Status:
COMPLETED
A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia
Lead Sponsor:
Neurocrine Biosciences
Conditions:
Tardive Dyskinesia
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel, fixed-dose study to evaluate the efficacy, safety, and tolerability of two doses of NBI-98854 (40 mg and 80 mg) compared to p...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT02274558
Start Date
October 1 2014
End Date
July 1 2016
Last Update
July 11 2017
Active Locations (54)
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1
Little Rock, Arkansas, United States
2
Anaheim, California, United States
3
Glendale, California, United States
4
Irvine, California, United States