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NCT03679975 · ClinicalTrials.gov registry record · Phase 2
Riluzole Oral Soluble Film (ROSF) Swallowing Safety in Amyotrophic Lateral Sclerosis (ALS)
A Phase 2 study, sponsored by Aquestive Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT03679975: Clinical Trial Phase 2 study, sponsored by Aquestive Therapeutics.
NCT03679975 is a Phase 2 study that was terminated before completion, run by Aquestive Therapeutics. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03679975, a Phase 2 study, was terminated before completion, sponsored by Aquestive Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
The primary objective is to evaluate the effect, if any, of a single 50 mg dose of Riluzole Oral Soluble Film (ROSF) on swallowing safety in individuals with amyotrophic lateral sclerosis.
Primary Outcome
Swallowing safety was assessed using the gold standard Videofluoroscopic Swallowing Study (VFSS) to allow direct visualization of the swallowing process and any episodes of penetration or aspiration were quantified using the validated Penetration Aspiration Scale (PAS). 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. The assessment is perf
Interventions
- DRUG Riluzole Oral Soluble film (ROSF) 50 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2018-04-04 |
| Est. Completion | 2018-12-21 |
| Phase | Phase 2 |
Why NCT03679975 stopped before completion
NCT03679975 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Riluzole Oral Soluble film (ROSF) 50 mg is the first listed.
NCT03679975 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03679975 about?
NCT03679975 is a clinical study titled "Riluzole Oral Soluble Film (ROSF) Swallowing Safety in Amyotrophic Lateral Sclerosis (ALS)". The primary objective is to evaluate the effect, if any, of a single 50 mg dose of Riluzole Oral Soluble Film (ROSF) on swallowing safety in individuals with amyotrophic lateral sclerosis.
What is the current status of trial NCT03679975?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2018-04-04. Estimated completion is 2018-12-21.
What interventions are being tested in trial NCT03679975?
The interventions under investigation include: Riluzole Oral Soluble film (ROSF) 50 mg (DRUG).
Who is sponsoring clinical trial NCT03679975?
This trial is sponsored by Aquestive Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03679975's enrollment target sits among peer trials
9 1989th of 2000 higher than 11 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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