Trial Information

Summary: Frequent episodes of inappropriate laughing or crying that are out of proportion to the situation at hand, otherwise termed as emotion lability.

Individuals diagnosed with any neurological indication such as multiple sclerosis, stroke, ALS or Alzheimer’s disease and who have a history of frequent episodes of inappropriate laughing or crying that are out of proportion to the situation at hand, otherwise termed as emotional lability.

A clinical research study to assess the safety and effectiveness of a study drug which may alleviate the symptoms of pathological laughing and/or crying (pseudobulbar affect) in individuals with other neurological disorders.

Study inclusion criteria:

• The subject must be 18-75 years of age, inclusive
• The subject has a clinical history of pseudobulbar affect
• Female subjects must be using a medically accepted means of contraception

Study exclusion criteria:

• Female subjects who are either pregnant or nursing
• Subjects with myasthenia gravis
• Subjects with ventricular tachycardia or torsades de pointes
• Subjects with current or prior history of major psychiatric disturbance

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Trial listings updated: June 1, 2008 at 5:43:33 AM