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NCT03883581 · ClinicalTrials.gov registry record · Phase 1
Impact of Nuedexta on Bulbar Physiology and Function in ALS
A Phase 1 study of Amyotrophic Lateral Sclerosis, sponsored by University of Florida.
- Completed
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 2
- Study locations
NCT03883581: Completed Phase 1 study of Amyotrophic Lateral Sclerosis, sponsored by University of Florida.
NCT03883581 is a Phase 1 study of Amyotrophic Lateral Sclerosis that has completed, run by University of Florida. The registered enrollment target is 28 participants, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03883581, a Phase 1 study of Amyotrophic Lateral Sclerosis, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 2
- Study locations
Study Summary
Nuedexta is FDA approved for the treatment of pseudobulbar affect in ALS patients and anecdotal reports of improvements in speech, salivation or swallowing have been reported. However, no prospective study has been conducted to comprehensively examine and determine the physiologic impact of Nuedexta on both speech and swallowing physiology in a large group of ALS individuals. These data are needed in order to provide evidence-based guidance to the management of bulbar dysfunction in ALS.
Primary Outcome
The validated Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) will be performed on all collected videofluoroscopic swallowing studies to assess global swallowing function. The DIGEST total score is determined using the composite of individual airway safety and bolus efficiency subscores (range: 0-4). The DIGEST total is rated on a 5-point ordinal score ranging from 0 (no dysphagia) to 4 (life-threatening dysphagia).
Conditions Studied
Interventions
- DRUG dextromethorphan HBr and quinidine sulfate
Study Locations (2)
Florida
- Phil Smith Neuroscience Institute at Holy Cross Hospital - Fort Lauderdale
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2019-07-25 |
| Est. Completion | 2021-11-22 |
| Phase | Phase 1 |
What the finished NCT03883581 record still lists
NCT03883581 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which dextromethorphan HBr and quinidine sulfate is the first listed.
NCT03883581 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03883581 about?
NCT03883581 is a clinical study titled "Impact of Nuedexta on Bulbar Physiology and Function in ALS". Nuedexta is FDA approved for the treatment of pseudobulbar affect in ALS patients and anecdotal reports of improvements in speech, salivation or swallowing have been reported. However, no prospective study has been conducted to comprehensively examine and determine the physiologic impact of Nuedexta...
What is the current status of trial NCT03883581?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2019-07-25. Estimated completion is 2021-11-22.
What conditions does trial NCT03883581 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis.
What interventions are being tested in trial NCT03883581?
The interventions under investigation include: dextromethorphan HBr and quinidine sulfate (DRUG).
Who is sponsoring clinical trial NCT03883581?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03883581 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Amyotrophic Lateral Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03883581's enrollment target sits among peer trials
28 66th of 102 higher than 35 of 102 other Amyotrophic Lateral Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis 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.
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