A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia

Completed · Phase 3 · Has a placebo group

Conditions studied: Tardive Dyskinesia

In brief

The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.

Key facts

Study ID

NCT02274558

Run by

Neurocrine Biosciences

People needed

234

Starts

2014-10-01

Expected to finish

2016-07-01

Last updated by the study team

2017-07-11

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 good general health.
• Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
• Have a negative drug screen for amphetamines,barbiturates, benzodiazepines, 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, or 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 of screening (some exceptions allowed)
• Have received an investigational drug within 30 days prior to 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.
• Have had previous exposure with NBI-98854 or had previously participated in an NBI-98854 clinical study.
• 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 — National City, California, United States
• Study site — Norwalk, California, United States
• Study site — Oakland, California, United States
• Study site — Oceanside, 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 — Bradenton, Florida, United States
• Study site — Hialeah, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — Leesburg, Florida, United States
• Study site — Maitland, Florida, United States
• Study site — Miami, Florida, United States
• Study site — North Miami, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Oak Brook, Illinois, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Glen Burnie, Maryland, United States
• Study site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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