Clinical trial

Impact of Nuedexta on Bulbar Physiology and Function in ALS

Name

IRB201802938

Description

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.

Trial arms

Trial start

2019-07-25

Estimated PCD

2021-09-13

Trial end

2021-11-22

Status

Completed

Phase

Early phase I

Treatment

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.

Arms:

ALS individuals with bulbar dysfunction

Other names:

Nuedexta

Size

Primary endpoint

Change in Dynamic Imaging Grade of Swallowing Toxicity

Baseline; Day 30

Change in Speech Intelligibility

Baseline; Day 30

Change in Patient-reported Outcome: Center for Neurologic Study-Bulbar Function Scale (CNS-BFS)

Baseline; Day 30

Change in ALSFRS-R Bulbar Subscale Score

Baseline; Day 30

Bamboo Passage Reading Duration (in Seconds)

Baseline; Day 30

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 28, 'type': 'ACTUAL'}}

Updated at

2023-03-08

1 organization

1 product

1 indication

Organization

University of Florida

Product

Dextromethorphan + Quinidine

Indication

Amyotrophic lateral sclerosis