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NBI-98854, a selective monoamine transport inhibitor for the treatment of tardive dyskinesia: A randomized, double-blind, placebo-controlled study.
- Source :
-
Movement Disorders . Oct2015, Vol. 30 Issue 12, p1681-1687. 7p. - Publication Year :
- 2015
-
Abstract
- <bold>Background: </bold>Tardive dyskinesia is a persistent movement disorder induced by chronic neuroleptic exposure. NBI-98854 is a novel, highly selective, vesicular monoamine transporter 2 inhibitor. We present results of a randomized, 6-week, double-blind, placebo-controlled, dose-titration study evaluating the safety, tolerability, and efficacy of NBI-98854 for the treatment of tardive dyskinesia.<bold>Methods: </bold>Male and female adult subjects with moderate or severe tardive dyskinesia were included. NBI-98854 or placebo was given once per day starting at 25 mg and then escalated by 25 mg to a maximum of 75 mg based on dyskinesia and tolerability assessment. The primary efficacy endpoint was the change in Abnormal Involuntary Movement Scale from baseline at week 6 scored by blinded, central video raters. The secondary endpoint was the Clinical Global Impression of Change-Tardive Dyskinesia score assessed by the blinded investigator.<bold>Results: </bold>Two hundred five potential subjects were screened, and 102 were randomized; 76% of NBI-98854 subjects and 80% of placebo subjects reached the maximum allowed dose. Abnormal Involuntary Movement Scale scores for NBI-98854 compared with placebo were significantly reduced (p = 0.0005). Active drug was also superior on the Clinical Global Impression of Change-Tardive Dyskinesia (p < 0.0001). Treatment-emergent adverse event rates were 49% in the NBI-98854 and 33% in the placebo subjects. The most common adverse events (active vs. placebo) were fatigue and headache (9.8% vs. 4.1%) and constipation and urinary tract infection (3.9% vs. 6.1%). No clinically relevant changes in safety assessments were noted.<bold>Conclusion: </bold>NBI-98854 significantly improved tardive dyskinesia and was well tolerated in patients. These results support the phase 3 clinical trials of NBI-98854 now underway. [ABSTRACT FROM AUTHOR]
- Subjects :
- *CLINICAL trials
*COMPARATIVE studies
*DOSE-effect relationship in pharmacology
*HETEROCYCLIC compounds
*LONGITUDINAL method
*RESEARCH methodology
*MEDICAL cooperation
*MOVEMENT disorders
*PSYCHOLOGICAL tests
*RESEARCH
*EVALUATION research
*VALINE
*RANDOMIZED controlled trials
*TREATMENT effectiveness
*BLIND experiment
*SEVERITY of illness index
*THERAPEUTICS
Subjects
Details
- Language :
- English
- ISSN :
- 08853185
- Volume :
- 30
- Issue :
- 12
- Database :
- Academic Search Index
- Journal :
- Movement Disorders
- Publication Type :
- Academic Journal
- Accession number :
- 110361733
- Full Text :
- https://doi.org/10.1002/mds.26330