Phase 3
Completed N=234
A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia
Source: ClinicalTrials.gov NCT02274558 ↗Enrolled (actual)
234
Serious AEs
5.7%
Results posted
Jul 2017
Primary outcomePrimary: Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6 — -0.1; -3.2; -1.9 scores on a scale — p=<0.0001
◆ Published Evidence
Highly cited
253citations · ~28 / year
Pharmacologic Characterization of Valbenazine (NBI-98854) and Its Metabolites.
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.
Linked Publications (5)
-
Pharmacologic Characterization of Valbenazine (NBI-98854) and Its Metabolites.
-
The Effects of Valbenazine in Participants with Tardive Dyskinesia: Results of the 1-Year KINECT 3 Extension Study.
-
The effects of valbenazine on tardive dyskinesia in older and younger patients.
-
Characterizing Treatment Effects of Valbenazine for Tardive Dyskinesia: Additional Results From the KINECT 3 Study.
-
Improvements Over Time with Valbenazine in Elderly Adults (≥65 Years) with Tardive Dyskinesia: Post Hoc Analyses of 2 Long-Term Studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6 |
-0.1; -3.2; -1.9 | <0.0001 sig |
| SECONDARY Clinical Global Impression of Change - TD (CGI-TD) at Week 6 |
3.2; 2.9; 2.9 | 0.0742 |
| SECONDARY Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Responder Analysis at Week 6 |
6; 15; 28 | 0.0200 sig |
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.
- Female subjects must not be pregnant.
- Have one of the following clinical diagnoses for at least 3 months prior to screening: Schizophrenia or Schizoaffective Disorder, or Mood Disorder.
- Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months prior to screening.
- Have moderate or severe TD.
- If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder, be on stable doses.
- Be in good general health.
- Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
- Have a negative drug screen for amphetamines,barbiturates, benzodiazepines, phencyclidine, cocaine, opiates, or cannabinoids
Exclusion Criteria
- Have an active, clinically significant unstable medical condition within 1 month prior to screening.
- Have a known history of substance dependence, or substance (drug) 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 tachy-arrhythmia.
- Have a cancer diagnosis within 3 years of screening (some exceptions allowed)
- Have received an investigational drug within 30 days prior to 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 tetrabenazine.
- Have had previous exposure with NBI-98854 or had previously participated in an NBI-98854 clinical study.
- Are currently pregnant or breastfeeding.
Data sourced from ClinicalTrials.gov (NCT02274558) and the linked publication. 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. Informational only — not medical advice.