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

Sponsor

Neurocrine Biosciences (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05654870

Collaborator

(none)

400

Enrollment

Locations

Arms

Anticipated Duration (Months)

133.3

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Valbenazine Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Valbenazine

Valbenazine once daily

Drug: Valbenazine

Oral treatment

Other Names:

NBI-98854

Placebo Comparator: Placebo

Placebo once daily

Drug: Placebo

Placebo matching valbenazine

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neurocrine Clinical Site	Miami	Florida	United States	33133
2	Neurocrine Clinical Site	Chicago	Illinois	United States	60640
3	Neurocrine Clinical Site	Buffalo	New York	United States	14215