Stroke Trials Registry

Lubeluzole
Prosynap®

Action
Ion channel and nitric oxide blocker.

Status
Clinical development halted after large phase III trial (Lub-Int-13) failed to show effect of study drug. Meta-analysis of several completed trials also showed no effect.

Trial(s)
= Ongoing
= Completed

LUB-INT-13 Lubeluzole in Ischemic Stroke

Lub US and Canadian Lubeluzole Ischemic Stroke Study

LUB-USA-6 Combination Therapy with Lubeluzole and t-PA in the Treatment of Acute Ischemic Stroke

Web Links and Publications

Janssen Pharmaceutical Web Site.

Lubeluzole in acute ischemic stroke treatment : A double-blind study with an 8-hour inclusion window comparing a 10-mg daily dose of lubeluzole with placebo.
Stroke 2000 Nov;31(11):2543-51

Combination Therapy Stroke Trial: rt-PA +/- Lubeluzole.
Stroke 2000 January;31(1): 278

Early clinical and radiological predictors of fatal brain swelling in ischemic stroke.
Stroke 1999 Feb;30(2):287-92.

Cardiovascular safety of lubeluzole (Prosynap(R)) in patients with ischemic stroke.
Cerebrovasc Dis. 1998 Sep-Oct;8(5):247-54.

Determination of the dose proportionality of single intravenous doses (5, 10, and 15 mg) of lubeluzole in healthy volunteers.
Clin Ther 1998 Jul-Aug;20(4):682-90

Safety and pharmacokinetics of the neuroprotective drug lubeluzole in patients with ischemic stroke.
Clin Ther 1997 Nov-Dec;19(6):1340-51

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