Abstract Background and aims Levodopa has been proposed to enhance motor recovery after stroke by stimulating dopaminergic pathways involved in reward and motor learning. To assess potential late effects, we analyzed the prespecified 12-month long-term follow-up of the Enhancement of Stroke Rehabilitation with Levodopa (ESTREL) trial. Methods ESTREL was a randomized, double-blind, placebo-controlled trial of 610 participants receiving levodopa/carbidopa or placebo added to standardized rehabilitation therapy for 39 days. The original 3-month analysis showed no treatment effect on Fugl-Meyer Motor Assessment (FMA) total scores. The present analysis evaluated the adjusted between-group difference in FMA total scores at 12 months using a linear regression model adjusted for the baseline FMA. Secondary outcomes included the National Institutes of Health Stroke Scale (NIHSS), modified Rankin Scale (mRS), and Rivermead Mobility Index (RMI) at 12 months. Results 328 participants with complete 12-month FMA data (165 levodopa, 163 placebo) were included in the analysis. Median age was 73 years, 40% were female, attrition was comparable between treatment groups, and key baseline characteristics were balanced. At 12 months, the median FMA total score was 81 58–91 in the levodopa and 79 58–91 in the placebo group, corresponding to an estimated adjusted mean difference of 1.8 points (95% CI –2.5 to 6.0). Secondary outcomes, including NIHSS, mRS, and RMI, showed no differences between groups. Conclusions ESTREL showed that levodopa-treatment during in-hospital rehabilitation did not improve motor recovery within the first year after acute stroke. Nevertheless, motor recovery can be expected to continue for at least one year. Conflict of interest Simon Trüssel: Nothing to disclose, Josefine Kaufmann: Nothing to disclose, Christopher Tränka: Nothing to disclose, Henrik Gensicke: nothing to disclose, Stefan Engelter: Nothing to disclose, Philippe Lyrer: Nothing to disclose.
Trüssel et al. (Fri,) studied this question.