Impact of Nuedexta on Bulbar Physiology and Function in ALS
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|ClinicalTrials.gov Identifier: NCT03883581|
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : October 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Drug: dextromethorphan HBr and quinidine sulfate||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Nuedexta on Bulbar Physiology and Function in ALS|
|Actual Study Start Date :||July 25, 2019|
|Estimated Primary Completion Date :||December 1, 2020|
|Estimated Study Completion Date :||February 28, 2021|
Experimental: ALS individuals with bulbar dysfunction
Participants enrolled in this group will be prescribed dextromethorphan HBr and quinidine sulfate (Nuedexta) as recommended by their treating neurologist. 20 mg dextromethorphan HBr and 10mg quinidine sulfate will be administered orally with 1 capsule every day for the initial 7 days followed by 1 capsule every 12 hours for the remaining 23 days of the study. Participants will be evaluated 30 days apart to determine the impact of treatment.
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.
Other Name: Nuedexta
- Change in Dynamic Imaging Grade of Swallowing Toxicity [ Time Frame: Baseline; Day 30 ]The validated Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) will be performed on all collected videofluoroscopic swallowing studies to assess global swallowing function. The DIGEST total score is determined using the composite of individual airway safety and bolus efficiency subscores (range: 0-4). The DIGEST total is rated on a 5-point ordinal score ranging from 0 (no dysphagia) to 4 (life-threatening dysphagia).
- Change in Airway Physiologic Defense Capacity [ Time Frame: Baseline; Day 30 ]Peak expiratory cough flow will be collected during maximum effort voluntary cough testing. Peak expiratory cough flow is calculated as the flow rate (L/s/s) between the end point of the compression phase of cough to the point of maximum expiration. Three trials will be performed at each evaluation and the maximum flow rate of the three epochs will be utilized for statistical analysis.
- Change in Speech Intelligibility [ Time Frame: Baseline; Day 30 ]The Sentence Intelligibility Test (SIT) will be performed to assess the change in speaking intelligibility over the 30 day period. The primary outcome of the SIT will be the percentage of sentence intelligibility (%) during oral reading.
- Change in maximum isometric lingual strength [ Time Frame: Baseline; Day 30 ]The Iowa Oral Performance instrument will be utilized to assess maximum isometric lingual strength (kPa) at each evaluation. Three trials will be completed at each evaluation and the maximum of the three trials will be utilized for statistical analysis.
- Change in Patient-reported outcome: Center for Neurologic Study-Bulbar Function Scale (CNS-BFS) [ Time Frame: Baseline; Day 30 ]The CNS-BFS is a validated patient-reported scale that assess self-reported impairments in the domains of speech, salivation and swallowing. Each domain contains 7 questions with ratings ranging from 1-7 with 7 considered the worst, with total scores ranging from 21 (no impairment) - 112 (severe impairment in all domains).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883581
|Contact: Lauren DiBiase, MSemail@example.com|
|United States, Florida|
|Phil Smith Neuroscience Institute at Holy Cross Hospital||Recruiting|
|Fort Lauderdale, Florida, United States, 33308|
|Contact: Lauren Tabor, PhD 954-542-3429 firstname.lastname@example.org|
|University of Florida||Recruiting|
|Gainesville, Florida, United States, 32610|
|Contact: Lauren DiBiase, MS 352-273-8632 email@example.com|
|Principal Investigator:||Lauren Tabor, PhD||Phil Smith Neuroscience Institute at Holy Cross Hospital|
|Principal Investigator:||Emily Plowman, PhD||University of Florida|