Post-hoc analysis evaluated activities of daily living (ADL) changes as assessed by PDQ-39ADL subdomain scores and correlations with changes in UPDRS-III over the 12-week period of a phase 3 study in patients with Parkinson’s Disease (PD).

In the SPAN-PD study, CVT-301 84mg significantly improved motor function in patients experiencing OFF periods at week 12, as measured by lower UPDRS-III scores, 30min postdose (P=0.009). Also 58% of patients on CVT-301 84mg achieved and maintained an ON state <60min postdose vs 36% on placebo (P=0.003). 71.4% of patients on CVT-301 84mg reported improvement in Patient Global Impression of Change (PGIC) vs 46.4% on placebo (nominal P<0.001)(Lancet Neurol.2019;18:145-154). A post-hoc analysis showed that as PDQ-39ADL subdomain scores decreased (improved), PGIC scores became more positive; a PDQ-39ADL mean change of -1.98 units was associated with PGIC outcomes of "a little improvement." Also, the lower the PDQ-39ADL, the more positive the improvement perception. Although not statistically significant, the PDQ-39ADL treatment difference (84mg vs placebo) of -2.08 surpassed the desired threshold of -1.98 units(J Parkinsons Dis.2019;9:157).  

PD patients experiencing OFF periods on oral carbidopa/levodopa regimen were randomized to placebo or CVT-301 60mg or 84mg for treatment of OFF period symptoms as needed up to 5 times/day. PDQ-39 and UPDRS-III were completed at baseline, 4, 8, 12 weeks.