A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine

Neurocrine Biosciences1 site in 1 country89 target enrollmentSeptember 14, 2018

ConditionsTardive Dyskinesia (TD)

InterventionsValbenazine Placebo oral capsule

DrugsValbenazine Placebo oral capsule

Overview

Phase: Phase 4
Intervention: Valbenazine
Conditions: Tardive Dyskinesia (TD)
Sponsor: Neurocrine Biosciences
Enrollment: 89
Locations: 1
Primary Endpoint: Participants With Withdrawal-Emergent Adverse Events
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase 4, randomized, double-blind, placebo-controlled study to evaluate the potential for clinical dependence and withdrawal symptoms associated with valbenazine.

Registry

clinicaltrials.gov

Start Date

September 14, 2018

End Date

April 3, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Neurocrine Biosciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment, and follow-up periods of the study.
•Have one of the following clinical diagnoses for at least 3 months before screening: Schizophrenia, Schizoaffective Disorder, or Mood Disorder
•Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months before screening.
•Be on stable doses if using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder. Subjects with bipolar disorder must be on stable doses of a mood stabilizer.
•Be in general good health.
•Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.

Exclusion Criteria

•Have an active, clinically significant unstable medical condition within 1 month before screening.
•Have a known history of substance (drug) dependence, or substance or alcohol abuse.
•Have a significant risk of suicidal or violent behavior.
•Have a known history of neuroleptic malignant syndrome.
•Have a known history of long QT syndrome or cardiac arrhythmia.
•Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
•Have ever taken valbenazine (INGREZZA or NBI-98854) or participated in a valbenazine clinical study.
•Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than NBI-98854) during the study.
•Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
•Have an allergy, hypersensitivity, or intolerance to VMAT2 inhibitors (eg, tetrabenazine, deutetrabenazine).

Arms & Interventions

Valbenazine

Valbenazine or placebo oral capsules administered once daily for 7 weeks.

Intervention: Valbenazine

Valbenazine

Valbenazine or placebo oral capsules administered once daily for 7 weeks.

Intervention: Placebo oral capsule

Placebo

Placebo oral capsules administered once daily for 7 weeks.

Intervention: Placebo oral capsule

Outcomes

Primary Outcomes

Participants With Withdrawal-Emergent Adverse Events

Time Frame: 3 weeks

A withdrawal-emergent adverse event is an adverse event that begins during the Withdrawal Period.

Secondary Outcomes

Participants Who Experience Worsening of Symptoms as Measured by the Physician Withdrawal Checklist-20 (PWC-20)(3 weeks)
Severity of Withdrawal Symptoms as Measured by the Change From Withdrawal Baseline (Week 4) to Week 7 in the Modified Cocaine Selective Severity Assessment (mCSSA)(7 weeks)
Absolute Worst Total Score as Measured by the Physician Withdrawal Checklist-20 (PWC-20)(3 weeks)
Overall Improvement From Baseline of TD Symptoms as Measured by the Clinical Global Impression-Tardive Dyskinesia-Improvement (CGI-TD-I) Score(Baseline, Week 4, Week 7)
Change in Severity of TD Symptoms as Measured by Change From Baseline in the Clinical Global Impression-Tardive Dyskinesia-Severity (CGI-TD-S) Scale(Baseline, Week 4, Week 7)