Overview

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