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| ID | Type | Description | Link |
|---|---|---|---|
| 3FKVAD | Other Grant/Funding Number | ALSA |
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| Name | Class |
|---|---|
| ALS Association | OTHER |
| State University of New York - Upstate Medical University | OTHER |
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The purpose of this study is to determine whether Nuedexta is effective in the treatment of symptoms (impaired speech, swallowing, and saliva control)associated with Amyotrophic Lateral Sclerosis (ALS).
Muscle weakness, the cardinal feature of ALS, leads to progressive loss of motor function affecting the limbs, tongue, respiratory and pharyngeal muscles. Symptomatic treatments such as the placement of a feeding tube, can compensate for the inability to swallow. Riluzole, the only approved treatment for ALS, may slow disease progression but no treatment is curative and none have improved function.
Unexpectedly, Nuedexta®, approved for the treatment of labile emotionality that occurs in association with ALS and other neurological disorders, has been observed to improve bulbar function, primarily speech and swallowing, in a number of neurological disorders, including ALS. The basis for this is conjectural but likely due to a direct effect of the drug on motor neurons in the part of the brain that controls speech and swallowing. The same part of the brain appears to modulate the expression of emotions and interestingly the site of action of the drug is the same as a site that has been implicated in a juvenile form of ALS.
This is a multicenter, randomized double-blind, placebo controlled, cross over study evaluating the palliative effect of Nuedexta® on bulbar dysfunction. It is expected that approximately 60 ALS patients from 7 clinical centers in the US will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nuedexta then Matching Placebo | Other | 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). |
|
| Matching Placebo then Nuedexta | Other | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nuedexta | Drug | Nuedexta PO (by mouth) for 28 ± 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bulbar Function Scale (CNS-BFS) Total Score | 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. 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] The scale was modeled on the Center for Neurologic Study Emotional Lability Scale (CNS-LS) that has been a robust endpoint in four clinical trials. The scale was validated in a large population of ALS patients (n=122) and detects impaired bulbar function at a sensitivity of 90% and a specificity of 0.97%. Test re-test correlation was 0.92% at six-months (n=53). | Average between Screening Visit to Visit 3 |
| Bulbar Function Scale (CNS-BFS) Sialorrhea Score | 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. Scores for each question range from 1 (does not apply) to 5 (applies most of the time). The higher the score, the worse the salivation (sialorrhea). There are 7 salivation (sialorrhea) questions, with a score range of 7 to 35. | Average between Screening Visit to Visit 3 |
| Bulbar Function Scale (CNS-BFS) Speech Score | 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. 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. There are 7 speech questions, with a score range of 7 to 35. | Average between Screening Visit to Visit 3 |
| Bulbar Function Scale (CNS-BFS) Swallowing Score | 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. Scores for each question range from 1 (does not apply) to 5 (applies most of the time). The higher the score, the worse the swallowing. There are 7 swallowing questions, with a score range of 7 to 35. |
| Measure | Description | Time Frame |
|---|---|---|
| Center for Neurologic Study - Lability Scale (CNS-LS) Total Score | 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. The higher the score, the worse the PBA. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard A Smith, MD | Center for Neurologic Study (CNS) | Principal Investigator |
| Jeremy Shefner, MD, PhD | Barrow Neurological Institute | Principal Investigator |
| Merit E Cudkowicz, MD, MSc | Massachusetts General Hospital (MGH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Pacific Medical Center | San Francisco | California | 94115 | United States | ||
| Georgetown University Medical Center |
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| Label | URL |
|---|---|
| Northeast ALS Consortium Website | View source |
| ALS Association Website | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nuedexta Then Matching Placebo | 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 |
| FG001 | Matching Placebo Then Nuedexta | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All patients who signed a consent form and had a baseline visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bulbar Function Scale (CNS-BFS) Total Score | 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. 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] The scale was modeled on the Center for Neurologic Study Emotional Lability Scale (CNS-LS) that has been a robust endpoint in four clinical trials. The scale was validated in a large population of ALS patients (n=122) and detects impaired bulbar function at a sensitivity of 90% and a specificity of 0.97%. Test re-test correlation was 0.92% at six-months (n=53). | Includes all participants that received at least one dose of intervention. | Posted | Least Squares Mean | Standard Error | units on a scale | Average between Screening Visit to Visit 3 |
|
28 days +/- 3 days for each Intervention.
