Clinical Trial Nuedexta in Subjects With ALS

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Center for Neurologic Study, La Jolla, California,
• Collaborators: ALS Association; State University of New York - Upstate Medical University
• Treatments: Dextromethorphan; Quinidine

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