Impact of Nuedexta on Bulbar Physiology and Function in ALS
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
Outcome
Mixed primary results
registry MEAN ALS Individuals With Bulbar Dysfunction: Pre Nuedexta: 7.47 (Standard Error 0.38) score on a scale NCT03883581 ↗
registry MEAN ALS Individuals With Bulbar Dysfunction: Post Nuedextaa: 8.39 (Standard Error 0.37) score on a scale NCT03883581 ↗
registry analysis (superiority test); ALS Individuals With Bulbar Dysfunction; p = 0.0004; Wilcoxon (Mann-Whitney) NCT03883581 ↗
registry analysis (superiority test); ALS Individuals With Bulbar Dysfunction; p = 0.647; Paired t test NCT03883581 ↗
registry analysis (superiority test); ALS Individuals With Bulbar Dysfunction; p = 0.08; Wilcoxon (Mann-Whitney) NCT03883581 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dextromethorphan | Unknown | 20 mg | Oral |
| Subject | Quinidine | Small molecule | 10 mg | Oral |