Riluzole Oral Soluble Film Safety and Tolerability in Amyotrophic Lateral Sclerosis
Status:
Withdrawn
Trial end date:
2018-03-27
Target enrollment:
Participant gender:
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.