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    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2021-003714-39
    Sponsor's Protocol Code Number:NBI-98854-ATS3019
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-04-11
    Trial 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 number2021-003714-39
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment in Subjects with Schizophrenia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment in Subjects with Schizophrenia
    A.4.1Sponsor's protocol code numberNBI-98854-ATS3019
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05110157
    A.5.4Other Identifiers
    Name:EU CT no.Number:2023-508433-14-00
    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 SponsorNeurocrine Biosciences, 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 supportNeurocrine Biosciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNeurocrine Biosciences, Inc.
    B.5.2Functional name of contact pointMedical Information Call Center
    B.5.3 Address:
    B.5.3.1Street Address12780 El Camino Real
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92130
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18776413461
    B.5.6E-mailmedinfo@neurocrine.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 nameValbenazine
    D.3.2Product code NBI-98854
    D.3.4Pharmaceutical form Capsule
    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 INNValbenazine
    D.3.9.1CAS number 1639208-54-0
    D.3.9.2Current sponsor codeNBI-98854
    D.3.9.3Other descriptive nameVALBENAZINE DITOSYLATE 
    D.3.9.4EV Substance CodeSUB190738
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 nameValbenazine
    D.3.2Product code NBI-98854
    D.3.4Pharmaceutical form Capsule
    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 INNValbenazine
    D.3.9.1CAS number 1639208-54-0
    D.3.9.2Current sponsor codeNBI-98854
    D.3.9.3Other descriptive nameVALBENAZINE DITOSYLATE 
    D.3.9.4EV Substance CodeSUB190738
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Schizophrenia
    E.1.1.1Medical condition in easily understood language
    Schizophrenia
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
    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
    To evaluate the effect of adjunctive valbenazine versus placebo on symptoms of schizophrenia in subjects who have inadequate response to antipsychotic treatment.
    E.2.2Secondary objectives of the trial
    -Evaluate the effect of adjunctive valbenazine versus placebo on illness severity and subject functioning in subjects who have inadequate response to antipsychotic treatment;
    -Evaluate the safety and tolerability of valbenazine as adjunctive treatment in subjects who have inadequate response to antipsychotic treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Completed written informed consent in accordance with the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) and according to local laws and regulations.
    2. At the time of signing the informed consent subject must be ≥18 years of age.
    3. Medically confirmed diagnosis of schizophrenia as defined by the DSM-5 and confirmed by the MINI for Psychotic Disorders Version 7.0.2.
    4. The initial diagnosis of schizophrenia must be ≥1 year before the screening visit.
    5. The subject is receiving background antipsychotic therapy (other than clozapine) at a total daily dose between 3 mg and 8 mg of risperidone equivalents
    6. Plasma levels for at least 1 of the subject's antipsychotic medications must be detectable by an available assay.
    7. The subject is treated with a stable regimen antipsychotic medication.
    8. Must meet all of the following criteria at the screening visit (Visit 1) and Day 1
    (Visit 2):
    • Positive and Negative Syndrome Scale (PANSS) total score ≥70
    • PANSS score of ≥4 on at least 1 of the following:
    - P1 (delusions)
    - P3 (hallucinations)
    - P6 (suspiciousness)
    - G9 (unusual thought content)
    • Clinical Global Impression of Severity (CGI S) score ≥ 4
    • Stable background antipsychotic medication dose between the screening visit and Day 1
    • Stable PANSS total score between the screening visit and Day 1
    9. The subject is outpatient with stable symptomatology
    10. The subject's diagnosis, background antipsychotic therapy, and severity of symptoms must be confirmed by the Sponsor or designee prior to the first dose of study treatment on Day 1.
    11. The subject must have an adult informant (eg, a family member, relative, partner, social worker, caseworker, residential facility staff, or nurse).
    12. A body mass index (BMI) of 18.0 to 40.5 kg/m2 (inclusive) at the screening visit.
    13. Female subjects of childbearing potential must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at Day 1.
    14. Female subjects of childbearing potential must agree to use contraception consistently from the screening visit until 30 days after the last dose of study drug or final study visit, whichever is longer.
    15. Male subjects must agree to use contraception consistently from the screening visit until 30 days after last dose of study treatment.
