Background: In an attempt to better understand and define the progression of amyotrophic lateral sclerosis (ALS), we developed a classification of 5 discrete health states that reflect patients' activities of daily living. These health states were used to determine whether patients with ALS who are treated with riluzole differed from those treated with placebo.
Setting: Clinics for patients with ALS.
Design: Placebo-controlled trial of riluzole treatment in 959 patients with ALS.
Interventions: Treatment with riluzole or placebo. MAIN DEPENDENT MEASURES: A Cox model was used to assess whether, from the initial randomization to the end of an 18-month follow-up, there was a difference in the times of transition into subsequent health states between patients treated with riluzole and those treated with placebo.
Results: Our analysis showed a significant difference in the time to transit between the riluzole and the placebo groups in less severely affected cases, ie, state 2 and state A (the milder states) of ALS.
Conclusion: Patients receiving riluzole remained in the milder health states longer (P<.05).