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

Phase 3

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: Placebo; Drug: Valbenazine

• Registration Number: NCT05654870
• Lead Sponsor: Neurocrine Biosciences

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-08
• Study First Submitted QC: 2022-12-08
• Study First Posted: 2022-12-16
• Study Start: 2023-01-05
• Primary Completion: 2023-11-08
• Study Completion: 2023-11-08
• Disposition First Posted: 2024-07-01
• Status Verified: 2024-11
• Disposition First Submitted: 2024-11-04
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• 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)

Key

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo once daily
Valbenazine	Valbenazine	Valbenazine once daily

Primary Outcome Measures

Name	Time	Method
Change in Positive and Negative Syndrome Scale (PANSS) Total Score from Baseline to Week 10	Baseline, Week 10

Secondary Outcome Measures

Name	Time	Method
Change in Personal and Social Performance (PSP) Score from Baseline to Week 10	Baseline, Week 10
Change in Clinical Global Impression of Severity (CGI-S) Score from Baseline to Week 10	Baseline, Week 10

Trial Locations

Locations (1)

Neurocrine Clinical Site; 🇺🇸 Atlanta, Georgia, United States