Riluzole Oral Soluble Film Safety and Tolerability in Amyotrophic Lateral Sclerosis

Summary

The primary objective of this study is to assess the safety and tolerability, with emphasis on the oral cavity, of ROSF (containing riluzole 50mg) in subjects with amyotrophic lateral sclerosis (ALS) administered twice daily for 12 weeks. Secondary objectives include (1) to record the subject's assessment of any difficulty taking riluzole administered as ROSF and any difficulty taking riluzole in the tablet formulation and (2) to record the relative preference, if any, of subjects and caretakers, for riluzole administered as ROSF vs. the riluzole tablet.

Timeline

Start

2018-03-01

Primary completion

2018-03-27

Completion

2018-03-27

Drugs

Indications