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

December 8, 2023 updated by: Neurocrine Biosciences

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Jose, California, United States, 95124
        • Neurocrine Clinical Site
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Neurocrine Clinical Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Neurocrine Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo once daily
Drug: Placebo
Placebo matching valbenazine
Experimental: Valbenazine
Valbenazine once daily
Drug: Valbenazine
Oral treatment
Other Names:
  • NBI-98854

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Positive and Negative Syndrome Scale (PANSS) Total Score from Baseline to Week 10
Time Frame: Baseline, Week 10
Baseline, Week 10

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurocrine Biosciences

Investigators

  • Study Director: Clinical Development Lead, Neurocrine Biosciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2023

Primary Completion (Actual)

November 8, 2023

Study Completion (Actual)

November 8, 2023

Study Registration Dates

First Submitted

December 8, 2022

First Submitted That Met QC Criteria

December 8, 2022

First Posted (Actual)

December 16, 2022

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 8, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBI-98854-ATS3020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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