Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS

Inclusion Criteria

• •Inclusion:
• •18 to 80 years of age, inclusive
• •Confirmed diagnosis of ALS or probable ALS
• •Clinical history of pseudobulbar affect
• •If female, must not be pregnant, breast-feeding, or planning a pregnancy during the course of the study, and must have a negative urine pregnancy test prior to start of study
• •If female, must have been practicing an established method of birth control for at least the prior month (oral contraceptive tablets, hormonal implant device, intrauterine device, diaphragm and contraceptive cream or foam, condom with spermicide, tubal ligation, or abstinence) or be surgically sterile or post-menopausal
• •Must be willing to not take any prohibited medications during participation in the study
• •Exclusion:
• •Known sensitivity to quinidine or opiate drugs (codeine, etc.)
• •On any anti-depressive medication
• +5 more criteria