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

Neurocrine Biosciences

Status and phase: Terminated; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: Valbenazine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05654870

NBI-98854-ATS3020

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups, including a placebo group

Valbenazine

Experimental group

Description:

Valbenazine once daily

Treatment:

Drug: Valbenazine

Placebo

Placebo Comparator group

Description:

Placebo once daily

Treatment:

Drug: Placebo