ABSTRACT
Background: In this multicenter, randomized, placebo-controlled trial we study whether Levodopa given in addition to usual rehabilitative therapies is associated with a patient-relevant enhancement of motor recovery after acute stroke. Methods: ESTREL (Enhancement of Stroke REhabilitation with Levodopa) is a multicenter, placebo-controlled randomized superiority trial. Patients with an acute ischemic or hemorrhagic stroke ≤7 days leading to a clinically meaningful hemiparesis in need of in-hospital rehabilitation are enrolled in stroke units and later transferred to experienced neurorehabilitation centers. Participants receive Levodopa 100mg/Carbidopa 25mg three times daily or matching placebo for 5 weeks in addition to standardized rehabilitative therapy. The primary outcome is the Fugl-Meyer- Motor Assessment score 3 months after randomization. We present the characteristics of the first 200 of 610 patients to be enrolled. Results: 13 certified stroke units and 13 neurorehabilitation centers are involved (“stroke-pathway-trial”). The first 200 participants had a median age of 73 [IQR 64-82] years and 43.5 % were female. 169 patients (84.5%) had ischemic stroke. At baseline, the median NIH-Stroke scale score was 8 [5-10]. Successful 3-month assessment was performed in 183 patients (91.5%);11 (5%) died, 5 (2.5%) withdrew from the study and 1 patient missed the clinical 3 months-visit due to the COVID-19 pandemic. Conclusions: The ESTREL study will provide evidence whether the additional use of Levodopa in the rehabilitation process of stroke patients is safe and effective. The ESTREL-study started successfully due to the good cooperation between acute stroke units and rehabilitation centers, as well as the high acceptance rate among patients.