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    Summary
    EudraCT Number:2011-002514-37
    Sponsor's Protocol Code Number:331-10-237
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-13
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2011-002514-37
    A.3Full title of the trial
    A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Maintenance Treatment in Adults with Schizophrenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Tolerability Study of Oral OPC-34712 as Maintenance Treatment in Adults With Schizophrenia
    A.4.1Sponsor's protocol code number331-10-237
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01397786
    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 SponsorOtsuka Pharmaceutical Development & Commercialization, 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 supportOtsuka Pharmaceutical Development & Commercialization, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOtsuka Pharmaceutical Development & Commercialization, Inc.
    B.5.2Functional name of contact pointDirector
    B.5.3 Address:
    B.5.3.1Street Address2440 Research Boulevard
    B.5.3.2Town/ cityRockville, Maryland
    B.5.3.3Post code20850
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1609249-6573
    B.5.5Fax number+1609249-0573
    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 nameBrexpiprazole
    D.3.2Product code OPC-34712
    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 INNBrexpiprazole
    D.3.9.2Current sponsor codeOPC-34712
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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.IMP: 2
    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 nameBrexpiprazole
    D.3.2Product code OPC-34712
    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 INNBrexpiprazole
    D.3.9.2Current sponsor codeOPC-34712
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.IMP: 3
    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 nameBrexpiprazole
    D.3.2Product code OPC-34712
    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 INNBrexpiprazole
    D.3.9.2Current sponsor codeOPC-34712
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.IMP: 4
    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 nameBrexpiprazole
    D.3.2Product code OPC-34712
    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 INNBrexpiprazole
    D.3.9.2Current sponsor codeOPC-34712
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    Acute Schizophrenia
    E.1.1.1Medical condition in easily understood language
    Schizophrenia is a debilitating mental illness. Hallucinations and delusions most characteristic symptoms; however, social withdrawal; lack of emotion, energy and motivation may also be present.
    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 17.1
    E.1.2Level LLT
    E.1.2Classification code 10001064
    E.1.2Term Acute schizophrenia
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the long-term safety and tolerability of oral OPC-34712 as monotherapy in adults with schizophrenia.
    This trial is to be conducted on an outpatient basis.
    E.2.2Secondary objectives of the trial
    To assess the long-term efficacy of oral OPC-34712 as monotherapy in adults with schizophrenia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects who are able to provide written informed consent (as
    required by IRB/IEC) prior to the initiation of any protocol-required
    procedures.
    2. Ability, in the opinion of the principal investigator, to understand the
    nature of the trial and follow protocol requirements, including the
    prescribed dosage regimens, tablet ingestion, and discontinuation of
    prohibited concomitant medication, and to be reliably rated on
    assessment scales.
    3. Subjects with a current diagnosis of schizophrenia, as defined by
    DSM-IV-TR criteria and confirmed by the MINI for Schizophrenia and
    Psychotic Disorders Studies, and a history of the illness for at least three
    years prior to screening
    4. Subjects who are currently being treated with oral antipsychotics
    other than clozapine and who, in the opinion of the investigator, require
    chronic treatment with antipsychotic medication and could potentially
    benefit from monotherapy treatment with oral brexpiprazole for
    schizophrenia.
    5. Subjects who have been stable on antipsychotic medication or an
    antipsychotic regimen for at least one 3-month period in the last year
    prior to screening
    6. Male and female subjects 18 to 65 years of age
    7. Subjects willing to discontinue all prohibited psychotropic medications
    to meet protocol-required washouts prior to and during the trial period.
    Inclusion Criteria for Rollover Subjects from Trial 331-10-232
    8. Subjects who, in the opinion of the investigator, could potentially
    benefit from administration of oral brexpiprazole for the treatment of
    schizophrenia and who meet one of the following criteria:
    - Completed the Double-blind Maintenance Phase (i.e., Week 52 visit) of
    Trial 331-10-232
    - Met criteria for exacerbation of psychotic symptoms/impending
    relapse during the Double-blind Maintenance Phase (Phase C) of Trial
    331-10-232 and were withdrawn from the trial
    - Was participating in Phase A, B, or C of Trial 331-10-232 at the time of
    early trial termination due to a positive result from a planned interim
    analysis
    - Was participating in Phase A, B or C of Trial 331-10-232 when the trial
    reached its conclusion
    Inclusion Criteria Assessed Prior to Entry into Phase A
    8. Adequate washout of prohibited concomitant medications, including 3
    days prior to entry into Phase A for mood stabilizers and antidepressants
    9. Subject is receiving antipsychotic(s) other than clozapine. These
    subjects must be cross-titrated to brexpiprazole monotherapy over 4
    weeks using an initial dose of 1 mg to achieve a recommended target
    starting dose in Phase B of 2 mg/day
    Inclusion Criteria Assessed Prior to Entry into Phase B
    10. Adequate washout of prohibited concomitant medications, including
    14 days prior to entry into Phase B for mood stabilizers and
    antidepressants
    11. Subject is ready to receive oral brexpiprazole as monotherapy for
    treatment of schizophrenia.
    12. Outpatient status. Subjects hospitalized at the investigator's
    discretion during conversion to oral brexpiprazole in Phase A and
    hospitalization for psychosocial reasons
    E.4Principal exclusion criteria
    1. Sexually active females of childbearing potential and male subjects
    who are not practicing two different methods of birth control with their
    partner during the trial and for 30 days
    after the last dose of trial medication or who will not remain abstinent
    during the trial and for 30 days after the last dose.
    2. Females who are breast-feeding and/or who have a positive
    pregnancy test result prior to receiving open-label brexpiprazole
    3. Subjects with a major protocol violation during the course of their
    participation in the double-blind phase 3 trial (ie, Trial 331-10-230, Trial
    331-10-231, or Trial 331-10-232).
    4. Subjects with schizophrenia who are considered resistant/refractory
    to antipsychotic treatment by history or who have a history of failure to
    respond to clozapine or response to clozapine treatment only.
    5. Subjects with a current DSM-IV-TR Axis I diagnosis other than
    schizophrenia including, but not limited to schizoaffective disorder, MDD,
    bipolar disorder, post-traumatic stress disorder, anxiety
    disorders, delirium, dementia, amnestic or other cognitive disorders.
    Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid,
    or antisocial personality disorder or mental
    retardation.
    6. Subjects experiencing acute depressive symptoms within the past 30
    days, according to the investigator's opinion, that require treatment with
    an antidepressant.
    7. Subjects with a significant risk of violent behavior
    8. Subjects with clinically significant tardive dyskinesia, as determined
    by a score of ≥ 3 on Item 8 of the AIMS at entry
    9. Subjects with a score of 5 (severe akathisia) on the BARS global
    clinical assessment of akathisia at entry
    10. Subjects who have met DSM-IV-TR criteria for substance abuse or
    dependence within the past 180 days; including alcohol and
    benzodiazepines, but excluding caffeine and nicotine.
    11. Subjects with hypothyroidism or hyperthyroidism (unless condition
    has been stabilized with medications for at least the past 90 days)
    and/or an abnormal result for free T4 at
    screening/baseline.
    12. Subjects who currently have clinically significant neurological,
    hepatic, renal, metabolic, hematological, immunological, cardiovascular,
    pulmonary, or gastrointestinal disorders such as any history of
    myocardial infarction, congestive heart failure, HIV seropositive
    status/acquired immunodeficiency syndrome, or chronic hepatitis B or C.
    13. Subjects with IDDM (ie, any subjects using insulin)
    14. Subjects with known ischemic heart disease or history of myocardial
    infarction, congestive heart failure (whether controlled or uncontrolled),
    angioplasty, stenting, or coronary artery bypass
    surgery.
    15. Subjects with epilepsy or a history of seizures
    16. Subjects with uncontrolled hypertension (DBP > 95 mmHg in any
    position) or symptomatic hypotension, or orthostatic hypotension which
    is defined as a decrease of ≥ 30 mmHg in SBP
    and/or a decrease of ≥ 20 mmHg in DBP after at least 3 minutes
    standing compared to the previous supine blood pressure, OR
    development of symptoms.
    17. Subjects who would be likely to require prohibited concomitant
    therapy during the trial.
    18. Subjects who received ECT within 60 days of the Screening/Baseline
    visit for Trial 331-10-237.
    19. Subjects who have not received the first dose of IMP in either phase A or B of trial 331-10-232 will not be permitted to enter Trial 331-10-237
    E.5 End points
    E.5.1Primary end point(s)
    •Outcome Measure - safety and tolerability of OPC-34712 to be assessed by examining the frequency and severity of adverse events.

