BACKGROUND: Experimental studies have shown that ischaemic insults cause excess 
release of excitatory amino acid (EAA) neurotransmitters, particularly 
glutamate. Glutamate re-uptake is impaired under ischaemic conditions. In 
preclinical models of stroke, antagonists of excitatory amino acids or of 
glutamate release protect against ischaemic injury, even when administered after 
the ischaemic insult. Lubeluzole is a benzothiazole derivative that has shown 
neuroprotective properties in different experimental models inhibiting glutamate 
release, nitric oxide (NO) synthesis and blocking voltage-gated Na+ and Ca2+ ion 
channels.
OBJECTIVES: The objective of this review is to assess the effectiveness and 
safety of lubeluzole given in the acute phase of acute ischaemic stroke.
SEARCH STRATEGY: The Cochrane Stroke Group trials register was searched. 
Additional searches of Cochrane Controlled Trials Register (CENTRAL/CCTR), 
Medline, Embase, Pascal BioMed (1996-2001) and Current Contents CCSearch reg 7 
Editions (1996-2001) were made to supplement the Stroke Group general strategy. 
We contacted Janssen Research Foundation to identify further studies.
SELECTION CRITERIA: All randomised unconfounded trials comparing intravenous 
lubeluzole with placebo or open control in patients with a clinical syndrome 
definitely considered as an acute stroke in whom CT scanning showed an infarct 
or was normal.
DATA COLLECTION AND ANALYSIS: Two reviewers independently selected trials for 
inclusion, assessed trial quality and extracted the data.
MAIN RESULTS: Five trials involving a total of 3,510 patients were included. The 
quality of the trials did not vary considerably. Sensitivity/subgroups analysis 
was not completely performed because of lack of data. Lubeluzole given at the 
doses of 5, 10 and 20 mg/day for 5 days was tested against a placebo-control 
group. There was no evidence that Lubeluzole given at any dose either reduced 
the odds of death from all causes (OR=0.93, 95% CI 0.79-1.09) or reduced the 
odds of being dead or dependent at the end of follow-up (OR=1.04, 95% CI 
0.91-1.19). On the other hand, given at any dose, Lubeluzole was associated with 
a significant excess of heart-conduction disorders (Q-T prolonged > 450 msec) at 
the end of follow-up (OR=1.43, 95% CI 1.09-1.87).
REVIEWER'S CONCLUSIONS: Lubeluzole, given in the acute phase of ischaemic 
stroke, is not associated with a significant reduction of death or dependency at 
the end of scheduled follow-up period but seems to be associated with a 
significant increase of heart-conduction disorders (Q-T prolonged >450 msec).