Safety population included all participants who received at least one dose of intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Drug (Neudexta) | Includes all subjects that took the active drug (Neudexta) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Smith, MD | Center for Neurological Study | 858-455-5463 | cnsonline@ymail.com |
Not provided
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
Not provided
Not provided
| ID | Term |
|---|---|
| C507057 | dextromethorphan - quinidine combination |
| D003915 | Dextromethorphan |
| D011802 | Quinidine |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Matching Placebo | Drug | matching placebo PO (by mouth) for 28 ± 3 days |
|
|
| Average between Screening Visit to Visit 3 |
| Average between Screening Visit to Visit 3 |
| ALS Functional Rating Scale- Revised (ALSFRS-R) Total Score | 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. | Average between Screening Visit to Visit 3 |
| Visual Analog Scale - Speech Scores | Visual analog scales are useful for measuring complex clinical events and offer the advantage of self-administration and responsiveness to change over time. The scales designed for this study inventory three domains of bulbar function: speech, swallowing and salivation (sialorrhea). For each of these, subjects score themselves by indicating their level of function on a scale of 1 (severe impairment) to 10 (normal). Scores range from 1 to 10; the higher the score, the more normal the function. | Average between Baseline Visit to Visit 3 |
| Ashworth Spasticity Scale Score - Right Arm | This is a standard measure for spasticity that has been used in numerous ALS clinical trials to assess spasticity due to upper motor neuron dysfunction in ALS. Data is generated from the clinical exam and scored from 1-5, the lowest score indicating normal tone and the highest muscle rigidity. | Average between Baseline Visit to Visit 3 |
| Timed Reading of Test Paragraph Result | Subjects will be asked to read 'The Rainbow Passage' a commonly used test paragraph utilized by speech pathologists to assess speech rate (words/minute). Study staff will time the subject to determine how many words the subject reads per minute. It is used primarily because it contains every sound in the English language. Subjects will also be observed for loudness, nasality, and intelligibility. | Average between Baseline Visit to Visit 3 |
| Average Water Swallowing Test (WST) | The Water Swallowing Test (WST) estimates swallowing speed, a useful and reproducible measure. While sitting, subjects are asked to drink 30 milliliters (mL) of liquid. The time for subjects to complete this task is a sensitive measure for the detection of swallowing dysfunction and is a simple measure for serial assessment of subjects. The test will be completed three times, with the best two scores recorded to obtain an average score. Following completion of the WST, the subject's swallowing abilities (choking, spillage, and effort) will be observed. | Average between Baseline Visit to Visit 3 |
| Visual Analog Scale - Swallowing Score | Visual analog scales are useful for measuring complex clinical events and offer the advantage of self-administration and responsiveness to change over time. The scales designed for this study inventory three domains of bulbar function: speech, swallowing and salivation (sialorrhea). For each of these, subjects score themselves by indicating their level of function on a scale of 1 (severe impairment) to 10 (normal). Scores range from 1 to 10; the higher the score, the more normal the function. | Average between Baseline Visit to Visit 3 |
| Visual Analog Scale - Salivation (Sialorrhea) Score | Visual analog scales are useful for measuring complex clinical events and offer the advantage of self-administration and responsiveness to change over time. The scales designed for this study inventory three domains of bulbar function: speech, swallowing and salivation (sialorrhea). For each of these, subjects score themselves by indicating their level of function on a scale of 1 (severe impairment) to 10 (normal). Scores range from 1 to 10; the higher the score, the more normal the function. | Average between Baseline Visit to Visit 3 |
| Average Solids Swallowing Test | The Time Swallowing Test assesses the subject's ability to swallow solids. For this test, the subject will be asked to consume a tablespoon of cereal containing 5 cheerios. The subject will be instructed to close their mouth, chew and subsequently swallow the bolus. The time to complete this task will be recorded. The test will be completed three times to obtain an average score. | Average between Baseline Visit to Visit 3 |
| Ashworth Spasticity Scale Score - Left Arm | This is a standard measure for spasticity that has been used in numerous ALS clinical trials to assess spasticity due to upper motor neuron dysfunction in ALS. Data is generated from the clinical exam and scored from 1-5, the lowest score indicating normal tone and the highest muscle rigidity. | Average between Baseline Visit to Visit 3 |
