Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2025-12-24 @ 6:54 PM
NCT ID:
NCT01806857
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01806857
Study Brief:
Protocol Section:
NCT01806857