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    Summary
    EudraCT Number:2014-001891-73
    Sponsor's Protocol Code Number:SD-809-C-20
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-08-14
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2014-001891-73
    A.3Full title of the trial
    AN OPEN-LABEL, LONG-TERM SAFETY STUDY OF SD-809 (DEUTETRABENAZINE) FOR THE TREATMENT OF MODERATE TO SEVERE TARDIVE DYSKINESIA
    Otevřené dlouhodobé klinické hodnocení bezpečnosti přípravku SD-809 (Deutetrabenazin) pro léčbu středně těžkých až těžkých tardivních dyskinezí.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    AN OPEN-LABEL, LONG-TERM SAFETY STUDY OF SD-809 (DEUTETRABENAZINE) FOR THE TREATMENT OF MODERATE TO SEVERE TARDIVE DYSKINESIA
    A.4.1Sponsor's protocol code numberSD-809-C-20
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02198794
    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 SponsorAuspex Pharmaceuticals, 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 supportAuspex Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAuspex Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointGlobal Clinical Project Management
    B.5.3 Address:
    B.5.3.1Street Address145 Brandywine Parkway
    B.5.3.2Town/ cityWest Chester, PA
    B.5.3.3Post code19380
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1610 883 5998
    B.5.6E-mailleslie.marinelli@tevapharm.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 nameDeutetrabenazine
    D.3.2Product code SD-809
    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 INNDeutetrabenazine
    D.3.9.1CAS number 1392826-25-3
    D.3.9.2Current sponsor codeSD-809
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 nameDeutetrabenazine
    D.3.2Product code SD-809
    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 INNDeutetrabenazine
    D.3.9.1CAS number 1392826-25-3
    D.3.9.2Current sponsor codeSD-809
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9
    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 nameDeutetrabenazine
    D.3.2Product code SD-809
    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 INNDeutetrabenazine
    D.3.9.1CAS number 1392826-25-3
    D.3.9.2Current sponsor codeSD-809
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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 nameDeutetrabenazine
    D.3.2Product code SD-809
    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 INNDeutetrabenazine
    D.3.9.1CAS number 1392826-25-3
    D.3.9.2Current sponsor codeSD-809
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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: 5
    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 nameDeutetrabenazine
    D.3.2Product code SD-809
    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 INNDeutetrabenazine
    D.3.9.1CAS number 1392826-25-3
    D.3.9.2Current sponsor codeSD-809
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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 placeboTablet
    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
    Tardive Dyskinesia
    Tardivní dyskineze
    E.1.1.1Medical condition in easily understood language
    Involuntary movements of the tongue, lips, face trunk, and extremities.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the safety and tolerability of long-term maintenance therapy with SD-809
    • To evaluate the efficacy of long-term maintenance therapy of SD-809 to reduce the severity of abnormal involuntary movements of Tardive Dyskinesia
    • To evaluate the persistence of the therapeutic effect of SD-809.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is at least 18 years of age at Screening.
    2. Subject has successfully completed Study SD-809-C-18, SD-809-C-23, or any other controlled study of SD-809 for treatment of moderate to severe TD.
    3. Subject has a history of using a dopamine receptor antagonist for at least 3 months (or 1 month in subjects 60 years of age and older).
    4. Subject has a clinical diagnosis of TD and has had symptoms for at least 3 months prior to Screening.
    5. For subjects with underlying psychiatric illness:
    • Subject is psychiatrically stable and has had no change in psychoactive medications (including, but not limited to, neuroleptics, benzodiazepines, anticonvulsants, and mood stabilizers) for ≥ 30 days before Screening (45 days for antidepressants).
    • Subjects on long-acting (depot) medications been on stable therapy (dose, frequency) for ≥3 months before Screening.
    • Subject has a health care who is aware of the subject's participation in the trial, and does not anticipate any changes to the subject's treatment regimen (drug, dose, frequency) in the next 3 months.
    6. Subject has a history of being compliant with medications.
    7. Subject is able to swallow study drug whole.
    8. Subject has provided written, informed consent or, if subject lacks the capacity to provide informed consent, a legally authorized representative (LAR) has provided written informed consent and the subject has provided assent.
    9. In the opinion of the Investigator, the subject lives in a stable environment, and has
    adequate supervision when necessary to comply with all study procedures, attend all
    study visits, and safely participate in the trial.
    10. Subject has sufficient reading skills to comprehend the subject-completed rating scales.
    11. Female subjects of childbearing potentialb agree to use one of the following´acceptable methods of contraception from Screening through study completion if
    sexually active:
    • IUD or intrauterine system in place for at least 3 months prior to screening;
    • Subject or partner using barrier method (e.g., condom, diaphragm, or cervical cap) with spermicide from Screening through study completion;
    • Partner has a documented vasectomy >6 months prior to enrollment;
