CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
dextromethorphan HBr and quinidine sulfatedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03883581
NCT03883581Phase 2Completed
CompareCT.gov

Impact of Nuedexta on Bulbar Physiology and Function in ALS

University of Florida·interventional·Posted Mar 21, 2019·Updated Mar 8, 2023

In Brief

A Phase 2 clinical trial evaluating dextromethorphan HBr and quinidine sulfate for Amyotrophic Lateral Sclerosis. Completed, enrolled 28 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyotrophic Lateral Sclerosis
CountriesUnited States
CollaboratorsHoly Cross Hospital, Florida, ALS Association

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedMar 21, 2019
Enrollment StartJul 25, 2019
Primary CompletionSep 13, 2021
Study CompletionNov 22, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 7.3 years ago

Interventions

dextromethorphan HBr and quinidine sulfatedrug

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.