Author (Year) Groups Studied and Intervention Results and Findings Conclusions
[@64060] 100 patients were treated with either placebo (n=49) or valbenazine (n=51). Endpoints were a change in AIMS score from baseline and a change in CGI-TD score from baseline as rated by the blinded PI. 48.9% of participants taking the active medication had a ≥50% reduction in their AIMS score from baseline compared to 18.2% of patients in the placebo group. 67% of patients taking the active drug versus 16% of subjects in the placebo group were rated "much improved" or "very much improved" on the CGI-TD scale. No subjects taking valbenazine experienced severe TEAEs. Two patients in the placebo arm of the study experienced significant TEAEs. The overall incidence of TEAEs was higher in patients taking the active medication (49%) than those taking placebo (32.7%). No safety concerns for drug-induced akathisia, parkinsonism, depression, or suicidal ideation and behavior were noted in either arm of the study. Valbenazine is well tolerated and significantly more effective than placebo in the treatment of tardive dyskinesia.
[@64061] 234 patients were randomized in a 1:1:1 distribution to receive one of the following once daily: placebo, 40mg valbenazine, or 80mg valbenazine. Endpoints were a change in AIMS score from baseline and a change in CGI-TD score from baseline as rated by the blinded PI. 23.8% of patients taking 40mg daily and 40% of patients taking 80mg daily had a ≥50% reduction in their AIMS score from baseline compared to 8.7% of patients in the placebo group. A significant improvement in CGI-TD scores was also seen in both active medication groups when compared to placebo, but only in the per-protocol population. There was no appreciable increase in TEAEs in the treatment groups compared to the placebo, and all treatment groups remained psychiatrically stable for the duration of the trial. Valbenazine is significantly more effective than placebo in the treatment of tardive dyskinesia, and effects are dose-dependent. The medication is well-tolerated and does not exacerbate existing psychiatric conditions.
[@64074] 205 patients were either randomized 1:1 to 40mg or 80mg daily of valbenazine or continued their dose from the 6-week KINECT 3 study. Endpoints were study discontinuation due to TEAEs or 48 weeks from the beginning of the extension period. 69.2% of participants experienced TEAEs during the study period, leading to the discontinuation of 15.7% of participants. The incidence of severe TEAEs was 14.6%. BARS and SAS score changes were not clinically significant during the extension period. All psychiatric stability measurement indices remained stable throughout the extension period. Continuing measurements of AIMS and CGI-TD scores remained similar to the original 6-week trial period. Valbenazine is effective long-term for the control of TD symptoms and has a low incidence of severe TEAEs. It does not exacerbate existing psychiatric conditions, nor does it induce akathisia or parkinsonism.
[@64075] 121 of the 124 patients who completed the 48-week KINECT 3 extension period also completed the 4-week washout period and follow-up study. Endpoints were AIMS scores and CGI-TD after a 4-week drug washout period. AIMS scores at week 52 were higher than at the end of the original 6-week study period, and the percentage of responders decreased to 16.7% after washout compared to 38.5% at week six and 56% at week 48 in the 80mg valbenazine group. In the 40mg group, the responder rate was 27.8% after washout, compared to 19% after the original 6-week period and 33.3% percent at week 48. Valbenazine is effective at controlling symptoms of TD, and symptoms will recur when the medication is discontinued.