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Riluzole Oral Soluble Film Safety and Tolerability in Amyotrophic Lateral Sclerosis

ALS Clinical Trial

Official title:
A Multi-Center, Open Label Study to Assess the Safety and Tolerability of Riluzole Oral Soluble Film in Subjects With Amyotrophic Lateral Sclerosis Over 12 Weeks of Twice Daily Treatment.

Clinical Trial 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.

Clinical Trial Description

The total study participant time is expected to be approximately 14 weeks from time of screening to completion of study. Subjects will be instructed on the use of ROSF and receive the first dose of ROSF under supervision of the investigator during Visit 1.Subjects will then continue on ROSF 50mg twice daily for 12 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03457753
Study type Interventional
Source Aquestive Therapeutics
Contact
Status Withdrawn
Phase Phase 2
Start date March 1, 2018
Completion date March 27, 2018
View Details
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