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Peer-reviewedCC BY 4.0CNS Spectrums

Valbenazine improves quality of life, functionality, and movement severity in patients with tardive dyskinesia: findings from the KINECT-PRO™ study

  • Christoph U. Correll1,2,3,4
  • M. Mercedes Perez-Rodriguez5
  • Joseph P. McEvoy6
  • David V. Sheehan7
  • Gustavo Alva8,9,10
  • Susan Mathias11
  • Morgan Bron12
  • Robert H. Farber12
  • Hui Zhang12
  • Eduardo Dunayevich13
  • Ashok Parameswaran12
13 affiliations
  1. 1Department of Psychiatry Research, The Zucker Hillside Hospital, Glen Oaks, NY, USA
  2. 2Department of Psychiatry and Molecular Medicine, The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA
  3. 3Department of Child and Adolescent Psychiatry, Charité - Universitätsmedizin Berlin, Berlin, Germany
  4. 4German Center for Mental Health (DZPG), Partner Site Berlin, Berlin, Germany
  5. 5Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, USA
  6. 6Augusta University Medical College of Georgia, Augusta, GA, USA
  7. 7University of South Florida Morsani College of Medicine, Tampa, FL, USA
  8. 8University of California Riverside Medical School, Riverside, CA, USA
  9. 9Hoag Hospital, Newport Beach, CA, USA
  10. 10ATP Clinical Research, Costa Mesa, CA, USA
  11. 11Health Outcomes Solutions, Palm Beach Gardens, FL, USA
  12. 12Neurocrine Biosciences Inc., San Diego, CA, USA
  13. 13Neurona Therapeutics Inc., South San Francisco, USA
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Abstract

Background/Objective: Once-daily INGREZZA® (valbenazine), a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is approved for tardive dyskinesia (TD) and Huntington’s chorea. KINECT-PRO™ (NCT05859698) is currently the only study to assess the effects of a VMAT2 inhibitor (valbenazine) on quality of life (QoL) and functionality in patients with TD using multiple validated patient-reported outcomes (PROs).

Methods: Adults with mild-to-severe TD movement severity (per Abnormal Involuntary Movement Scale [AIMS] item 8) and awareness of TD with mild-to-severe associated distress (per AIMS item 10) received open-label valbenazine (40, 60, or 80 mg) for 24 weeks. Primary endpoints included changes from baseline (CFBs) at Week 24 in 3 validated QoL/functionality PROs: Tardive Dyskinesia Impact Scale (TDIS), the only psychometrically validated PRO developed specifically for TD; Sheehan Disability Scale (SDS); and EuroQoL Group’s EQ-Visual Analogue Scale (EQ-VAS). Secondary endpoints included CFB in AIMS total score.

Results: Substantial and clinically meaningful improvements in patient-reported QoL/functionality and clinician-reported TD severity were observed throughout treatment with valbenazine in the overall study population and regardless of psychiatric diagnosis (mood disorders, psychotic disorders) or TD severity at baseline (mild, moderate/severe). At Week 24 (N = 45), mean CFBs were: TDIS (−8.0); SDS Social/Leisure (−2.3); SDS Family/Home (−1.6); EQ-VAS (+13.1); AIMS (−6.8). Previously established minimal clinically important difference (MCID) thresholds for TD were exceeded for TDIS and AIMS. Safety and tolerability were consistent with valbenazine’s known profile.

Conclusions: KINECT-PRO is the first study of its kind, and valbenazine is the only VMAT2 inhibitor to demonstrate QoL/functional improvements in patients with TD across multiple validated PROs.

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Cite

BibTeXRIS
BibTeX
@article{correll2026valbenazine,
  title = {{Valbenazine improves quality of life, functionality, and movement severity in patients with tardive dyskinesia: findings from the KINECT-PRO™ study}},
  author = {Christoph U. Correll and M. Mercedes Perez-Rodriguez and Joseph P. McEvoy and David V. Sheehan and Gustavo Alva and Susan Mathias and Morgan Bron and Robert H. Farber and Hui Zhang and Eduardo Dunayevich and Ashok Parameswaran},
  journal = {CNS Spectrums},
  year = {2026},
  month = aug,
  doi = {10.1017/s1092852926101138},
  url = {https://doi.org/10.1017/s1092852926101138},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Valbenazine improves quality of life, functionality, and movement severity in patients with tardive dyskinesia: findings from the KINECT-PRO™ study
AU  - Christoph U. Correll
AU  - M. Mercedes Perez-Rodriguez
AU  - Joseph P. McEvoy
AU  - David V. Sheehan
AU  - Gustavo Alva
AU  - Susan Mathias
AU  - Morgan Bron
AU  - Robert H. Farber
AU  - Hui Zhang
AU  - Eduardo Dunayevich
AU  - Ashok Parameswaran
PY  - 2026
DA  - 2026/08/11
JO  - CNS Spectrums
DO  - 10.1017/s1092852926101138
UR  - https://doi.org/10.1017/s1092852926101138
AB  - Background/Objective: Once-daily INGREZZA® (valbenazine), a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is approved for tardive dyskinesia (TD) and Huntington’s chorea. KINECT-PRO™ (NCT05859698) is currently the only study to assess the effects of a VMAT2 inhibitor (valbenazine) on quality of life (QoL) and functionality in patients with TD using multiple validated patient-reported outcomes (PROs).  Methods: Adults with mild-to-severe TD movement severity (per Abnormal Involuntary Movement Scale [AIMS] item 8) and awareness of TD with mild-to-severe associated distress (per AIMS item 10) received open-label valbenazine (40, 60, or 80 mg) for 24 weeks. Primary endpoints included changes from baseline (CFBs) at Week 24 in 3 validated QoL/functionality PROs: Tardive Dyskinesia Impact Scale (TDIS), the only psychometrically validated PRO developed specifically for TD; Sheehan Disability Scale (SDS); and EuroQoL Group’s EQ-Visual Analogue Scale (EQ-VAS). Secondary endpoints included CFB in AIMS total score.  Results: Substantial and clinically meaningful improvements in patient-reported QoL/functionality and clinician-reported TD severity were observed throughout treatment with valbenazine in the overall study population and regardless of psychiatric diagnosis (mood disorders, psychotic disorders) or TD severity at baseline (mild, moderate/severe). At Week 24 (N = 45), mean CFBs were: TDIS (−8.0); SDS Social/Leisure (−2.3); SDS Family/Home (−1.6); EQ-VAS (+13.1); AIMS (−6.8). Previously established minimal clinically important difference (MCID) thresholds for TD were exceeded for TDIS and AIMS. Safety and tolerability were consistent with valbenazine’s known profile.  Conclusions: KINECT-PRO is the first study of its kind, and valbenazine is the only VMAT2 inhibitor to demonstrate QoL/functional improvements in patients with TD across multiple validated PROs.
SN  - 1092-8529
SN  - 2165-6509
ER  -