Clinical Trial Nuedexta in Subjects With ALS

Trial end date:
Target enrollment:
Participant gender:
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).
Phase 2
Accepts Healthy Volunteers?
Lead Sponsor:
Center for Neurologic Study, La Jolla, California,
ALS Association
State University of New York - Upstate Medical University
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

- 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

- 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