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The Experimental Treatment of Bulbar Dysfunction in Amyotrophic Lateral Sclerosis (ALS)

Study Focus:
The purpose of this study is to determine whether Nuedexta® improves speech, swallowing and saliva control in subjects with ALS
Amyotrophic Lateral Sclerosis (ALS), Sporadic ALS, Familial ALS
Study Category:
Drug Trial
Study Status:
Phase II
Interventional Trial
with active agents/drugs & a placebo
Funding Source:
ALS Association and Northeast ALS (NEALS) Consortium
Study Chair(s)/Principal Investigator(s):
Merit Cudkowicz, MD, MSc (Massachusetts General Hospital)
Richard A. Smith, MD (Center for Neurologic Study, La Jolla, CA) ID:
NEALS Affiliated?
Study Summary:
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. Since the effect of Nuedexta® on speech and swallowing has not been rigorously evaluated, a clinical trial has been designed to scientifically determine the effect of Nuedexta® on bulbar functions (speech, swallowing and salivation).

Approximately 60 eligible subjects with ALS will be recruited from multiple centers in the US. Subjects will be treated for 28 days (±3 days) with either Nuedexta® or placebo. A 10-15 day washout period will then occur. After the washout period, subjects will be crossed-over to the other treatment arm for an additional 28 days (± 3 days) of treatment. A follow-up telephone call will occur approximately 28 days after completion of the study.
Participant Duration:
Subjects will take study treatment for approximately 2 months. Subjects will have 5 in-person visits and 1 telephone visit during the study.
# of Subjects:
Enrollment Start Date:
Enrollment End Date:
Posting Last Modified Date:
Date Study Added to
More information:
Eligibility Criteria
Male & Female
Minimum Age:
Min Vital Capacity (% predicted normal):
Time since Symptom Onset:
Not applicable
Time since Diagnosis:
Not applicable
Can participants use Riluzole?
Coordinating Center
Contact Information
Brenda Thornell
Massachusetts General Hospital
165 Cambridge Street
Boston, Massachusetts 02114
Other Eligibility Criteria:
Inclusion Criteria
Study subjects meeting all of the following criteria will be allowed to enroll in the study:

1. ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by revised El Escorial criteria.
2. Age 18 years or older.
3. 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.
4. Capable of providing informed consent and following trial procedures.
5. Geographic accessibility to the site.
6. Women must not be able to become pregnant for the duration of the study and must be willing to be on two contraceptive therapies.
7. Slow vital capacity (SVC) measure ≥50% of predicted for gender, height, and age at the screening visit.
8. Must be able to swallow capsules throughout the course of the study, according to PI judgment.
9. 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 (riluzole-naïve subjects are permitted in the study).
10. 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)
11. Must be able to safely swallow at least 30cc of water for the water swallowing test

Exclusion Criteria
Study subjects meeting any of the following criteria during screening evaluations will be excluded from entry into the study:

1. Prior use of Nuedexta®.
2. Current use of dextromethorphan, quinidine, quinine, mefloquine or opioids.
3. History of quinidine, quinine, or mefloquine, or opiate-induced thrombocytopenia, hepatitis, or other hypersensitivity reactions.
4. History of known sensitivity or intolerability to dextromethorphan.
5. Use of a monoamine oxidase inhibitor (MAOI) or within 14 days of stopping an MAOI.
6. Prolonged QT interval (QTc > 450 msec for women or >430 msec for men) , congenital long QT syndrome, history suggestive of torsades de pointes, or heart failure.
7. Complete atrioventricular (AV) block without implanted pacemaker, or subjects at high risk of complete AV block.
8. Concomitant use with drugs that both prolong QT interval and are metabolized by CYP2D6 (i.e., thioridazine or pimozide).
9. Exposure to any other experimental agent (off-label use or investigational) within 30 days prior to Baseline Visit.
10. Invasive ventilator dependence, such as tracheostomy.
11. Any history of either substance abuse within the past year, unstable psychiatric disease, cognitive impairment, or dementia, according to PI judgment.
12. Placement and usage of feeding tube.
13. Pregnant women or women currently breastfeeding
14. Unable to turn diaphragmatic pacing device off during swallowing tests
15. Salivatory Botox within 90 days (3 months) of screening
16. Salivatory radiation within 180 days (6 months) of screening

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