Trial reportMovement disorders : official journal of the Movement Disorder Society2015
NBI-98854, a selective monoamine transport inhibitor for the treatment of tardive dyskinesia: A randomized, double-blind, placebo-controlled study.
Trial report in Movement disorders : official journal of the Movement Disorder Society, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 6 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
40 citing papers in PubMed, 6 syntheses or guidelines pooled it, 128 citations in OpenAlex.
- Efficacy and acceptability of pharmacological interventions for tardive dyskinesia in people with schizophrenia or mood disorders: a systematic review and network meta-analysis.Molecular psychiatry · 2025Pooled it
- Tardive Dyskinesia with Antipsychotic Medication in Children and Adolescents: A Systematic Literature Review.Drug safety · 2024Pooled it
- Treatment Recommendations for Tardive Dyskinesia.Canadian journal of psychiatry. Revue canadienne de psychiatrie · 2019Pooled it
- [Antipsychotic-induced motor symptoms in schizophrenic psychoses-Part 3 : Tardive dyskinesia].Der Nervenarzt · 2019Pooled it
- Miscellaneous treatments for antipsychotic-induced tardive dyskinesia.The Cochrane database of systematic reviews · 2018Pooled it
- Treatment of tardive dyskinesia with VMAT-2 inhibitors: a systematic review and meta-analysis of randomized controlled trials.Drug design, development and therapy · 2018Pooled it
- Pharmacokinetics, safety and tolerability of valbenazine in Korean CYP2D6 normal and intermediate metabolizers.Clinical and translational science · 2023Trial
- The effects of valbenazine on tardive dyskinesia in older and younger patients.International journal of geriatric psychiatry · 2020Trial
- Abnormal involuntary movement scale in tardive dyskinesia: Minimal clinically important difference.Movement disorders : official journal of the Movement Disorder Society · 2019Trial
- Rarely listed essential medicines in 158 national lists.Journal of pharmaceutical policy and practice · 2026Article
- VMAT2 inhibitors for the treatment of tardive dyskinesia: a narrative review.CNS spectrums · 2025Review
- Letter to the editor: Relevant errors in a systematic review and network meta-analysis evaluating the efficacy and safety of different pharmacological interventions in the treatment of tardive dyskinesia.European journal of clinical pharmacology · 2025Article
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- Exploring real-world symptom impact and improvement in well-being domains for tardive dyskinesia in VMAT2 inhibitor-treated patients via clinician survey and chart review.The mental health clinician · 2023Article
- Telehealth for Assessing and Managing Tardive Dyskinesia: Expert Insights from a Cross-Disciplinary Virtual Treatment Panel.Telemedicine journal and e-health : the official journal of the American Telemedicine Association · 2023Article
- Historical developments, hotspots, and trends in tardive dyskinesia research: a scientometric analysis of 54 years of publications.Frontiers in psychiatry · 2023Article
- Differentiating tardive dyskinesia: a video-based review of antipsychotic-induced movement disorders in clinical practice.CNS spectrums · 2022Review
- Dystonia and leveraging oral pharmacotherapy.Journal of neural transmission (Vienna, Austria : 1996) · 2021Review
- Patient perspective of tardive dyskinesia: results from a social media listening study.BMC psychiatry · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTardive 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.
methodsMale 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.
resultsTwo 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.
conclusionNBI-98854 significantly improved tardive dyskinesia and was well tolerated in patients. These results support the phase 3 clinical trials of NBI-98854 now underway.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.