Schizophrenia MedDRA version: 20.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Valbenazine
Product Code: NBI-98854
Pharmaceutical Form: Capsule
INN or Proposed INN: Valbenazine
CAS Number: 1639208-54-0
Current Sponsor code: NBI-98854
Other descriptive name: VALBENA
Sponsors
Neurocrine Biosciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 370 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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 pr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of adjunctive valbenazine versus placebo on symptoms of schizophrenia in subjects who have inadequate response to antipsychotic treatment.;Secondary Objective: -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. ;Primary end point(s): Change in PANSS total score from baseline to Week 10. ;Timepoint(s) of evaluation of this end point: Baseline to week 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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;Timepoint(s) of evaluation of this end point: Baseline to week 10 | — |
Countries
Argentina, Bulgaria, Croatia, Czechia, Poland, Romania, Serbia, Slovakia, Spain, United States
Contacts
Public ContactMedical Information Call Center
Neurocrine Biosciences, Inc.
Outcome results
None listed