Phase 4 N=89 Randomized Triple-blind Treatment

The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine

Tardive Dyskinesia (TD)

Bottom Line

View on ClinicalTrials.gov: NCT03698331 ↗

Enrolled (actual)

Serious AEs

2.3%

Results posted

Jun 2020

Primary outcome: Primary: Participants With Withdrawal-Emergent Adverse Events — 9; 13 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Valbenazine (Drug); Placebo oral capsule (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Neurocrine Biosciences
Primary completion: Apr 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Participants With Withdrawal-Emergent Adverse Events	9; 13	—
SECONDARY Participants Who Experience Worsening of Symptoms as Measured by the Physician Withdrawal Checklist-20 (PWC-20)	9; 3	—
SECONDARY Absolute Worst Total Score as Measured by the Physician Withdrawal Checklist-20 (PWC-20)	4.6; 3.9; 3.8; 3.1; 5.6; 3.3	—
SECONDARY 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)	1.9; 0.5	—
SECONDARY Overall Improvement From Baseline of TD Symptoms as Measured by the Clinical Global Impression-Tardive Dyskinesia-Improvement (CGI-TD-I) Score	3.2; 3.4; 3.0; 3.0	—
SECONDARY Change in Severity of TD Symptoms as Measured by Change From Baseline in the Clinical Global Impression-Tardive Dyskinesia-Severity (CGI-TD-S) Scale	-0.3; -0.2; -0.3; -0.3; -0.4; -0.5	—

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.

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).
Are currently pregnant or breastfeeding.
Have HIV or hepatitis B.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03698331). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.