Evidence map›Paper›PMID 31617235›Full record

Trial reportInternational journal of geriatric psychiatry2020

The effects of valbenazine on tardive dyskinesia in older and younger patients.

Martha Sajatovic, George S Alexopoulos, Joshua Burke, Khodayar Farahmand, Scott Siegert

4 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in International journal of geriatric psychiatry, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.6field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT01688037 phase2completednot on this map

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder

TypeinterventionalSponsorNeurocrine BiosciencesRan2012 to 2013Enrolled109ConditionsTardive DyskinesiaArmsNBI-98854, Placebo
NCT01733121 phase2completednot on this map

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study to Assess the Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Tardive Dyskinesia

TypeinterventionalSponsorNeurocrine BiosciencesRan2012 to 2013Enrolled102ConditionsTardive DyskinesiaArmsNBI-98854, Placebo
NCT02274558 phase3completednot on this map

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel, Fixed-Dose Study to Assess the Efficacy, Safety, and Tolerability of NBI-98854 for the Treatment of Tardive Dyskinesia

TypeinterventionalSponsorNeurocrine BiosciencesRan2014 to 2016Enrolled234ConditionsTardive DyskinesiaArmsNBI-98854, Placebo
NCT02405091 phase3completednot on this map

A Phase 3, Open-Label, Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia

TypeinterventionalSponsorNeurocrine BiosciencesRan2015 to 2017Enrolled167ConditionsTardive DyskinesiaArmsNBI-98854
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 10 citations in OpenAlex.

  1. The effects of valbenazine on tardive dyskinesia in older and younger patients.International journal of geriatric psychiatry · 2020
    Trial
  2. Trial
  3. Review
  4. Article
  5. Tardive Dyskinesia in Older Persons Taking Antipsychotics.Neuropsychiatric disease and treatment · 2021
    Review
  6. Management of Tardive Syndrome: Medications and Surgical Treatments.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2020
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Martha SajatovicDepartments of Psychiatry and of Neurology, University Hospitals Cleveland Medical Center, Cleveland, OH.ORCID 0000-0002-3073-668X
George S AlexopoulosDepartment of Psychiatry, Weill Cornell Medical College, New York, NY.ORCID 0000-0001-5677-7001
Joshua BurkeNeurocrine Biosciences, Inc., San Diego, CA.
Khodayar FarahmandNeurocrine Biosciences, Inc., San Diego, CA.
Scott SiegertNeurocrine Biosciences, Inc., San Diego, CA.
Neurocrine Biosciences (United States) · USCornell University · USUniversity Hospitals of Cleveland · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the effects of once-daily valbenazine (40 or 80 mg/d) in older and younger adults with tardive dyskinesia (TD).

methodsData were pooled from three 6-week, randomized, double-blind, placebo-controlled (DBPC) studies (KINECT [NCT01688037], KINECT 2 [NCT01733121], and KINECT 3 [NCT02274558]) and two long-term studies (KINECT 3 extension and KINECT 4 [NCT02405091]). Outcomes analyzed in older and younger participants (55 years or older and younger than 55 years, respectively) included Abnormal Involuntary Movement Scale (AIMS) response (threshold of greater than or equal to 50% improvement from baseline in total score [items 1 to 7]) and Clinical Global Impression of Change-Tardive Dyskinesia (CGI-TD) response (score 2 or less ["very much improved" or "much improved"]). Safety assessments included treatment-emergent adverse events (TEAEs).

resultsAt week 6 (end of DBPC treatment), the percentage of participants who met the AIMS response threshold was higher with valbenazine versus placebo in both subgroups: 55 years or older (80 mg/d, 39.7% [P < .001]; 40 mg/d, 28.6% [P < .01]; placebo, 9.7%); younger than 55 years (80 mg/d, 39.5% [P < .001]; 40 mg/d, 20.0% [P > .05]; placebo, 10.8%). The percentage of participants with CGI-TD response was also higher with valbenazine versus placebo: 55 years or older (80 mg/d, 41.3% [P < .01]; 40 mg/d, 30.2% [P > .05]; placebo, 19.4%); younger than 55 years (80 mg/d, 39.5% [P < .05]; 40 mg/d, 35.3% [P < .05]; placebo, 18.5%). Responses at week 48 (end of long-term treatment, combined doses) were as follows: 55 years or older (AIMS, 70.7%; CGI-TD, 82.8%); younger than 55 years (AIMS, 58.7%; CGI-TD, 72.3%). No significant differences between older and younger subgroups were found for AIMS or CGI-TD response. No new safety signals or TEAEs of clinical concern were found in older participants who received long-term treatment.

conclusionsValbenazine improved TD and was generally well tolerated in older and younger adults.

Indexed as

AdultAgedAge FactorsDouble-Blind MethodFemaleHumansMaleMiddle AgedTardive DyskinesiaTetrabenazineTreatment OutcomeValineTetrabenazinevalbenazineValineageclinical trialefficacyolder adultssafetytardive dyskinesiatolerabilityvalbenazine

Identifiers

PMID31617235
PMCPMC6916547
OpenAlexW2981176832

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.