Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia

Completed · Phase 3

Conditions studied: Tardive Dyskinesia

In brief

Phase 3, open-label, study to evaluate the safety and tolerability of NBI-98854 administered once daily (qd) for a total of 48 weeks of treatment. This study will enroll approximately 150 medically stable male and female subjects with clinical diagnoses of schizophrenia or schizoaffective disorder with neuroleptic-induced TD or mood disorder with neuroleptic-induced TD.

Key facts

Study ID

NCT02405091

Run by

Neurocrine Biosciences

People needed

167

Starts

2015-03-01

Expected to finish

2017-03-01

Last updated by the study team

2018-11-30

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 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.

You may not qualify if…

• 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 tachy-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 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.
• Are currently pregnant or breastfeeding.

Where it is running

• Study site — Anaheim, California, United States
• Study site — Glendale, California, United States
• Study site — Irvine, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Oakland, California, United States
• Study site — San Bernardino, California, United States
• Study site — San Diego, California, United States
• Study site — Torrance, California, United States
• Study site — Hockessin, Delaware, United States
• Study site — Bradenton, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — Miami, Florida, United States
• Study site — North Miami, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Chicago, Illinois, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Natick, Massachusetts, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — Lincoln, Nebraska, United States
• Study site — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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