Riluzole Oral Soluble Film Safety and Tolerability in Amyotrophic Lateral Sclerosis
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|ClinicalTrials.gov Identifier: NCT03457753|
Recruitment Status : Withdrawn (The Sponsor stopped the study due to a change in study plans)
First Posted : March 8, 2018
Last Update Posted : September 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|ALS||Drug: Riluzole Oral Soluble Film||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This is a multi-center, open label safety and tolerability trial. Approximately twenty-five (25) individuals with amyotrophic lateral sclerosis (ALS) will be enrolled.|
|Masking:||None (Open Label)|
|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.|
|Estimated Study Start Date :||March 2018|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||October 2018|
Experimental: Subjects with ALS
Riluzole Oral Soluble Film (ROSF) 50 mg will be administered in subjects with ALS twice daily. It is intended that at least five (5) of the twenty-five (25) subjects enrolled will be subjects scoring greater than 20 on the Eating Assessment Tool (EAT-10) (representative of ALS patients reporting moderate swallowing impairments in a patient report validated scale).
Drug: Riluzole Oral Soluble Film
Riluzole Oral Soluble Film (ROSF) containing Riluzole 50mg .
Other Name: ROSF
- Change from baseline in NCI-CTC score at week 12 [ Time Frame: Week 12 (visit 3) ]The National Cancer Institute Common Toxicity Criteria (NCI-CTC) score will be used to evaluate the presence or level of oral cavity irritation on an oral examination, with a grading scale ranging from Grade 0 -5 (0 = no toxicity, 1 = painless ulcers, erythema, or mild soreness, 2 = painful erythema, edema, or ulcers but eating or swallowing possible, 3 = painful erythema, edema, or ulcers requiring intravenous hydration, 4 = severe ulceration, and 5 = death related to toxicity).
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): NCT03457753
|United States, Texas|
|Texas Neurology, P.A.|
|Dallas, Texas, United States, 75214|
|Principal Investigator:||Emily Plowman, PhD, CCC-SLP||University of Florida|
|Principal Investigator:||James Wymer, MD, PhD||University of Florida|