[Skip to Navigation]
November 1996

Riluzole and Amyotrophic Lateral Sclerosis: Did Potential Market Size Bias Pharmaceutical Research?

Author Affiliations

Departments of Neurology and Community Medicine West Virginia University Health Sciences Center Morgantown, WV 26506-9180

Arch Neurol. 1996;53(11):1093-1094. doi:10.1001/archneur.1996.00550110021003

Riluzole has been reported to improve survival in patients with amyotrophic lateral sclerosis (ALS).1,2 In an initial randomized, doubleblind, placebo-controlled study, riluzole was associated with significant improvement in 12-month survival in bulbar-onset, but not limb-onset, patients with ALS.1 When both groups of patients were combined, survival was still significantly improved with riluzole.1 The ALS/Riluzole Study Group acknowledged that site of initial clinical involvement (bulbar vs limb) was an important predictor of survival in ALS.1

In the subsequent dose-ranging riluzole study,2 treatment results in bulbar-onset and limb-onset patients with ALS were not separated. After identifying such a distinct treatment disparity based on site of initial clinical involvement, the absence of these data in the subsequent report2 is puzzling. Moreover, the highly significant treatment results of the second riluzole study were dependent on an adjusted survival analysis using 10 independent prognostic factors.2 Curiously, bulbar onset

Add or change institution