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Impact of Nuedexta on Bulbar Physiology and Function in ALS
Gainesville, FL
Phase 1 & 2
Waitlist Available
Led By Lauren Tabor, PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; day 30
Awards & highlights
No Placebo-Only Group
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.
See full description
Eligible Conditions
- Amyotrophic Lateral Sclerosis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline; day 30
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; day 30
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Bamboo Passage Reading Duration (in Seconds)
Change in ALSFRS-R Bulbar Subscale Score
Change in Dynamic Imaging Grade of Swallowing Toxicity
+2 moreSide effects data
From 2021 Phase 1 & 2 trial • 28 Patients • NCT038835814%
Prolonged hospitalization due to left leg DVT
4%
Fainting
4%
Diarrhea
4%
Headache
4%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
ALS Individuals With Bulbar Dysfunction
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ALS individuals with bulbar dysfunctionExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dextromethorphan HBr and quinidine sulfate
2019
Completed Phase 2
~30
Find a Location
Closest Location:University of Florida· Gainesville, FL
Who is running the clinical trial?
ALS AssociationOTHER
45 Previous Clinical Trials
17,437 Total Patients Enrolled
45 Trials studying Amyotrophic Lateral Sclerosis
17,437 Patients Enrolled for Amyotrophic Lateral Sclerosis
University of FloridaLead Sponsor
1,415 Previous Clinical Trials
971,107 Total Patients Enrolled
8 Trials studying Amyotrophic Lateral Sclerosis
5,307 Patients Enrolled for Amyotrophic Lateral Sclerosis
Holy Cross Hospital, FloridaOTHER
6 Previous Clinical Trials
369 Total Patients Enrolled
1 Trials studying Amyotrophic Lateral Sclerosis
90 Patients Enrolled for Amyotrophic Lateral Sclerosis
Lauren Tabor, PhDPrincipal InvestigatorPhil Smith Neuroscience Institute at Holy Cross Hospital
Emily Plowman, PhDPrincipal InvestigatorUniversity of Florida
5 Previous Clinical Trials
419 Total Patients Enrolled
1 Trials studying Amyotrophic Lateral Sclerosis
109 Patients Enrolled for Amyotrophic Lateral Sclerosis