Safety Study of AVP-923 in the Treatment of IEED (Involuntary Emotional Expression Disorder) Also Known as Pseudobulbar Affect (Episodes of Uncontrolled Crying and/or Laughter)

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the long-term safety of AVP-923 in the treatment of Involuntary Emotional Expression Disorder (IEED) also known as Pseudobulbar Affect (episodes of uncontrolled crying and/or laughter).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Avanir Pharmaceuticals

Criteria

Inclusion Criteria:

• 18 to 75 years of age, inclusive

• Clinical diagnosis of PBA (pseudobulbar affect)

• If female, must not be pregnant or breast feeding

Exclusion Criteria:

• Sensitivity to quinidine or any opiate drugs

• Current or prior history of major psychiatric disturbance

• Currently participated in a trial within the past 30 days