponsor codeTV-46000
    D.3.9.4EV Substance CodeSUB10335MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRISPERIDONE
    D.3.9.1CAS number 106266-06-2
    D.3.9.2Current sponsor codeTV-46000
    D.3.9.4EV Substance CodeSUB10335MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRISPERIDONE
    D.3.9.1CAS number 106266-06-2
    D.3.9.2Current sponsor codeTV-46000
    D.3.9.4EV Substance CodeSUB10335MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRISPERIDONE
    D.3.9.1CAS number 106266-06-2
    D.3.9.2Current sponsor codeTV-46000
    D.3.9.4EV Substance CodeSUB10335MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 placeboProlonged-release suspension for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Maintenance treatment of schizophrenia in patients currently treated with oral antipsychotics
    E.1.1.1Medical condition in easily understood language
    Maintenance treatment of schizophrenia in patients currently treated with oral antipsychotics
    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 PT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    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
    The primary objective of this study is to evaluate the efficacy of TV-46000 during maintenance treatment in adult patients with schizophrenia.
    E.2.2Secondary objectives of the trial
    - to evaluate the efficacy of TV-46000 during maintenance treatment in a
    total population (adults and adolescents) and in adolescent patients with
    schizophrenia.
    - to evaluate the specific efficacy parameters of TV-46000 in the total population beyond the measures of the primary objective
    - to evaluate the safety and tolerability of TV-46000 in the total population
    - to evaluate the pharmacokinetics of oral risperidone and TV-46000
    after administration of multiple doses in adults, adolescents, and the total population
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Screening
    a. The patient has a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) for >1 year (diagnosis must be reconfirmed by SCID-5) and has had ≥ 1 episode of relapse in the last 24 months.
    b. The patient has been responsive to an antipsychotic treatment (other than clozapine) in the past year based on investigator judgement (and discussions with family members, caregivers or healthcare professionals as applicable).
    c. The patient has provided written informed consent and is competent to do so.
    d. The patient, in the investigator's judgment, requires chronic treatment with an antipsychotic medication.
    e. The patient, in the investigator's judgment, can benefit from participation in this study.
    f. The patient is able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, sc depot injection, and discontinuation of prohibited concomitant medications; can read and understand the written word in order to complete patient-reported outcomes measures; and can be
    reliably rated on assessment scales.
    g. The patient has a PANSS total score lower than 100 at screening.
    h. The patient has a stable place of residence for the previous 3 months before screening, and changes in residence are not anticipated over the course of study participation.
    i. The patient has no significant life events (such as pending loss of housing, family status change, long travel abroad, surgery, etc) that could affect study outcomes expected throughout the period of study participation.
    j. The patient is a male or female of any ethnic origin, 18 through 65 years of age at screening.
    k. The patient has a body mass index between 18.0 and 38.0 kg/m2, inclusive at screening.
    l. The patient is in adequate health as determined by medical and psychiatric history, medical examination, electrocardiogram (ECG), serum chemistry, hematology, urinalysis, and serology.
    m. Women of childbearing potential (see Appendix E of protocol) must agree not to try to become pregnant, and, unless they have exclusively same-sex partners, must agree to use a highly effective method of contraception, and agree to continue use of this method beginning 1 month before the first administration of study drugs and for the duration
    of the study and for 120 days after the last injection of study drug.
    Highly effective methods of contraception include:
    - Combined estrogen and progestogen hormonal contraception (oral, intravaginal, transdermal) associated with inhibition of ovulation; these should be initiated at least 1 month before the first dose of IMP.
    - Progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation; these should be initiated at least 1 month before the first dose of IMP.
    - Intrauterine device and intrauterine hormone-releasing system; these need to be in place at least 2 months before screening.
    - Bilateral tubal occlusion
    - Vasectomized partner provided that he is the sole sexual partner and has received medical assessment of the surgical process
    - Sexual abstinence is only considered a highly effective method if defined as refraining from heterosexual intercourse in the defined period. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient.
    n. The patient, if male, is surgically sterile, or, if capable of producing offspring, has exclusively same-sex partners or is currently using an approved method of birth control and agrees to the continued use of this method for the duration of the study (and for 120 days after the last dose of study drug). Male patients with sex partners who are women of
    childbearing potential (see Appendix E) must use condoms even if surgically sterile. In addition, male patients may not donate sperm for the duration of the study and for 120 days after taking the study drug.
    o. The patient must be willing and able to comply with study restrictions and willing to return to the investigational center for the required visits throughout the duration of the study period, including follow-up procedures and assessments as specified in this protocol.
    Randomization:
    p. The patient has not experienced mentalor physical deterioration, which prevents participation in the study per investigator judgement.
    q. The patient has demonstrated good compliance in following protocol requirements during Stage 1.
    - If the investigator or the sponsor determines that the patient was not in compliance with the study protocol, the case will be evaluated on a case-by-case basis, and the investigator and the sponsor will determine whether the patient will be randomized in the double-blind period (Stage 2). (Please refer to protocol for further randomisation inclusion criteria).
