NCT03457753

Riluzole Oral Soluble Film Safety and Tolerability in Amyotrophic Lateral Sclerosis

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.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Aquestive Therapeutics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• ALS

Interventions

Type	Name	Description
DRUG	Riluzole Oral Soluble Film	Riluzole Oral Soluble Film (ROSF) containing Riluzole 50mg .

Timeline

• Start date: 2018-03-01
• Primary completion: 2018-03-27
• Completion: 2018-03-27
• First posted: 2018-03-08
• Last updated: 2019-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study