Study to Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as an Adjunctive Treatment for Schizophrenia

NCT05654870 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: NBI-98854-ATS3020
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Schizophrenia

Keywords

schizophrenia; valbenazine; antipsychotic; VMAT2; NBI-98854; dopamine; PANSS; Adjunctive

Outcome Measures

Primary Outcomes (1)

• Change in Positive and Negative Syndrome Scale (PANSS) Total Score from Baseline to Week 10

  Baseline, Week 10

Secondary Outcomes (2)

• Change in Clinical Global Impression of Severity (CGI-S) Score from Baseline to Week 10

  Baseline, Week 10

• Change in Personal and Social Performance (PSP) Score from Baseline to Week 10

  Baseline, Week 10

Study Arms (2)

Valbenazine

EXPERIMENTAL

Valbenazine once daily

Drug: Valbenazine

Placebo

PLACEBO COMPARATOR

Placebo once daily

Drug: Placebo

Interventions

Valbenazine DRUG

Oral treatment

Also known as: NBI-98854

Valbenazine

Placebo DRUG

Placebo matching valbenazine

Placebo

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Medically confirmed diagnosis of schizophrenia
• Participant is receiving a stable regimen of background antipsychotic medication
• Plasma levels for at least 1 of the participant's antipsychotic medications must be detectable by an available assay
• Participant is an outpatient with stable symptomatology
• Participant must have an adult informant (for example, a family member, relative, partner, social worker, caseworker, residential facility staff, or nurse)

You may not qualify if:

• Has a history of treatment resistant schizophrenia
• Have a clinically significant unstable medical condition 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
• Prior (within 6 months of Screening) or concomitant use of any vesicular monoamine transporter 2 (VMAT2) inhibitor (that is, valbenazine, reserpine, tetrabenazine, deutetrabenazine); or a history of intolerance to VMAT2 inhibitors

Sponsors & Collaborators

• Neurocrine Biosciences: lead

Study Sites (3)

Neurocrine Clinical Site

San Jose, California, 95124, United States

Location

Neurocrine Clinical Site

Coral Gables, Florida, 33134, United States

Location

Neurocrine Clinical Site

Atlanta, Georgia, 30328, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

valbenazine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Clinical Development Lead

  Neurocrine Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 16, 2022
• Study Start: January 5, 2023
• Primary Completion: November 8, 2023
• Study Completion: November 8, 2023
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)