Clinical Trial Nuedexta in Subjects With ALS
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| ClinicalTrials.gov Identifier: NCT01806857 |
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Recruitment Status :
Completed
First Posted : March 7, 2013
Results First Posted : March 24, 2017
Last Update Posted : March 24, 2017
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Sponsor:
Center for Neurologic Study, La Jolla, California,
Collaborators:
ALS Association
State University of New York - Upstate Medical University
Information provided by (Responsible Party):
Richard A. Smith, MD, Center for Neurologic Study, La Jolla, California,
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| Study Type | Interventional |
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| Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
| Condition |
Amyotrophic Lateral Sclerosis (ALS) |
| Interventions |
Drug: Nuedexta Drug: Matching Placebo |
| Enrollment | 90 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | 90 subjects were consented for this trial, however, of the 90 that consented, 30 subjects were found to not meet eligibility criteria, and therefore were not treated. |
| Arm/Group Title | Nuedexta Then Matching Placebo | Matching Placebo Then Nuedexta |
|---|---|---|
 Arm/Group Description |
Subjects in this arm will receive treatment with Nuedexta first for 28 days (±3 days) and then crossed over to receive treatment with matching placebo for 28 days (±3 days). Nuedexta: Nuedexta PO (by mouth) for 28 ± 3 days Matching Placebo: matching placebo PO (by mouth) for 28 ± 3 days |
Subjects in this arm will receive treatment with matching placebo first for 28 days (±3 days) and then crossed over to receive treatment with Nuedexta for 28 days (±3 days). Nuedexta: Nuedexta PO (by mouth) for 28 ± 3 days Matching Placebo: matching placebo PO (by mouth) for 28 ± 3 days |
| Period Title: Overall Study | ||
| Started | 31 | 29 |
| Completed | 30 | 29 |
| Not Completed | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | All Study Participants | |
|---|---|---|
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Arm/Group Description |
[Not Specified] | |
| Overall Number of Baseline Participants | 60 | |
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Baseline Analysis Population Description |
All patients who signed a consent form and had a baseline visit.
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Age, Continuous
Mean (Inter-Quartile Range) Unit of measure: Years |
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| Number Analyzed | 60 participants | |
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58
(26 to 78)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 60 participants | |
| Female |
26 43.3%
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| Male |
34 56.7%
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Race/Ethnicity, Customized
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 60 participants |
| Hispanic or Latino | 0 | |
| Asian | 1 | |
| Black/African American | 2 | |
| Caucasian/White | 57 | |
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 60 participants |
| 60 | ||
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Baseline CNS-BFS Total Score
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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| Number Analyzed | 60 participants | |
| 58.15 (13.37) | ||
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[1]
Measure Description: The Center for Neurologic Study-Bulbar Function Scale (CNS-BFS) is a 21-item self report scale that assesses three domains of bulbar function: speech, swallowing and salivation (sialorrhea). Scores for each question range from 1 (does not apply) to 5 (applies most of the time). The higher the score, the worse the speech, swallowing and salivation (sialorrhea). [Range of score: 21-105]
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Baseline ALSFRS-R Total Score
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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| Number Analyzed | 60 participants | |
| 34.58 (6.95) | ||
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[1]
Measure Description: The ALSFRS-R is a quickly administered (5 min) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing.
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Baseline CNS Lability Scale Total Score
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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| Number Analyzed | 60 participants | |
| 13.67 (5.55) | ||
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[1]
Measure Description: The Center for Neurologic Study-Lability Scale (CNS-LS) is a 7-item self report scale that assesses pseudobulbar affect (PBA) by measuring the perceived frequency of PBA episodes (laughing or crying). Each item is scored using a 5-point Likert scale, from 1 (applies never) to 5 (applies most of the time). Scores range from 5-35.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Richard Smith, MD |
| Organization: | Center for Neurological Study |
| Phone: | 858-455-5463 |
| EMail: | cnsonline@ymail.com |
| Responsible Party: | Richard A. Smith, MD, Center for Neurologic Study, La Jolla, California, |
| ClinicalTrials.gov Identifier: | NCT01806857 |
| Other Study ID Numbers: |
2012P001274 3FKVAD ( Other Grant/Funding Number: ALSA ) |
| First Submitted: | March 5, 2013 |
| First Posted: | March 7, 2013 |
| Results First Submitted: | August 9, 2016 |
| Results First Posted: | March 24, 2017 |
| Last Update Posted: | March 24, 2017 |