Neuroprotective effect of dapsone in patients with acute ischemic stroke: a pilot study

In a previous study of brain ischemia in rats, dapsone (4,4'-diamino-diphenylsulfone) was associated with a neuroprotective effect. As dapsone is safe and relatively free of adverse reactions, we conducted a pilot clinical trial to assess the possibility of using this drug in patients with a cerebral infarction.

A double-blind, placebo-controlled, pilot clinical trial of dapsone was conducted from January 1999 to January 2000. Thirty patients with a CT or MRI documented ischemic stroke in the territory of the middle cerebral artery were included. Patients with >4 points of the National Institute of Health Stroke Scale (NIHSS) were randomly allocated to receive either a single dose of 200 mg dapsone or placebo. For follow-up, NIHSS on days 0, 2, 7 and 60, modified Rankin scale and Barthel index at day 60 were applied. Adverse reactions were also recorded. The main cut point was considered when a patient obtained a variation of 2 points for modified Rankin scale and 17 points for Barthel index.

Fifteen patients received dapsone and 15 received placebo. Twenty-nine were followed up for 60 days and one patient in the treatment group died during follow-up. Favorable scores were achieved for treated patients by all different measures; NIHSS (p=0.032), Barthel (p=0.049) and Rankin scale (RR=0.182, 95% CI: 0.04 and 0.86). Best results were obtained when treatment started within the first 8-10 hours after stroke. No adverse reactions related to medication were reported.

Dapsone appears as a useful and safe drug for the treatment of stroke patients. Results of this pilot trial are promising and support further research to define the role of dapsone as a neuroprotective drug.