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

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ClinicalTrials.gov Identifier: NCT02736955
Recruitment Status : Enrolling by invitation
First Posted : April 13, 2016
Last Update Posted : October 12, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
This Phase 3b, rollover study will provide subjects who completed a Phase 3 valbenazine (NBI-98854) study open-label access to valbenazine (fixed doses administered once daily) for the treatment of TD until valbenazine is anticipated to be available commercially or they complete 72 weeks of treatment. This study will allow enrollment of up to 75 medically stable male and female subjects with TD who previously participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.

Condition or disease Intervention/treatment Phase
Tardive Dyskinesia Drug: Valbenazine Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2016
Estimated Primary Completion Date : June 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Valbenazine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Valbenazine
Fixed dose of valbenazine administered once daily for up to 72 weeks
Drug: Valbenazine
Other Name: NBI-98854

Outcome Measures

Primary Outcome Measures :
  1. Safety and tolerability measurements (incidence and types of adverse events, physical examination, laboratory tests) [ Time Frame: Up to 72 weeks ]

Secondary Outcome Measures :
  1. Clinical Global Impression - Global Improvement of Tardive Dyskinesia - Severity (CGI-TD-Severity) [ Time Frame: Baseline (Day 1), Weeks 12, 24, 36, 48, 60 and 72 or at early termination ]
  2. Patient Satisfaction Questionnaire [ Time Frame: Baseline (Day 1), Weeks 12, 24, 36, 48, 60 and 72 or at early termination ]
  3. Social Functioning Scale (SFS) [ Time Frame: Baseline (Day 1), Weeks 12, 24, 36, 48, 60 and 72 or at early termination ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Have participated in and completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.
  • Subjects 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.
  • Have a negative urine drug screen for amphetamines, barbiturates, benzodiazepine, 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, 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736955

  Show 27 Study Locations
Sponsors and Collaborators
Neurocrine Biosciences
More Information

Responsible Party: Neurocrine Biosciences
ClinicalTrials.gov Identifier: NCT02736955     History of Changes
Other Study ID Numbers: NBI-98854-1506
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Tardive Dyskinesia
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Dyskinesia, Drug-Induced
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs