Protocol for BASE: a multicentre, double-blind, randomised, controlled trial of bupropion hydrochloride in acute ischaemic stroke in China
Abstract
Introduction: Stroke remains a leading cause of disability and mortality worldwide, with an urgent need for novel therapeutic strategies to improve recovery. Bupropion hydrochloride, a norepinephrine-dopamine reuptake inhibitor, may promote motor and cognitive recovery due to its unique mechanism of action. To evaluate the efficacy and safety of early adjunctive treatment with bupropion hydrochloride versus placebo on functional recovery in patients with acute ischaemic stroke.
Methods and analysis: BASE is an investigator-initiated, multicentre, randomised, double-blind, placebo-controlled trial. We plan to enrol 1054 eligible patients with acute ischaemic stroke (National Institutes of Health Stroke Scale (NIHSS) score 8-15, within 2-7 days after onset) from approximately 40 stroke centres across China. Participants will be randomly assigned (1:1) to receive either oral bupropion hydrochloride (75 mg two times per day) or matched placebo for 30 days, in addition to standard guideline-based care. The primary efficacy endpoint is the proportion of patients achieving a favourable functional outcome, defined as a modified Rankin Scale (mRS) score of 0-3 at 90 days. Key secondary endpoints include shifts in mRS scores, changes in NIHSS, Hamilton Depression Rating Scale (HAMD-17), Fugl-Meyer Motor Scale scores and quality of life (EQ-5D). Safety endpoints include mortality, vascular events and incidence of adverse events. Analyses will be performed on both the intention-to-treat…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,054 participants or records.
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