Author Affiliations: Department of Neurology, University of Washington School of Medicine, Harborview Medical Center, Seattle.
In this issue of THE JOURNAL, the Aptiganel Hydrochloride Acute Stroke
Investigators1 present the results of yet another
failed trial of neuroprotection for acute ischemic stroke. The continued negative
results of such trials are disappointing, but studies such as this one also
raise concerns. Compared with those who received placebo, patients who received
aptiganel hydrochloride within 6 hours of stroke onset tended to experience
increased morbidity and mortality. The independent data and safety monitoring
board suspended the trial after the interim (phase 2) analyses of 300 patients
were completed, but during the time needed for those analyses, 328 more patients
were enrolled in the trial and exposed to the risks of the experimental drug.
Becker KJ, Tirschwell DL. Ensuring Patient Safety in Clinical Trials for Treatment of Acute Stroke. JAMA. 2001;286(21):2718-2719. doi:10.1001/jama.286.21.2718