NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder
Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (12.5 and 50 mg) of NBI-98854 administered once daily (q.d.) for the treatment of tardive dyskinesia in subjects with schizophrenia or schizoaffective disorder.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Tardive Dyskinesia
Intervention
NBI-98854, NBI-98854, Placebo
Location
Woodland International Research Group, Inc
Little Rock
Arkansas
United States
72211
Status
Completed
Source
Neurocrine Biosciences
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01393600
- Information obtained from ClinicalTrials.gov on May 21, 2013
Medical and Biotech [MESH] Definitions
Dyskinesia, Drug-induced
Abnormal movements, including HYPERKINESIS; HYPOKINESIA; TREMOR; and DYSTONIA, associated with the use of certain medications or drugs. Muscles of the face, trunk, neck, and extremities are most commonly affected. Tardive dyskinesia refers to abnormal hyperkinetic movements of the muscles of the face, tongue, and neck associated with the use of neuroleptic agents (see ANTIPSYCHOTIC AGENTS). (Adams et al., Principles of Neurology, 6th ed, p1199)
Citalopram
A furancarbonitrile that is one of the SEROTONIN UPTAKE INHIBITORS used as an antidepressant. The drug is also effective in reducing ethanol uptake in alcoholics and is used in depressed patients who also suffer from tardive dyskinesia in preference to tricyclic antidepressants, which aggravate this condition.
Anti-dyskinesia Agents
Drugs used in the treatment of movement disorders. Most of these act centrally on dopaminergic or cholinergic systems. Among the most important clinically are those used for the treatment of Parkinson disease (ANTIPARKINSON AGENTS) and those for the tardive dyskinesias.
Biliary Dyskinesia
A motility disorder characterized by biliary COLIC, absence of GALLSTONES, and an abnormal GALLBLADDER ejection fraction. It is caused by gallbladder dyskinesia and/or SPHINCTER OF ODDI DYSFUNCTION.
Dyskinesias
Abnormal involuntary movements which primarily affect the extremities, trunk, or jaw that occur as a manifestation of an underlying disease process. Conditions which feature recurrent or persistent episodes of dyskinesia as a primary manifestation of disease may be referred to as dyskinesia syndromes (see MOVEMENT DISORDERS). Dyskinesias are also a relatively common manifestation of BASAL GANGLIA DISEASES.
Clinical Trials
Levetiracetam Treatment of Tardive Dyskinesia
This is a placebo-controlled study designed to learn if levetiracetam is effective for tardive dyskinesia.
Treatment of Tardive Dyskinesia With Galantamine
Tardive dyskinesia (TD), a form of movement disorder, remains a problem for some patients who received antipsychotic medications. Increasing evidence suggests that TD may result from anti...
Effects of Atypical Versus Conventional Antipsychotics on the Prevalence of Tardive Dyskinesia
This study will compare the effects of newer atypical antipsychotics with those of older conventional antipsychotics on the risk of tardive dyskinesia.
Tardive Dyskinesia and Cognitive Function
Previous researchers indicate that impaired cognitive flexibility was the primary factor distinguishing patients with from those without tardive dyskinesia (TD)1, and cognitive dysfunction...
Levetiracetam in the Treatment of Neuroleptic-induced Tardive Dyskinesia
An 8-week study to examine safety and efficacy of levetiracetam in patients with neuroleptic-induced tardive dyskinesia
PubMed Articles
Motor Symptoms of Schizophrenia: Is Tardive Dyskinesia a Symptom or Side Effect? A Modern Treatment.
Abnormal involuntary dyskinetic movements in schizophrenia patients have been documented for more than 140 years. Clinicians should distinguish between two kinds of disturbances-spontaneous dyskineti...
Previous studies investigated whether prolactin (PRL) serum level was a biomarker of antipsychotic response, schizophrenia symptomatology, and tardive dyskinesia. Most of the findings support that ant...
RATIONALE: Pharmacogenetic studies on antipsychotic-induced movement disorders (MD) in schizophrenia so far have focused mainly on tardive dyskinesia. Only a few examined the more acute antipsychotic-...
Drug Therapies for Tardive Dyskinesia: Part 2.
Tardive dyskinesia (TD) is a serious complication associated with the long-term use of dopamine receptor-blocking drugs. No drugs are approved by the U.S. Food and Drug Administration for treating TD....
This paper reviews melatonin as an overlooked factor in the developmental etiology and maintenance of schizophrenia; the neuroimmune and oxidative pathophysiology of schizophrenia; specific symptoms i...
