Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS
A Double-Blind Controlled, Multicenter Phase II/III Study to Assess the Safety and Efficacy of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect in Patients With Amyotrophic Lateral Sclerosis
  • Phase

    Phase 3
  • Study Type

  • Status

    Completed No Results Posted
  • Study Participants

The purpose of this study is to compare and evaluate the safety of AVP-923 (dextromethorphan/quinidine) for the treatment of emotional lability in ALS patients.
Study Started
Jan 31
Primary Completion
Apr 30
Study Completion
Apr 30
Last Update
Jul 14



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


Known sensitivity to quinidine or opiate drugs (codeine, etc.)
On any anti-depressive medication
Recently (within two months) diagnosed with ALS
Currently participating in, or who within the past 30 days have participated in, the study of another investigational new drug
Previously received treatment with co-administration of dextromethorphan and quinidine
History of substance abuse within the past two years
Women who are pregnant or likely to become pregnant during the course of the study
No Results Posted