Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia

Neurocrine Biosciences

Status and phase

Completed

Phase 3

Conditions

Tardive Dyskinesia

Treatments

Drug: Valbenazine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02736955

NBI-98854-1506

Details and patient eligibility

About

This Phase 3b, rollover study will provide participants who completed a Phase 3 valbenazine (NBI-98854) study open-label access to valbenazine (fixed doses administered once daily) for the treatment of adults with TD until valbenazine is anticipated to be available commercially or they complete 72 weeks of treatment. This study will allow enrollment of up to 150 medically stable male and female participants with TD who previously participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.

Full description

This study was terminated after 60 weeks due to the commercial availability of valbenazine.

Enrollment

161 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.
Participants of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently throughout the study and until 30 days after the last dose of valbenazine.
If using maintenance medication(s) for schizophrenia or schizoaffective disorder, mood disorder, or other conditions, be on stable doses.
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 prior to screening.
Have a known history of substance dependence, 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 arrhythmia.
Have a cancer diagnosis within 3 years prior to screening (some exceptions allowed).
Have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than valbenazine) 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.
Are currently pregnant or breastfeeding.