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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05654870
• Other study ID #: NBI-98854-ATS3020
• Status: Terminated
• Phase: Phase 3
• Start date: January 5, 2023
• Est. completion date: November 8, 2023

Study information

• Verified date: December 2023
• Source: Neurocrine Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: November 8, 2023
• Est. primary completion date: November 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Valbenazine
Oral treatment
• Placebo
Placebo matching valbenazine

Locations

Country	Name	City	State
United States	Neurocrine Clinical Site	Atlanta	Georgia
United States	Neurocrine Clinical Site	Coral Gables	Florida
United States	Neurocrine Clinical Site	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
Neurocrine Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Positive and Negative Syndrome Scale (PANSS) Total Score from Baseline to Week 10		Baseline, Week 10
Secondary	Change in Clinical Global Impression of Severity (CGI-S) Score from Baseline to Week 10		Baseline, Week 10
Secondary	Change in Personal and Social Performance (PSP) Score from Baseline to Week 10		Baseline, Week 10

External Links

•   Study Website - Journey Study