A Single Center Study to Evaluate the Effect of Riluzole Oral Soluble Film on Swallowing Safety in Individuals With Amyotrophic Lateral Sclerosis (ALS)
Phase of Trial: Phase II
Latest Information Update: 29 Jan 2019
At a glance
- Drugs Riluzole (Primary)
- Indications Amyotrophic lateral sclerosis
- Focus Adverse reactions
- Acronyms ROSF
- Sponsors Aquestive Therapeutics
- 06 Nov 2018 Status changed from recruiting to discontinued, as reported in the Aquestive Therapeutics media release.
- 06 Nov 2018 According to an Aquestive Therapeutics media release, the company reached an agreement with the FDA to end the swallowing study, sooner than previously planned based on an analysis of the study's interim data. Topline results are expected to be reported in late 2018 and an NDA submission is expected in the first quarter of 2019.
- 27 Sep 2018 New trial record