Clinical trial: Clinical Trial Nuedexta in Subjects With ALS (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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year.  Over the last few months, he has also noticed weakness in the right upper extremity.  BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor.  Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS.

Patient description (patient's own words): I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my  PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis.

Does the patient match the trial criteria? Entailment