Riluzole Oral Soluble Film Swallowing Safety in Amyotrophic Lateral Sclerosis (ROSF)
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|ClinicalTrials.gov Identifier: NCT03679975|
Recruitment Status : Terminated (The study is no longer required)
First Posted : September 21, 2018
Last Update Posted : January 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Drug: Riluzole Oral Soluble film (ROSF) 50 mg||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Approximately 30 subjects with ALS will be enrolled and undergo an instrumental evaluation of swallowing safety before and after administration of a single dose of the ROSF formulation containing 50 mg of Riluzole.|
|Masking:||None (Open Label)|
|Official Title:||A Single Center Study to Evaluate the Effect of Riluzole Oral Soluble Film on Swallowing Safety in Individuals With Amyotrophic Lateral Sclerosis (ALS)|
|Actual Study Start Date :||April 4, 2018|
|Actual Primary Completion Date :||September 26, 2018|
|Actual Study Completion Date :||December 21, 2018|
Experimental: Subjects with ALS
Subjects with a diagnosis of probable or definite ALS in accordance with the Revisited El-Escorial Criteria will be administered a single dose of the Riluzole Oral Soluble Film (ROSF) 50 mg.
Drug: Riluzole Oral Soluble film (ROSF) 50 mg
Enrolled subjects will undergo an instrumental evaluation of swallowing safety before and after administration of a single dose of the ROSF formulation containing 50 mg of riluzole.
Other Name: ROSF 50 mg
- Difference from baseline in Penetration Aspiration Scale (PAS) [ Time Frame: Before and after administration of ROSF 50 mg on day 1 (visit 1) ]The PAS is an 8 point validated scale of swallowing safety that takes into account both degree/level of airway invasion during swallowing and the patients' response to the penetration or aspiration episode. A score of 1 means the swallowed material does not enter the airway. A score of 8 means the material enters the airway passes below vocal folds and no effort is made to eject.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679975
|United States, Florida|
|University of Florida Center for Movement Disorders & Neuroscience|
|Gainesville, Florida, United States, 32607|