Amyotrophic Lateral Sclerosis (ALS)Phase 2NCT01806857
Clinical Trial Nuedexta in Subjects With ALS
A Phase 2 study testing Nuedexta in people with Amyotrophic Lateral Sclerosis (ALS), run by Center for Neurologic Study, La Jolla, California, at 7 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS)
- What is being tested?
- Nuedexta
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2013to Mar 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
The Cleveland Clinic
Cleveland, Ohio, 44195
Saint Mary's Health Care
Grand Rapids, Michigan, 49503
Neurology Associates, P.C.
Lincoln, Nebraska, 68506
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Providence ALS Center
Portland, Oregon, 97213
California Pacific Medical Center
San Francisco, California, 94115
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
About this study
Official title: The Experimental Treatment of Bulbar Dysfunction in Amyotrophic Lateral Sclerosis (ALS)
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).
Read the 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.
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Being tested
- Nuedexta, Matching Placebo
- Keywords
- Amyotrophic lateral sclerosis, ALS, Nuedexta, Bulbar function, motor neurons
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuedextaDrug
Also called dextromethorphan hydrobromide and quinidine sulfate
Nuedexta PO (by mouth) for 28 ± 3 days
Matching PlaceboDrug
Also called sugar pill
matching placebo PO (by mouth) for 28 ± 3 days
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Nuedexta; Drug: Matching Placebo |
| 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). Receives: Drug: Nuedexta; Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Average between Screening Visit to Visit 3
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Average between Baseline Visit to Visit 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Neurologic Study, La Jolla, California,
- Sponsor type
- University, hospital or other
- Collaborators
- ALS Association, State University of New York - Upstate Medical University
- Responsible party
- Principal investigator, Richard A. Smith, MD, Center for Neurologic Study, La Jolla, California,
- Investigators
- Richard A Smith, MD, Principal investigator, Center for Neurologic Study (CNS)Jeremy Shefner, MD, PhD, Principal investigator, Barrow Neurological InstituteMerit E Cudkowicz, MD, MSc, Principal investigator, Massachusetts General Hospital (MGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806857
- Sponsor's protocol ID
- 2012P001274
- Other IDs
- 3FKVAD
- Status last verified
- Feb 2017
- First submitted
- 5 Mar 2013
- Last updated
- 24 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Experimental Treatment of Bulbar Dysfunction in Amyotrophic Lateral Sclerosis (ALS)
- ClinicalTrials.gov ID
- NCT01806857
- Acronym / sponsor ID
- 2012P001274
- Conditions
- Amyotrophic Lateral Sclerosis (ALS)
- Keywords
- Amyotrophic lateral sclerosis, ALS, Nuedexta, Bulbar function, motor neurons
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Center for Neurologic Study, La Jolla, California,University, hospital or other
- Collaborators
- ALS Association, State University of New York - Upstate Medical University
- Study start
- Apr 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 7 Mar 2013 (estimated)
- Results
- Posted 24 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nuedexta then Matching Placebo | Other | Drug: Nuedexta, Drug: Matching PlaceboSubjects 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 | Drug: Nuedexta, Drug: Matching PlaceboSubjects 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NuedextaAlso: dextromethorphan hydrobromide and quinidine sulfateNuedexta PO (by mouth) for 28 ± 3 days | Drug | Matching Placebo then Nuedexta, Nuedexta then Matching Placebo |
| Matching PlaceboAlso: sugar pillmatching placebo PO (by mouth) for 28 ± 3 days | Drug | Matching Placebo then Nuedexta, Nuedexta then Matching Placebo |
Primary outcome
Bulbar Function Scale (CNS-BFS) Total Score
Time frame: Average between Screening Visit to Visit 3
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
Time frame: Average between Screening Visit to Visit 3
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
Time frame: Average between Screening Visit to Visit 3
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
Time frame: Average between Screening Visit to Visit 3
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.
12 secondary outcomes
Center for Neurologic Study - Lability Scale (CNS-LS) Total Score
Time frame: Average between Screening Visit to Visit 3
ALS Functional Rating Scale- Revised (ALSFRS-R) Total Score
Time frame: Average between Screening Visit to Visit 3
Visual Analog Scale - Speech Scores
Time frame: Average between Baseline Visit to Visit 3
Ashworth Spasticity Scale Score - Right Arm
Time frame: Average between Baseline Visit to Visit 3
Timed Reading of Test Paragraph Result
Time frame: Average between Baseline Visit to Visit 3
Average Water Swallowing Test (WST)
Time frame: Average between Baseline Visit to Visit 3
Visual Analog Scale - Swallowing Score
Time frame: Average between Baseline Visit to Visit 3
Visual Analog Scale - Salivation (Sialorrhea) Score
Time frame: Average between Baseline Visit to Visit 3
Average Solids Swallowing Test
Time frame: Average between Baseline Visit to Visit 3
Ashworth Spasticity Scale Score - Left Arm
Time frame: Average between Baseline Visit to Visit 3
Ashworth Spasticity Scale Score - Right Leg
Time frame: Average between Baseline Visit to Visit 3
Ashworth Spasticity Scale Score - Left Leg
Time frame: Average between Baseline Visit to Visit 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Northeast ALS Consortium WebsiteLink provided by the sponsor.
- ALS Association WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard A Smith, MD principal investigator
Center for Neurologic Study (CNS)
Jeremy Shefner, MD, PhD principal investigator
Barrow Neurological Institute
Merit E Cudkowicz, MD, MSc principal investigator
Massachusetts General Hospital (MGH)
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nuedexta in people with Amyotrophic Lateral Sclerosis (ALS), run by Center for Neurologic Study, La Jolla, California, at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bulbar Function Scale (CNS-BFS) Total Score (time frame: Average between Screening Visit to Visit 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2017.