Technology Overview

The ALS-HI is a fully valid, reliable, responsive, and disease-specific instrument capable of measuring changes in patient-reported health in patients with amyotrophic lateral sclerosis in response to therapeutic intervention during clinical trials or clinical monitoring. The ALS-HI was designed and validated to fully satisfy published FDA and other regulatory guidance for use in drug labeling claims.

This disease-specific regulatory-grade outcome measure is designed to measure the patient’s experience throughout the course of their disease. Utilizing published FDA guidance for its development and validation, this instrument quantifies the multifactorial point-in-time disease burden for individual patients and groups of patients in a clinical trial.[1] Given their extensive validation process, study data collected using this instrument can be considered during future