    • Stable hormonal contraception (with approved oral, transdermal, or depot regimen) for at least 3 months prior to Screening.
    E.4Principal exclusion criteria
    1. Subject has received tetrabenazine within 7 days of Baseline.
    2. Subject has received any of the following medications within 30 days of Baseline:
    • Reserpine, α-methyl-p-tyrosine (AMPT), botulinum toxin (within 3 months of
    Baseline), and medications with strong anticholinergic activity (trihexyphenidyl,
    benztropine, orphenadrine, procyclidine, and biperiden)
    • Metoclopramide, promethazine, and prochlorperazine
    • Stimulants(i.e., methylphenidate, amphetamine/dextroamphetamine,
    lisdexamphetamine, etc.), or monoamine oxidase inhibitors (MAOIs)
    • Levodopa or dopamine agonists
    3. Subject has a neurological condition other than TD that may interfere with assessing the severity of dyskinesias.
    4. Subject has a serious untreated or undertreated psychiatric illness at Baseline.
    5. Subject has active suicidal ideation at Baseline.
    6. Subject has history of any of the following within the last 6 months of Baseline:
    • Previous intent to act on suicidal ideation with a specific plan, irrespective of level of ambivalence at the time of suicidal thought
    • Previous preparatory acts to commit suicide or suicidal behavior
    • A previous actual, interrupted or aborted suicide attempt
    7. Subject has a score ≥11 on the depression subscale of the Hospital Anxiety and Depression Scale (HADS) at Baseline.
    8. Subject is developmentally disabled or has evidence of dementia.
    9. Subject has an unstable or serious medical illness at Baseline.
    10. Subject has history (within 3 months) or presence of violent behavior.
    11. Subject has a QTcF value >450 ms (males) or >460 ms (females), or
    >480 ms (with right bundle branch block [RBBB]) on 12-lead electrocardiogram (ECG) at Baseline.
    12. Subject has evidence of hepatic impairment at Screening of the parent study, as indicated by:
    • Aspartate transaminase (AST) or alanine aminotransferase (ALT) >2.5
    times the upper limit of normal (ULN).
    • Alkaline phosphatase (ALP) or total bilirubin (TBil) >2 times the ULN
    o Note: Subjects with Gilbert's Syndrome are eligible to participate if
    approved by the medical monitor.
    o Note: Subjects with abnormalities in two or more of these analytes
    (AST, ALT, ALP, TBil) must be approved by the Medical Monitor to be enrolled.
    • Prothrombin time >17 seconds (i.e. prothrombin time prolonged >4
    seconds over the ULN)
    • Positive Hepatitis B surface antigen (HBsAg).
    13. Subject has evidence of significant renal impairment at Screening of
    the parent study,, indicated by a creatinine clearance <50 mL/min, as estimated by the Cockroft-Gault formula.
    14. Subject has known allergy to tetrabenazine or to any of the
    components of SD-809.
    15. Subject has participated in an investigational drug or device trial (other than Study SD-809-C-18, Study SD-809-C-23 or any other eligible SD-809 parent study) and received study drug within 30 days (or 5 drug half-lives) of Baseline, whichever is longer.
    16. Subject is pregnant or breast-feeding at Baseline.
    17. Subject acknowledges present use of illicit drugs at Baseline.
    18. Subject has a history of alcohol or substance abuse in the previous 12 months, as defined in the DSM-V, or subject is unable to refrain from substance abuse throughout the study.
    E.5 End points
    E.5.1Primary end point(s)
    •Incidence of AEs, SAEs, severe AEs, drug related AEs, AEs leading to withdrawal during the following periods:
    o Overall
    o During titration
    o During long term treatment
    • Observed values and changes from baseline in clinical laboratory parameters (hematology, chemistry, and urinalysis)
    • Observed values and changes from baseline in vital signs
    • Observed values in ECG parameters and abnormal findings
    • Number of subjects with on-treatment QTcF values >450 ms, >480 ms, >500 ms or a change from Baseline in QTcF of >30ms or 60ms
    • Observed values and changes in UPDRS Part III (motor examination), BARS, HADS, C-SSRS, ESS, and MoCA©
    • Duration of time to achieve stable dosing of SD-809
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 4, 6, 15, 28, 41, 54, 67, 80, 93, 106, 119, 132, 145 and 158
    Weeks 0,1,13 of the new part of the study (part B)
    E.5.2Secondary end point(s)
    • The change in Abnormal Involuntary Movement Scale (AIMS) score (items 1 through 7) from Baseline of this study at each visit that this is measured as assessed by blinded central video rating.
    • The change in AIMS score (items 1 through 7) from Baseline of this study at each visit that this is measured, as assessed by the site rating.
    • The proportion of subjects who are a treatment success, based on the Clinical Global Impression of Change (CGIC) at each visit that this is measured. A treatment success is defined as Much or Very Much Improved on the CGIC from Baseline of this study.
    • Change in the modified Craniocervical Dystonia (CDQ-24) score from Baseline of this study at each visit that this is measured.
    • The proportion of subjects who have a 50% or greater reduction in AIMS score from Baseline of this study at each visit that this is measured.
    • The proportion of subjects who are a treatment success, based on the Patient Global Impression of Change (PGIC) at each visit that this is measured. A treatment success is defined as Much or Very Much Improved on the PGIC from Baseline of this study.
    • The percent change in AIMS score from Baseline of this study at each visit that this is measured.
    • Based on the change in AIMS score from Baseline of this study at each visit that this is measured, as assessed by blinded central video rating, the cumulative proportion of responders ranging from a 10% improvement from Baseline to a 90% improvement from Baseline in steps of 10 percentage points.