    E.5.1.1Timepoint(s) of evaluation of this end point
    up to 52 weeks (week 26 for subjects enrolled post - Amendment 2)
    E.5.2Secondary end point(s)
    •Change in Positive and Negative Syndrome Scale Positive Subscale, Negative Subscale and Total Scores.

    Change in Clinical Global Impression -Severity of Illness scale score

    ◦Change in Personal and Social Performance scale Total Score
    ◦Mean Clinical Global Impression - Improvement scale score
    ◦Improved Response rate
    ◦Discontinuation rate for lack of efficacy


    •Complete Physical Exam, including Clinical Laboratory Tests
    E.5.2.1Timepoint(s) of evaluation of this end point
    up to 52 weeks (week 26 for subjects enrolled post - Amendment 2)
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 Yes
    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) No
    E.8.2.2Placebo No
    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 EEA13
    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
    Bulgaria
    Chile
    Colombia
    Croatia
    India
    Mexico
    Philippines
    Russian Federation
    South Africa
    Taiwan
    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
    The End of Trial Date is defined as the last Date of Contact or the Date of Final Contact Attempt from the Post-treatment Follow-up eCRF page for the last subject completing or withdrawing from the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    E.8.9.2In all countries concerned by the trial months6
    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 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: 1000
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 1000
    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 will be followed-up for safety reasons as desribed in 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 Decision2012-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-25
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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