Tags

Type your tag names separated by a space and hit enter

Abnormal involuntary movement scale in tardive dyskinesia: Minimal clinically important difference.
Mov Disord. 2019 08; 34(8):1203-1209.MD

Abstract

BACKGROUND

A minimal clinically important difference has not been established for the Abnormal Involuntary Movement Scale in patients with tardive dyskinesia. Valbenazine is a vesicular monoamine transporter 2 inhibitor approved for the treatment of tardive dyskinesia in adults. Efficacy in randomized, double-blind, placebo-controlled trials was defined as the change from baseline in Abnormal Involuntary Movement Scale total score (sum of items 1-7).

OBJECTIVES

To estimate an minimal clinically important difference for the Abnormal Involuntary Movement Scale using valbenazine trial data and an anchor-based method.

METHODS

Data were pooled from three 6-week double-blind, placebo-controlled trials: KINECT (NCT01688037), KINECT 2 (NCT01733121), and KINECT 3 (NCT02274558). Valbenazine doses were pooled for analyses as follows: "low dose," which includes 40 or 50 mg/day; and "high dose," which includes 75 or 80 mg/day. Mean changes from baseline in Abnormal Involuntary Movement Scale total score were analyzed in all participants (valbenazine- and placebo-treated) with a Clinical Global Impression of Change-Tardive Dyskinesia or Patient Global Impression of Change score of 1 (very much improved) to 3 (minimally improved).

RESULTS

The least squares mean improvement from baseline to week 6 in Abnormal Involuntary Movement Scale total score was significantly greater with valbenazine (low dose: -2.4; high dose: -3.2; both, P < 0.001) versus placebo (-0.7). An minimal clinically important difference of 2 points was estimated based on least squares mean changes in Abnormal Involuntary Movement Scale total score in participants with a Clinical Global Impression of Change-Tardive Dyskinesia score ≤3 at week 6 (mean change: -2.2; median change: -2) or Patient Global Impression of Change score ≤3 at week 6 (mean change: -2.0; median change: -2).

CONCLUSIONS

Results from an anchor-based method indicate that a 2-point decrease in Abnormal Involuntary Movement Scale total score may be considered clinically important. © 2019 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.

Authors+Show Affiliations

Brody School of Medicine, East Carolina University, Greenville, North Carolina, USA.Case Western Reserve University School of Medicine, Cleveland, Ohio, USA. University Hospitals Cleveland Medical Center, Cleveland, Ohio, USA.The Zucker Hillside Hospital, Glen Oaks, New York, USA. The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA.SUNY Upstate Medical University, Syracuse, NY, USA.Neurocrine Biosciences, Inc., San Diego, California, USA.Neurocrine Biosciences, Inc., San Diego, California, USA.The Zucker Hillside Hospital, Glen Oaks, New York, USA. The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA. Charité Universitätsmedizin, Department of Child and Adolescent Psychiatry, Berlin, Germany.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

31234240

Citation

Stacy, Mark, et al. "Abnormal Involuntary Movement Scale in Tardive Dyskinesia: Minimal Clinically Important Difference." Movement Disorders : Official Journal of the Movement Disorder Society, vol. 34, no. 8, 2019, pp. 1203-1209.
Stacy M, Sajatovic M, Kane JM, et al. Abnormal involuntary movement scale in tardive dyskinesia: Minimal clinically important difference. Mov Disord. 2019;34(8):1203-1209.
Stacy, M., Sajatovic, M., Kane, J. M., Cutler, A. J., Liang, G. S., O'Brien, C. F., & Correll, C. U. (2019). Abnormal involuntary movement scale in tardive dyskinesia: Minimal clinically important difference. Movement Disorders : Official Journal of the Movement Disorder Society, 34(8), 1203-1209. https://doi.org/10.1002/mds.27769
Stacy M, et al. Abnormal Involuntary Movement Scale in Tardive Dyskinesia: Minimal Clinically Important Difference. Mov Disord. 2019;34(8):1203-1209. PubMed PMID: 31234240.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Abnormal involuntary movement scale in tardive dyskinesia: Minimal clinically important difference. AU - Stacy,Mark, AU - Sajatovic,Martha, AU - Kane,John M, AU - Cutler,Andrew J, AU - Liang,Grace S, AU - O'Brien,Christopher F, AU - Correll,Christoph U, Y1 - 2019/06/24/ PY - 2018/08/21/received PY - 2019/05/20/revised PY - 2019/05/27/accepted PY - 2019/6/25/pubmed PY - 2020/6/26/medline PY - 2019/6/25/entrez KW - AIMS KW - MCID KW - clinical trial KW - tardive dyskinesia KW - valbenazine SP - 1203 EP - 1209 JF - Movement disorders : official journal of the Movement Disorder Society JO - Mov Disord VL - 34 IS - 8 N2 - BACKGROUND: A minimal clinically important difference has not been established for the Abnormal Involuntary Movement Scale in patients with tardive dyskinesia. Valbenazine is a vesicular monoamine transporter 2 inhibitor approved for the treatment of tardive dyskinesia in adults. Efficacy in randomized, double-blind, placebo-controlled trials was defined as the change from baseline in Abnormal Involuntary Movement Scale total score (sum of items 1-7). OBJECTIVES: To estimate an minimal clinically important difference for the Abnormal Involuntary Movement Scale using valbenazine trial data and an anchor-based method. METHODS: Data were pooled from three 6-week double-blind, placebo-controlled trials: KINECT (NCT01688037), KINECT 2 (NCT01733121), and KINECT 3 (NCT02274558). Valbenazine doses were pooled for analyses as follows: "low dose," which includes 40 or 50 mg/day; and "high dose," which includes 75 or 80 mg/day. Mean changes from baseline in Abnormal Involuntary Movement Scale total score were analyzed in all participants (valbenazine- and placebo-treated) with a Clinical Global Impression of Change-Tardive Dyskinesia or Patient Global Impression of Change score of 1 (very much improved) to 3 (minimally improved). RESULTS: The least squares mean improvement from baseline to week 6 in Abnormal Involuntary Movement Scale total score was significantly greater with valbenazine (low dose: -2.4; high dose: -3.2; both, P < 0.001) versus placebo (-0.7). An minimal clinically important difference of 2 points was estimated based on least squares mean changes in Abnormal Involuntary Movement Scale total score in participants with a Clinical Global Impression of Change-Tardive Dyskinesia score ≤3 at week 6 (mean change: -2.2; median change: -2) or Patient Global Impression of Change score ≤3 at week 6 (mean change: -2.0; median change: -2). CONCLUSIONS: Results from an anchor-based method indicate that a 2-point decrease in Abnormal Involuntary Movement Scale total score may be considered clinically important. © 2019 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society. SN - 1531-8257 UR - https://www.unboundmedicine.com/medline/citation/31234240/Abnormal_involuntary_movement_scale_in_tardive_dyskinesia:_Minimal_clinically_important_difference_ L2 - https://doi.org/10.1002/mds.27769 DB - PRIME DP - Unbound Medicine ER -