Clinical Trial of Neurodex for Pseudobulbar Affect in People with Amyotrophic Lateral Sclerosis
Enrollment Closed
Background
Avanir Pharmaceuticals is conducting an open label trial for patients experiencing pseudobulbar affect. In an open label trial design, all people receive the drug being tested and no people receive a placebo.
On June 20, 2002, Avanir Pharmaceuticals in San Diego, California announced positive results from a Phase II/III clinical trial that tested the safety and effectiveness of Neurodex. The research showed that use of Neurodex decreased the severity and frequency of pseudobulbar episodes and improved quality of life. The Phase II/III multi-center study was completed in Summer 2002 and included 140 patients with ALS. For more information on Neurodex and the clinical studies, please click on www.pseudobulbar.com.
Psuedobulbar affect is a condition characterized by episodes of uncontrolled laughing or crying that do not match a patient's underlying emotion. It is also known by other terms such as emotional lability or pathological laughing and crying. Pseudobulbar affect is a condition associated with a number of neurological disorders, including ALS. Symptoms may or may not be provoked and are generally not associated with the social setting or the person's actual feelings. Between 15-45% of people with ALS may experience this condition. The biologic mechanisms of how and why pseudobulbar affect occurs is not understood.
For many patients and their families, these symptoms are distressing and can sometimes be embarrassing. There are no medications specifically indicated to treat this symptom. However, some antidepressant medications are prescribed by physicians to treat pseudobulbar affect.
Neurodex is a combination of Dextromethorphan Hydrobromide (DM) and Quinidine Sulfate (Q). DM is a drug that is available without prescription as an over-the-counter cough suppressant. Quinidine Sulfate, a prescription drug, acts as an enzyme inhibitor that allows for "sustained, elevated levels of dextromethorphan in the body." Neurodex is not approved for use by the FDA at this time. The total daily dose of Q in this study is less than one tenth of the dose normally used to treat cardiac arrhythmias-its most common indication. Data from the Phase II/III study demonstrated that a combination of DM and Q reduced uncontrolled expressions of emotionality in patients with ALS.
Caution
Neurodex remains an investigational drug for the treatment of pseudobulbar affect in ALS. Unexpected adverse effects can occur. Do not take DM and Q without consulting with your physician or other health care provider. For more information about ALS and pseudobulbar affect, contact The ALS Association toll-free at (800) 782-4747, alsinfo@alsa-national.org.
For more information about treatments for pseudobulbar affect, contact your ALS neurologist or health care provider.
Study Design
The open label study is a multi-center study assessing the long-term safety of Neurodex over one year. Possible side effects include nausea, sleepiness, fatigue, dizziness, euphoria, confusion, rash or diarrhea.
Avanir Study Testing Locations and Contact Information
This study is being conducted at multiple sites throughout the U.S. For more information please visit www.pseudobulbar.com.
