drugset / Trial / NCT03883581
Impact of Nuedexta on Bulbar Physiology and Function in ALS
Phase 1/2
Completed
28 enrolled
University of Florida
ALS Association · collabHoly Cross Hospital, Florida · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-07-25
- Primary completion
- 2021-09-13
- Completion
- 2021-11-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dextromethorphan | Unknown | 20 mg | Oral |
| Subject | Quinidine | Small molecule | 10 mg | Oral |