Clinical Trial Nuedexta in Subjects With ALS

Completed · Phase 2 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis (ALS)

In brief

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).

Key facts

Study ID

NCT01806857

Run by

Center for Neurologic Study, La Jolla, California,

People needed

90

Starts

2013-04-01

Expected to finish

2015-03-01

Last updated by the study team

2017-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• California Pacific Medical Center — San Francisco, California, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Saint Mary's Health Care — Grand Rapids, Michigan, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Neurology Associates, P.C. — Lincoln, Nebraska, United States
• The Cleveland Clinic — Cleveland, Ohio, United States
• Providence ALS Center — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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