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

Avanir Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Amyotrophic Lateral Sclerosis

Treatments

Drug: AVP-923

Study type

Interventional

Funder types

Industry

Identifiers

NCT00021697

AVP-923

99-AVR-102

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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
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