| Ashworth Spasticity Scale Score - Right Leg | This is a standard measure for spasticity that has been used in numerous ALS clinical trials to assess spasticity due to upper motor neuron dysfunction in ALS. Data is generated from the clinical exam and scored from 1-5, the lowest score indicating normal tone and the highest muscle rigidity. | Average between Baseline Visit to Visit 3 |
| Ashworth Spasticity Scale Score - Left Leg | This is a standard measure for spasticity that has been used in numerous ALS clinical trials to assess spasticity due to upper motor neuron dysfunction in ALS. Data is generated from the clinical exam and scored from 1-5, the lowest score indicating normal tone and the highest muscle rigidity. | Average between Baseline Visit to Visit 3 |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| Saint Mary's Health Care | Grand Rapids | Michigan | 49503 | United States |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | United States |
| Neurology Associates, P.C. | Lincoln | Nebraska | 68506 | United States |
| The Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Providence ALS Center | Portland | Oregon | 97213 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline CNS-BFS Total Score | 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] | Mean | Standard Deviation | units on a scale |
|
| Baseline ALSFRS-R Total Score | 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. | Mean | Standard Deviation | units on a scale |
|
| Baseline CNS Lability Scale Total Score | 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Matching Placebo |
|
|
|
| Primary | Bulbar Function Scale (CNS-BFS) Sialorrhea Score | 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. Scores for each question range from 1 (does not apply) to 5 (applies most of the time). The higher the score, the worse the salivation (sialorrhea). There are 7 salivation (sialorrhea) questions, with a score range of 7 to 35. | Includes all participants that received at least one dose of intervention. | Posted | Least Squares Mean | Standard Error | units on a scale | Average between Screening Visit to Visit 3 |
|
|
|
| Primary | Bulbar Function Scale (CNS-BFS) Speech Score | 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. 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. There are 7 speech questions, with a score range of 7 to 35. | Includes all participants that received at least one dose of intervention. | Posted | Least Squares Mean | Standard Error | units on a scale | Average between Screening Visit to Visit 3 |
|
|
|
| Primary | Bulbar Function Scale (CNS-BFS) Swallowing Score | 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. Scores for each question range from 1 (does not apply) to 5 (applies most of the time). The higher the score, the worse the swallowing. There are 7 swallowing questions, with a score range of 7 to 35. | Includes all participants that received at least one dose of intervention. | Posted | Least Squares Mean | Standard Error | units on a scale | Average between Screening Visit to Visit 3 |
|
|
|
| Secondary | Center for Neurologic Study - Lability Scale (CNS-LS) Total Score | 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. The higher the score, the worse the PBA. | Includes all participants that received at least one dose of intervention. | Posted | Least Squares Mean | Standard Error | units on a scale | Average between Screening Visit to Visit 3 |
|
|
|
|
| Secondary | ALS Functional Rating Scale- Revised (ALSFRS-R) Total Score | 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. | Includes all participants that received at least one dose of intervention. | Posted | Least Squares Mean | Standard Error | units on a scale | Average between Screening Visit to Visit 3 |
|
|
|
| Secondary | Visual Analog Scale - Speech Scores | Visual analog scales are useful for measuring complex clinical events and offer the advantage of self-administration and responsiveness to change over time. The scales designed for this study inventory three domains of bulbar function: speech, swallowing and salivation (sialorrhea). For each of these, subjects score themselves by indicating their level of function on a scale of 1 (severe impairment) to 10 (normal). Scores range from 1 to 10; the higher the score, the more normal the function. | Includes all participants that received at least one dose of intervention. | Posted | Least Squares Mean | Standard Error | units on a scale | Average between Baseline Visit to Visit 3 |
|
|
|
| Secondary | Ashworth Spasticity Scale Score - Right Arm | This is a standard measure for spasticity that has been used in numerous ALS clinical trials to assess spasticity due to upper motor neuron dysfunction in ALS. Data is generated from the clinical exam and scored from 1-5, the lowest score indicating normal tone and the highest muscle rigidity. | Includes all participants that received at least one dose of intervention. | Posted | Least Squares Mean | Standard Deviation | units on a scale | Average between Baseline Visit to Visit 3 |
|
|
|