    E.4Principal exclusion criteria
    a. The patient has a current clinically significant DSM-5 diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders, or borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
    b. The patient is currently on clozapine or has received electroconvulsive therapy in the last 12 months.
    c. The patient has a history of epilepsy or seizures, neuroleptic malignant syndrome, clinically significant tardive dyskinesia, or other medical condition that would expose the patient to undue risk.
    d. The patient has a positive serology for human immunodeficiency virus (HIV)-1, HIV-2, hepatitis B surface antigen, and/or hepatitis C.
    e. The patient currently has or has a history of known hypersensitivity to risperidone or any of the excipients of TV-46000 or the oral formulation of risperidone used in the stabilization phase.
    f. The patient has a substance use disorder, including alcohol and benzodiazepines but excluding nicotine and caffeine.
    g. The patient has a significant risk of violent behavior based on the patient's medical history or investigator's judgement.
    h. The patient has a significant risk of committing suicide based on the patient's medical history or investigator's judgement and/or the C-SSRS (lifetime). Patients with a C-SSRS (current) positive response to suicidal ideation items 3, 4, or 5 are not eligible.
    i. The patient has previously participated in a Teva-sponsored clinical study with TV-46000.
    j. The patient has a clinically significant deviation from normal in the physical examination.
    k. The patient has clinically significant findings in biochemistry, hematology, ECG, or urinalysis results.
    - If the patient has a prolonged QTcF interval (defined as a QTcF interval of >450 msec for males and >470 msec for females) at screening and baseline, calculated as the mean of the triplicate ECG measurements,
    eligibility will be decided on a case-by-case basis following discussion between the investigator and the sponsor.
    l. The patient has any clinically significant uncontrolled medical condition (treated or untreated). The investigator may discuss with the medical monitor as needed.
    m. The patient is a pregnant or lactating female.
    n. The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
    o. The patient has any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments.
    p. The patient has used an investigational drug within 3 months prior to screening or has participated in a non-drug clinical trial within 30 days prior to screening.
    q. The patient is using or consuming the medications prohibited in this protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is time to impending relapse. Relapse is
    defined as 1 or more of the following items:
    - Clinical Global Impression–Improvement (CGI-I) of ≥5 (greater than or
    equal to minimally worse, ie, minimally
    worse, much worse or very much worse), AND
    - an increase of any of the following individual Positive and Negative
    Syndrome Scale (PANSS) items: conceptual disorganization,
    hallucinatory behavior, suspiciousness, and unusual thought content, to
    a score of >4 with an absolute increase of ≥2 on that specific item since
    randomization, OR
    - an increase in any of the following 4 individual PANSS items:
    conceptual disorganization, hallucinatory behavior, suspiciousness, and
    unusual thought content, to a score of >4 and an absolute increase of ≥4
    on the combined score of these 4 PANSS items (conceptual
    disorganization, hallucinatory behavior, suspiciousness, and unusual
    thought content) since randomization
    - hospitalization due to worsening of psychotic symptoms (including
    partial hospitalization programs), excluding hospitalization for
    psychosocial reasons
    - Clinical Global Impression-Severity of Suicidality (CGI-SS) of 4
    (severely suicidal) or 5 (attempted suicide) on Part 1 and/or 6 (much
    worse) or 7 (very much worse) on Part 2
    - violent behavior resulting in clinically significant self-injury, injury to
    another person, or property damage
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endpoint is time to relapse
    E.5.2Secondary end point(s)
    - time to impending relapse (as defined under the primary objective) in the total population (adults and adolescents)
    - impending relapse rate at week 24
    - percentage of patients who maintain stability at endpoint (Section 9.5.2.3 of study protocol)
    - percentage of patients achieving remission at endpoint (Section 9.5.2.4 of study protocol)
    - observed rate of impending relapse at endpoint
    - Drug Attitudes Inventory 10-item version (adult patients only)
    - Schizophrenia Quality of Life Scale (SQLS) (adult patients only)
    - time to impending relapse in adolescent patients with schizophrenia
    The safety variables include adverse events, extrapyramidal symptoms
    (EPS), risk of suicide events, depression symptoms, injection pain and
    other injection site reactions (local tolerability), vital signs, laboratory
    tests, physical examination, electrocardiogram (ECG) measurements,
    body weight, rescue medication use, time to all-cause discontinuation,
    all-cause discontinuation rates and discontinuation rates due to adverse
    events (tolerability), and the following rating scales:
    - Abnormal Involuntary Movement Scale (AIMS)
    - Simpson-Angus Scale
    - Barnes Akathisia Rating Scale
    - Columbia Suicide Severity Rating Scale (C-SSRS)
    - Calgary Depression Scale for Schizophrenia (CDSS)
    - CGI-SS
    - The pharmacokinetic endpoints are the plasma concentrations of
    risperidone, 9-OH-risperidone, and total active moiety (sum of
    risperidone and 9-OH-risperidone).
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 24 and time to relapse
    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 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.8.2.4Number of treatment arms in the trial3
    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 No
    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
    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
    End of study is defined as the date when the last patient in Stage 2 has completed all efficacy and safety assessments at the final visit per protocol.
    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 months27
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months30
    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: 695
    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 state135
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 135
    F.4.2.2In the whole clinical trial 695
    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)
    In case the patient is withdrawn from this study, no further treatment is planned by the sponsor after the patient completes their participation in this study. Patients will be advised to return to their primary physician for additional treatment. Patients may be treated in the meantime per investigator judgment and instruction as applicable.
    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 Decision2018-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-03
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