Phase 3 N=161 Treatment

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

Tardive Dyskinesia

Bottom Line

View on ClinicalTrials.gov: NCT02736955 ↗

Enrolled (actual)

161

Serious AEs

10.0%

Results posted

Dec 2018

Primary outcome: Primary: Number of Participants Monitored for Long-term Safety of Valbenazine — 35; 117; 8 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Valbenazine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Neurocrine Biosciences
Primary completion: Jun 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Monitored for Long-term Safety of Valbenazine	35; 117; 8	—
SECONDARY Number of Participants With Clinical Response as Assessed by the Clinical Global Impression of Tardive Dyskinesia - Severity (CGI-TD-Severity) Scale	2; 21; 0; 15; 56; 3	—
SECONDARY Number of Participants With Clinical Response as Assessed by the Patient Satisfaction Questionnaire (PSQ)	35; 116; 7; 30; 112; 6	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02736955). 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.