Phase 2 N=28 Treatment

Impact of Nuedexta on Bulbar Physiology and Function in ALS

Amyotrophic Lateral Sclerosis

Bottom Line

View on ClinicalTrials.gov: NCT03883581 ↗

Enrolled (actual)

Serious AEs

3.6%

Results posted

Mar 2023

Primary outcome: Primary: Change in Dynamic Imaging Grade of Swallowing Toxicity — 3; 7 Participants — p=0.08

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: dextromethorphan HBr and quinidine sulfate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: Sep 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Dynamic Imaging Grade of Swallowing Toxicity	3; 7	0.08
PRIMARY Change in Speech Intelligibility	71.52; 73.06	0.647
PRIMARY Change in Patient-reported Outcome: Center for Neurologic Study-Bulbar Function Scale (CNS-BFS)	56.87; 54.13	0.103
PRIMARY Change in ALSFRS-R Bulbar Subscale Score	7.47; 8.39	0.0004 sig
PRIMARY Bamboo Passage Reading Duration (in Seconds)	66.19; 65.33	0.103

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.

Eligibility Criteria

Inclusion Criteria

Diagnosis of probable-definite ALS (El-Escorial Criterion);
ALSFRS-R Bulbar subscale score <10
Bamboo oral reading speaking rate <140 words per minute
No allergies to barium sulfate.

Exclusion Criteria

Treatment for sialorrhea within the past 3 months that includes either Botox or radiation treatment
Participation in another disease modifying study targeting bulbar or cough function
Use of invasive mechanical ventilation/presence of tracheostomy
Advanced frontotemporal dementia or significant cognitive dysfunction
Nil per oral status for feeding (i.e., NPO, nothing by mouth)
Previously prescribed Nuedexta. Additionally, if participants are taking Riluzole or other medications to control sialorrhea, they must be on a stable dose for at least 30 days prior to enrollment in the current study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03883581). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.