    16. Willing to comply with all study procedures and restrictions; and in the opinion of the investigator, the subject is capable of understanding and complying with all study procedures and restrictions. This criterion must be reconfirmed before the first dose of study treatment on Day 1.
    E.4Principal exclusion criteria
    1. Pregnant or breastfeeding or plans to become pregnant during the study. This criterion must be reconfirmed before the first dose of study treatment on Day 1.
    2. Known hypersensitivity to any component of the formulation of valbenazine.
    3. Have comorbid Parkinsonism.
    4. Have a Barnes Akathisia Rating Scale (BARS) global clinical assessment score ≥2 at the screening visit (Visit 1). This criterion must be reconfirmed before the first dose of study treatment on Day 1.
    5. Has history of treatment resistant schizophrenia.
    6. Diagnosis of schizoaffective disorder; bipolar disorder; or a lifetime diagnosis of obsessive-compulsive disorder.
    7. Recent (within the last 6 months before the screening visit) occurrence of panic disorder, depressive episode, or other comorbid psychiatric conditions currently requiring clinical attention.
    8. Evidence of depression as measured by a Calgary Depression Scale for Schizophrenia (CDSS) score >11 at the screening visit and Day 1.
    9. Initiation or changes in nonpharmacological psychosocial therapeutic treatment (eg, day hospital treatment, cognitive-behavioral therapy) within 3 weeks before the screening visit or expected to change throughout the length of the study.
    10. Subjects with any suicidal behavior or suicidal ideation within 6 months before the screening visit or on Day 1.
    11. Diagnosis of moderate or severe substance use disorder within the 6 months before the screening visit.
    12. Positive alcohol test (value ≥0.020%) or urine drug screen for disallowed substances, including amphetamines; barbiturates; cocaine; marijuana; methadone; methamphetamine; 3,4-methylenedioxymethamphetamine (MDMA); phencyclidine; or nonprescribed benzodiazepines or opiates.
    13. Have a clinically significant unstable medical condition within 60 days before the screening visit in the judgement of the investigator or any laboratory value outside the normal range that is considered by the investigator to be clinically significant at the screening visit.
    14. Have any known history of long QT syndrome or cardiac arrhythmia.
    15. Have a triplicate average electrocardiogram (ECG) QT interval corrected for heart rate using Fridericia's formula (QTcF) of >450 msec (male subjects) or >470 msec (female subjects) or the presence of any clinically significant cardiac abnormality during the Screening Period.
    16. Have a moderate or severe hepatic impairment or chronic elevation of any of the following laboratory tests: Serum creatinine, AST, ALT, GGT, Serum total bilirubin
    17. Laboratory abnormalities of Hemoglobin, White blood cell count, Platelet count or Absolute neutrophil count at the screening visit.
    18. Have a hematologic malignancy or solid tumor diagnosed within 3 years before screening or not in remission, with the exception of localized skin cancer or carcinoma in situ of the cervix that has been excised.
    19. Have any known history of neuroleptic malignant syndrome.
    20. Are currently taking any of the prohibited medications (Section 7.1). Subjects who have received these medications in the past, must have been off them for at least 30 days before the screening visit.
    21. Has previously been enrolled and received study treatment in this study (Study NBI-98854-ATS3019) or any other valbenazine clinical trial; has used any active investigational drug in the context of a clinical study within 30 days or 5 half-lives before the screening visit, whichever is longer; has participated in 3 or more clinical studies within 12 months prior before the screening visit; or is
    currently participating in another clinical study; or has participated in a clinical study for a psychiatric condition that is exclusionary in this protocol.
    22. Prior (within 6 months of the screening visit) or concomitant use of any VMAT2 inhibitors.
    E.5 End points
    E.5.1Primary end point(s)
    Change in PANSS total score from baseline to Week 10.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline to week 10
    E.5.2Secondary end point(s)
    •Change in CGI-S score from baseline to Week 10
    •Change in Personal and Social Performance Scale (PSP) score from baseline to Week 10
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline to week 10
    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 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 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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    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
    Argentina
    Serbia
    United States
    Bulgaria
    Croatia
    Czechia
    Poland
    Romania
    Slovakia
    Spain
    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
    LVLS
    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 months23
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months23
    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: 370
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state76
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 96
    F.4.2.2In the whole clinical trial 400
    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)
    Normal treatment as discussed with their doctor.
    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 Decision2022-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-14
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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