Trial reportJournal of clinical pharmacology2025
Population Pharmacokinetic and Exposure-Efficacy Analyses of Valbenazine in Patients with Huntington's Disease: Supporting Dose Selection for Chorea Management.
Trial report in Journal of clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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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.
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Authors and funding
6 authors.
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Abstract
Valbenazine improved chorea in individuals with Huntington's disease compared to placebo in a phase 3, placebo-controlled study (KINECT-HD). Population pharmacokinetics (PK) and exposure-response (E-R) analyses focused on understanding the PK characteristics of valbenazine and its active metabolite, [+]-α-dihydrotetrabenazine ([+]-α-HTBZ), and their correlation with clinical efficacy measured by the total maximal chorea (TMC) score. Consistent with previous analyses, a two-compartmental population PK model adequately described valbenazine and [+]-α-HTBZ plasma disposition, generating reliable individual-predicted exposure levels for sequential E-R analysis. The distributions of individual-predicted steady-state exposures of valbenazine and [+]-α-HTBZ were found to largely overlap between patients with tardive dyskinesia and those with Huntington's disease (HD) chorea. The relationship between the change from baseline in TMC score and [+]-α-HTBZ systemic exposure were effectively characterized by a nonlinear E
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