Back to resultsClinical Trial Nuedexta in Subjects With ALS
Primary Purpose
Amyotrophic Lateral Sclerosis (ALS)
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nuedexta
Matching Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis (ALS) focused on measuring Amyotrophic lateral sclerosis, ALS, Nuedexta, Bulbar function, motor neurons
Eligibility Criteria
Inclusion Criteria:
- ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by revised El Escorial criteria
- Age 18 years or older
- Exhibits bulbar dysfunction manifested by dysarthria and/or dysphagia, according to PI judgment, exhibits a score of 55 or above on the CNS-Bulbar Function Scale
- Capable of providing informed consent and following trial procedures
- Geographic accessibility to the site
- Women must not be able to become pregnant for the duration of the study and must be willing to be on two contraceptive therapies
- Slow vital capacity (SVC) measure ≥50% of predicted for gender, height, and age at the screening visit
- Must be able to swallow capsules throughout the course of the study, according to PI judgment
- Subjects must not have taken riluzole for at least 30 days or be on a 50mg BID dose of riluzole for at least 30 days prior to randomization (subjects how have never taken riluzole are permitted in the study)
- Subjects taking anti-sialorrhea medication(s) must be on a stable dose for at least 30 days prior to randomization (anti-sialorrhea naïve subjects are permitted in the study)
- Must be able to safely swallow at least 30 milliliters (mLs) of water for the water swallowing test
Exclusion Criteria:
- Prior use of Nuedexta®
- Current use of dextromethorphan, quinidine, quinine, mefloquine or opioids
- History of quinidine, quinine, or mefloquine-induced thrombocytopenia, hepatitis, or other hypersensitivity reactions
- History of known sensitivity or intolerability to dextromethorphan
- Use of an mono amine oxidase inhibitor (MAOI) or within 14 days of stopping an MAOI
- Prolonged QT interval, congenital long QT syndrome, history suggestive of torsades de pointes, or heart failure
- Complete atrioventricular (AV) block without implanted pacemaker, or subjects at high risk of complete AV block
- Concomitant use with drugs that both prolong QT interval and are metabolized by cytochrome P 2D6 (CYP2D6) (i.e., thioridazine or pimozide)
- Exposure to any other experimental agent (off-label use or investigational) within 30 days prior to Baseline Visit
- Invasive ventilator dependence, such as tracheostomy
- Any history of either substance abuse within the past year, unstable psychiatric disease, cognitive impairment, or dementia, according to PI judgment
- Placement and/or usage of feeding tube
- Pregnant women or women currently breastfeeding
- Unable to turn diaphragm pacing device off during swallowing tests
- Salivatory Botox within 90 days (3 months) of screening
- Salivatory radiation within 180 days (6 months) of screening
Sites / Locations
- California Pacific Medical Center
- Georgetown University Medical Center
- Saint Mary's Health Care
- Hennepin County Medical Center
- Neurology Associates, P.C.
- The Cleveland Clinic
- Providence ALS Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Nuedexta then Matching Placebo
Matching Placebo then Nuedexta
Arm 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).
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).
Outcomes
Primary Outcome Measures
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).
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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 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.
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.
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 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.
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.
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.
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.
Full Information
NCT ID
NCT01806857
First Posted
March 5, 2013
Last Updated
February 3, 2017
Sponsor
Center for Neurologic Study, La Jolla, California,
Collaborators
ALS Association, State University of New York - Upstate Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01806857
Brief Title
Clinical Trial Nuedexta in Subjects With ALS
Official Title
The Experimental Treatment of Bulbar Dysfunction in Amyotrophic Lateral Sclerosis (ALS)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Center for Neurologic Study, La Jolla, California,
Collaborators
ALS Association, State University of New York - Upstate Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis (ALS)
Keywords
Amyotrophic lateral sclerosis, ALS, Nuedexta, Bulbar function, motor neurons
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nuedexta then Matching Placebo
Arm Type
Other
Arm 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).
Arm Title
Matching Placebo then Nuedexta
Arm Type
Other
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Nuedexta
Other Intervention Name(s)
dextromethorphan hydrobromide and quinidine sulfate
Intervention Description
Nuedexta PO (by mouth) for 28 ± 3 days
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Other Intervention Name(s)
sugar pill
Intervention Description
matching placebo PO (by mouth) for 28 ± 3 days
Primary Outcome Measure Information:
Title
Bulbar Function Scale (CNS-BFS) Total Score
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. 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).
Time Frame
Average between Screening Visit to Visit 3
Title
Bulbar Function Scale (CNS-BFS) Sialorrhea Score
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. 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.
Time Frame
Average between Screening Visit to Visit 3
Title
Bulbar Function Scale (CNS-BFS) Speech Score
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. 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.
