Journey Study: Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment for Schizophrenia

• Status: Not yet recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective for this study is to evaluate the effect of adjunctive valbenazine versus placebo on symptoms of schizophrenia in subjects who have inadequate response to antipsychotic treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Neurocrine Biosciences

Criteria

Inclusion Criteria:

• Subjects must meet all of the following inclusion criteria:

1. Completed written informed consent for adult subjects or written and witnessed pediatric assent from the subject and written informed consent from the subject's legal guardian in accordance with the IRB/IEC and according to local laws and regulations.

2. At the time of signing the informed consent (or assent for pediatric subjects), subject must be ≥13 years of age.

3. Medically confirmed diagnosis of schizophrenia as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

4. The initial diagnosis of schizophrenia must be ≥1 year prior to screening.

5. Plasma levels for at least 1 of the subject's antipsychotic medications must be detectable by an available assay.

6. The subject is treated with a stable regimen antipsychotic medication.

7. Must meet all of the following criteria at screening and Day 1:

• 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 screening and Day 1

• Stable PANSS total score between screening and Day 1

8. The subject is outpatient with stable symptomatology

9. The subject must have an adult informant (eg, a family member, social worker, caseworker, residential facility staff, or nurse).

10. Female subjects of childbearing potential who have undergone menarche must agree to use contraception consistently from screening until 30 days after the last dose of study drug or final study visit, whichever is longer.

11. Male subjects must agree to use contraception consistently from screening until 30 days after last dose of study treatment.

Exclusion Criteria:

• Subjects will be excluded from the study if they meet any of the following criteria:

1. Pregnant or breastfeeding or plans to become pregnant during the study. This criterion must be reconfirmed prior to the first dose of study treatment on Day 1.

2. Known hypersensitivity to any component of the formulation of valbenazine.

3. Has history of treatment resistant schizophrenia.

4. Evidence of depression as measured by a Calgary Depression Scale for Schizophrenia (CDSS) score >8 at screening and Day 1.

5. Subjects with any suicidal behavior or suicidal ideation within 6 months before screening or on Day 1.

6. Diagnosis of moderate or severe substance use disorder within the 6 months prior to screening.

7. Have a clinically significant unstable medical condition within 60 days prior to screening in the judgement of the investigator (30 days prior to screening for minor medical conditions) or any laboratory value outside the normal range that is considered by the investigator to be clinically significant at the screening visit.

8. Prior (within 6 months of Screening) or concomitant use of any VMAT2 inhibitors.