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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Neurocrine Biosciences
ClinicalTrials.gov Identifier:
NCT02736955
First received: April 8, 2016
Last updated: October 10, 2016
Last verified: October 2016
  Purpose
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 Intervention Phase
Tardive Dyskinesia
Drug: Valbenazine
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Neurocrine Biosciences:

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

Secondary Outcome Measures:
  • 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 ]
  • Patient Satisfaction Questionnaire [ Time Frame: Baseline (Day 1), Weeks 12, 24, 36, 48, 60 and 72 or at early termination ]
  • Social Functioning Scale (SFS) [ Time Frame: Baseline (Day 1), Weeks 12, 24, 36, 48, 60 and 72 or at early termination ]

Estimated Enrollment: 150
Study Start Date: March 2016
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Valbenazine
Fixed dose of valbenazine administered once daily for up to 72 weeks
Drug: Valbenazine
Other Name: NBI-98854

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 8, 2016
Last Updated: October 10, 2016

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

ClinicalTrials.gov processed this record on March 24, 2017