Time Frame
Average between Screening Visit to Visit 3
Title
Bulbar Function Scale (CNS-BFS) Swallowing Score
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. 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.
Time Frame
Average between Screening Visit to Visit 3
Secondary Outcome Measure Information:
Title
Center for Neurologic Study - Lability Scale (CNS-LS) Total Score
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. The higher the score, the worse the PBA.
Time Frame
Average between Screening Visit to Visit 3
Title
ALS Functional Rating Scale- Revised (ALSFRS-R) Total Score
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.
Time Frame
Average between Screening Visit to Visit 3
Title
Visual Analog Scale - Speech Scores
Description
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.
Time Frame
Average between Baseline Visit to Visit 3
Title
Ashworth Spasticity Scale Score - Right Arm
Description
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.
Time Frame
Average between Baseline Visit to Visit 3
Title
Timed Reading of Test Paragraph Result
Description
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.
Time Frame
Average between Baseline Visit to Visit 3
Title
Average Water Swallowing Test (WST)
Description
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.
Time Frame
Average between Baseline Visit to Visit 3
Title
Visual Analog Scale - Swallowing Score
Description
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.
Time Frame
Average between Baseline Visit to Visit 3
Title
Visual Analog Scale - Salivation (Sialorrhea) Score
Description
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.
Time Frame
Average between Baseline Visit to Visit 3
Title
Average Solids Swallowing Test
Description
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.
Time Frame
Average between Baseline Visit to Visit 3
Title
Ashworth Spasticity Scale Score - Left Arm
Description
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.
Time Frame
Average between Baseline Visit to Visit 3
Title
Ashworth Spasticity Scale Score - Right Leg
Description
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.
Time Frame
Average between Baseline Visit to Visit 3
Title
Ashworth Spasticity Scale Score - Left Leg
Description
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.
Time Frame
Average between Baseline Visit to Visit 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by revised El Escorial criteria
Age 18 years or older
Exhibits bulbar dysfunction manifested by dysarthria and/or dysphagia, according to PI judgment, exhibits a score of 55 or above on the CNS-Bulbar Function Scale
Capable of providing informed consent and following trial procedures
Geographic accessibility to the site
Women must not be able to become pregnant for the duration of the study and must be willing to be on two contraceptive therapies
Slow vital capacity (SVC) measure ≥50% of predicted for gender, height, and age at the screening visit
Must be able to swallow capsules throughout the course of the study, according to PI judgment
Subjects must not have taken riluzole for at least 30 days or be on a 50mg BID dose of riluzole for at least 30 days prior to randomization (subjects how have never taken riluzole are permitted in the study)
Subjects taking anti-sialorrhea medication(s) must be on a stable dose for at least 30 days prior to randomization (anti-sialorrhea naïve subjects are permitted in the study)
Must be able to safely swallow at least 30 milliliters (mLs) of water for the water swallowing test
Exclusion Criteria:
Prior use of Nuedexta®
Current use of dextromethorphan, quinidine, quinine, mefloquine or opioids
History of quinidine, quinine, or mefloquine-induced thrombocytopenia, hepatitis, or other hypersensitivity reactions
History of known sensitivity or intolerability to dextromethorphan
Use of an mono amine oxidase inhibitor (MAOI) or within 14 days of stopping an MAOI
Prolonged QT interval, congenital long QT syndrome, history suggestive of torsades de pointes, or heart failure
Complete atrioventricular (AV) block without implanted pacemaker, or subjects at high risk of complete AV block
Concomitant use with drugs that both prolong QT interval and are metabolized by cytochrome P 2D6 (CYP2D6) (i.e., thioridazine or pimozide)
Exposure to any other experimental agent (off-label use or investigational) within 30 days prior to Baseline Visit
Invasive ventilator dependence, such as tracheostomy
Any history of either substance abuse within the past year, unstable psychiatric disease, cognitive impairment, or dementia, according to PI judgment
Placement and/or usage of feeding tube
Pregnant women or women currently breastfeeding
Unable to turn diaphragm pacing device off during swallowing tests
Salivatory Botox within 90 days (3 months) of screening
Salivatory radiation within 180 days (6 months) of screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard A Smith, MD
Organizational Affiliation
Center for Neurologic Study (CNS)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeremy Shefner, MD, PhD
Organizational Affiliation
Barrow Neurological Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Merit E Cudkowicz, MD, MSc
Organizational Affiliation
Massachusetts General Hospital (MGH)
Official's Role
Principal Investigator
Facility Information:
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington D.C.
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Saint Mary's Health Care
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Neurology Associates, P.C.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
The Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Providence ALS Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
http://www.alsconsortium.org/
Description
Northeast ALS Consortium Website
URL
http://www.alsa.org
Description
ALS Association Website
Learn more about this trial
Clinical Trial Nuedexta in Subjects With ALS
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