    The following secondary safety endpoints will be assessed in Part B:
    • Secondary safety endpoints:
    - Incidence of adverse events, serious adverse events, severe adverse events, drug-related adverse events, and adverse events leading to withdrawal
    - Observed values and changes from start of randomized withdrawal in clinical laboratory parameters (hematology, chemistry, and urinalysis)
    - Observed values and changes from start of randomized withdrawal in vital signs
    - Observed values in ECG parameters and abnormal findings
    - Number of subjects with on-treatment QTcF values >450 ms, >480 ms, >500
    ms, or a change from Baseline in QTcF of >30 ms or >60 ms
    - Observed values and changes in UPDRS Part III (motor examination), BARS,
    HADS, C-SSRS, ESS, and MoCA©

    • Primary efficacy endpoint: change from Pre-withdrawal Visit AIMS scores (items 1 through 7) as assessed by blinded central video rating to the
    Post-withdrawal Visit between subjects treated with SD-809 and subjects treated with placebo.

    : During the new part of the study (part C):
    - Incidence of adverse events, serious adverse events, severe adverse events, drug related adverse events, and adverse events leading to withdrawal from start of Part C
    - Observed values and changes in vital signs from start of Part C
    - Observed values and changes in C-SSRS from start of Part C
    - Observed values in ECG parameters and abnormal findings from start of Part C

    Number of subjects with on-treatment QTcF values >450 ms, >480 ms, >500 ms, or a change from baseline in QTcF of >30 ms or >60 ms from start of Part C
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 4, 6, 15, 28, 41, 54, 67, 80, 93, 106, 119, 132, 145 and 158

    For part B Week 0, 1 and 13
    And weeks 0,13,26,39,52 of new part of the study (part C)
    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 No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Double blind for one week in part B
    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 trial2
    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 EEA50
    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
    Czech Republic
    Germany
    Hungary
    Poland
    Slovakia
    United States
    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
    After LVLS is follow up phone contact
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months4
    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: 272
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 71
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients with Schizophrenia represented by legal representative
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 142
    F.4.2.2In the whole clinical trial 343
    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)
    Previously used the treatment of tardive dyskinesia
    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 Decision2014-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-14
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