NCT05110157

Journey Study: Evaluate the Efficacy, Safety, and Tolerability of Valbenazine as Adjunctive Treatment for Schizophrenia

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 442 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The 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

Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of valbenazine when administered orally once daily as adjunctive treatment in participants with schizophrenia who have had an inadequate response to antipsychotics. The study will enroll approximately 400 participants with a diagnosis of schizophrenia. The expected duration of study participation for each participant is approximately 16 weeks.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	Placebo	Oral capsules
DRUG	Valbenazine	Oral capsules

Timeline

• Start date: 2021-11-29
• Primary completion: 2025-02-04
• Completion: 2025-02-18
• First posted: 2021-11-05
• Last updated: 2026-02-10

Locations

87 sites across 4 countries: United States, Argentina, Bulgaria, Serbia

Regulatory

• FDA-regulated drug study