Impact of Nuedexta on Bulbar Physiology and Function in ALS

• Status: Active, not recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborators: ALS Association; Holy Cross Hospital, Florida
• Treatments: Dextromethorphan; Quinidine; Quinidine gluconate

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.