Trial · NCT03883581
Impact of Nuedexta on Bulbar Physiology and Function in ALS
NCT03883581, Phase 1, Phase 2, Completed, University of Florida; results first posted 2023-03-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Impact of Nuedexta on Bulbar Physiology and Function in ALS. Trials, record NCT03883581. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03883581
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Impact of Nuedexta on Bulbar Physiology and Function in ALS
- NCT number
- NCT03883581
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- University of Florida
- Conditions
- Amyotrophic Lateral Sclerosis
- Interventions
- dextromethorphan HBr and quinidine sulfate
- First posted
- 2019-03-21
- Last updated
- 2023-03-08
- Results first posted
- 2023-03-08
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Dynamic Imaging Grade of Swallowing Toxicity | 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). |
| Primary | Change in Speech Intelligibility | 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. |
| Primary | Change in Patient-reported Outcome: Center for Neurologic Study-Bulbar Function Scale (CNS-BFS) | 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 1-5 with 5 considered the worst. For the speech domain, individuals who are unable to speak are assigned a value of 6 for each item (speech domain ranges from 1-6). Total scores ranging from 21 (no impairment) - 112 (severe impairment in all domains). |
| Primary | Change in ALSFRS-R Bulbar Subscale Score | Baseline; Day 30 | The ALS Functional Rating Scale-Revised Bulbar subscore is an outcome comprised of questions 1-3 on the validated ALSFRS-R scale. These items rate speech, swallowing and salivation functions on a scale from 0-total loss of function to 4- no symptoms for a total score of 0 to 12. |
| Primary | Bamboo Passage Reading Duration (in Seconds) | Baseline; Day 30 | The Bamboo Passage is a 60-word reading passage that is commonly used to measure speech duration. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Dynamic Imaging Grade of Swallowing Toxicity | Baseline; Day 30 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Change in Speech Intelligibility | Baseline; Day 30 | Percent Intelligibility | MEAN | |
| PRIMARY | Change in Patient-reported Outcome: Center for Neurologic Study-Bulbar Function Scale (CNS-BFS) | Baseline; Day 30 | Score | MEAN | |
| PRIMARY | Change in ALSFRS-R Bulbar Subscale Score | Baseline; Day 30 | score on a scale | MEAN | |
| PRIMARY | Bamboo Passage Reading Duration (in Seconds) | Baseline; Day 30 | Seconds | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Dynamic Imaging Grade of Swallowing Toxicity | ALS Individuals With Bulbar Dysfunction | Pre Nuedexta DIGEST 0 (Normal) | 3 | Participants | |
| Change in Dynamic Imaging Grade of Swallowing Toxicity | ALS Individuals With Bulbar Dysfunction | Post Nuedexta DIGEST 0 (Normal) | 7 | Participants | |
| Change in Speech Intelligibility | ALS Individuals With Bulbar Dysfunction | Pre Nuedexta | 71.52 | Standard Error 6.62 | Percent Intelligibility |
| Change in Speech Intelligibility | ALS Individuals With Bulbar Dysfunction | Post Nuedexta | 73.06 | Standard Error 6.15 | Percent Intelligibility |
| Change in Patient-reported Outcome: Center for Neurologic Study-Bulbar Function Scale (CNS-BFS) | ALS Individuals With Bulbar Dysfunction | Pre Nuedexta | 56.87 | Standard Error 3.01 | Score |
| Change in Patient-reported Outcome: Center for Neurologic Study-Bulbar Function Scale (CNS-BFS) | ALS Individuals With Bulbar Dysfunction | Post Nuedexta | 54.13 | Standard Error 2.97 | Score |
| Change in ALSFRS-R Bulbar Subscale Score | ALS Individuals With Bulbar Dysfunction | Pre Nuedexta | 7.47 | Standard Error 0.38 | score on a scale |
| Change in ALSFRS-R Bulbar Subscale Score | ALS Individuals With Bulbar Dysfunction | Post Nuedextaa | 8.39 | Standard Error 0.37 | score on a scale |
| Bamboo Passage Reading Duration (in Seconds) | ALS Individuals With Bulbar Dysfunction | Pre Nuedexta | 66.19 | Standard Error 3.59 | Seconds |
| Bamboo Passage Reading Duration (in Seconds) | ALS Individuals With Bulbar Dysfunction | Post Nuedexta | 65.33 | Standard Error 3.59 | Seconds |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ALS Individuals With Bulbar Dysfunction | 28 | |
| Overall Study | COMPLETED | ALS Individuals With Bulbar Dysfunction | 24 | |
| Overall Study | NOT COMPLETED | ALS Individuals With Bulbar Dysfunction | 4 |
Source ClinicalTrials.gov
Adverse events5
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fainting | General disorders | ALS Individuals With Bulbar Dysfunction | 1 | 28 | 1 |
| other | Diarrhea | Gastrointestinal disorders | ALS Individuals With Bulbar Dysfunction | 1 | 28 | 1 |
| other | Headache | General disorders | ALS Individuals With Bulbar Dysfunction | 1 | 28 | 1 |
| other | Nausea | General disorders | ALS Individuals With Bulbar Dysfunction | 1 | 28 | 1 |
| serious | Prolonged hospitalization due to left leg DVT | General disorders | ALS Individuals With Bulbar Dysfunction | 1 | 28 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ALS Individuals With Bulbar Dysfunction | 0 | 28 |
| Total, other adverse events | ALS Individuals With Bulbar Dysfunction | 4 | 28 |
| Total, serious adverse events | ALS Individuals With Bulbar Dysfunction | 1 | 28 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03883581
GET https://conductscience.org/api/trials/v1/NCT03883581/registered