| Secondary | Timed Reading of Test Paragraph Result | Subjects will be asked to read 'The Rainbow Passage' a commonly used test paragraph utilized by speech pathologists to assess speech rate (words/minute). Study staff will time the subject to determine how many words the subject reads per minute. It is used primarily because it contains every sound in the English language. Subjects will also be observed for loudness, nasality, and intelligibility. | Includes all participants that received at least one dose of intervention. | Posted | Least Squares Mean | Standard Error | words per minute | Average between Baseline Visit to Visit 3 |
|
|
|
| Secondary | Average Water Swallowing Test (WST) | The Water Swallowing Test (WST) estimates swallowing speed, a useful and reproducible measure. While sitting, subjects are asked to drink 30 milliliters (mL) of liquid. The time for subjects to complete this task is a sensitive measure for the detection of swallowing dysfunction and is a simple measure for serial assessment of subjects. The test will be completed three times, with the best two scores recorded to obtain an average score. Following completion of the WST, the subject's swallowing abilities (choking, spillage, and effort) will be observed. | Includes all participants that received at least one dose of intervention. | Posted | Least Squares Mean | Standard Error | seconds | Average between Baseline Visit to Visit 3 |
|
|
|
| Secondary | Visual Analog Scale - Swallowing Score | Visual analog scales are useful for measuring complex clinical events and offer the advantage of self-administration and responsiveness to change over time. The scales designed for this study inventory three domains of bulbar function: speech, swallowing and salivation (sialorrhea). For each of these, subjects score themselves by indicating their level of function on a scale of 1 (severe impairment) to 10 (normal). Scores range from 1 to 10; the higher the score, the more normal the function. | Includes all participants that received at least one dose of intervention. | Posted | Least Squares Mean | Standard Error | units on a scale | Average between Baseline Visit to Visit 3 |
|
|
|
| Secondary | Visual Analog Scale - Salivation (Sialorrhea) Score | Visual analog scales are useful for measuring complex clinical events and offer the advantage of self-administration and responsiveness to change over time. The scales designed for this study inventory three domains of bulbar function: speech, swallowing and salivation (sialorrhea). For each of these, subjects score themselves by indicating their level of function on a scale of 1 (severe impairment) to 10 (normal). Scores range from 1 to 10; the higher the score, the more normal the function. | Includes all participants that received at least one dose of intervention. | Posted | Least Squares Mean | Standard Error | units on a scale | Average between Baseline Visit to Visit 3 |
|
|
|
| Secondary | Average Solids Swallowing Test | The Time Swallowing Test assesses the subject's ability to swallow solids. For this test, the subject will be asked to consume a tablespoon of cereal containing 5 cheerios. The subject will be instructed to close their mouth, chew and subsequently swallow the bolus. The time to complete this task will be recorded. The test will be completed three times to obtain an average score. | Includes all participants that received at least one dose of intervention. | Posted | Least Squares Mean | Standard Error | seconds | Average between Baseline Visit to Visit 3 |
|
|
|
| Secondary | Ashworth Spasticity Scale Score - Left Arm | This is a standard measure for spasticity that has been used in numerous ALS clinical trials to assess spasticity due to upper motor neuron dysfunction in ALS. Data is generated from the clinical exam and scored from 1-5, the lowest score indicating normal tone and the highest muscle rigidity. | Includes all participants that received at least one dose of intervention. | Posted | Least Squares Mean | Standard Deviation | units on a scale | Average between Baseline Visit to Visit 3 |
|
|
|
| Secondary | Ashworth Spasticity Scale Score - Right Leg | This is a standard measure for spasticity that has been used in numerous ALS clinical trials to assess spasticity due to upper motor neuron dysfunction in ALS. Data is generated from the clinical exam and scored from 1-5, the lowest score indicating normal tone and the highest muscle rigidity. | Includes all participants that received at least one dose of intervention. | Posted | Least Squares Mean | Standard Deviation | units on a scale | Average between Baseline Visit to Visit 3 |
|
|
|
| Secondary | Ashworth Spasticity Scale Score - Left Leg | This is a standard measure for spasticity that has been used in numerous ALS clinical trials to assess spasticity due to upper motor neuron dysfunction in ALS. Data is generated from the clinical exam and scored from 1-5, the lowest score indicating normal tone and the highest muscle rigidity. | Includes all participants that received at least one dose of intervention. | Posted | Least Squares Mean | Standard Deviation | units on a scale | Average between Baseline Visit to Visit 3 |
|
|
|
| 1 |
| 58 |
| 21 |
| 58 |
| EG001 | Matching Placebo | Includes all subjects that took matching placebo | 0 | 57 | 4 | 57 |
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D002930 | Cinchona Alkaloids |
| D011812 | Quinuclidines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D002241 | Carbohydrates |