Impact of Nuedexta on Bulbar Physiology and Function in ALS

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

July 25, 2019

Primary Completion Date

September 13, 2021

Study Completion Date

November 22, 2021

Conditions
Amyotrophic Lateral Sclerosis
Interventions
DRUG

dextromethorphan HBr and quinidine sulfate

All eligible and enrolled study participants will be administered the study drug, Nuedexta, as recommended by their treating neurologists.The drug will be administered per the efficacy and safety protocol, with no changes in administration method or recommended dose for individuals with ALS. Prior to commencing treatment with Nuedexta, participants will undergo a comprehensive bulbar evaluation of swallowing, airway protection, speech functions, and complete validated patient-reported surveys. Following 30 days of Nuedexta treatment, participants will be e-evaluated using the same battery of assessments.

Trial Locations (2)

32610

University of Florida, Gainesville

33308

Phil Smith Neuroscience Institute at Holy Cross Hospital, Fort Lauderdale

All Listed Sponsors
collaborator

Holy Cross Hospital, Florida

OTHER

collaborator

ALS Association

OTHER

lead

University of Florida

OTHER

NCT03883581 - Impact of Nuedexta on Bulbar Physiology and Function in ALS | Biotech Hunter | Biotech Hunter