NCT00056524

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)

An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients With Pseudobulbar Affect.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Avanir Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is an "open label" study which means there is no placebo group. Each subject enrolled into the study will receive AVP-923.

Conditions

• Alzheimer's Disease
• Stroke
• Parkinson's Disease
• Traumatic Brain Injury

Interventions

Type	Name	Description
DRUG	AVP-923

Timeline

• Start date: 2003-02-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2003-03-18
• Last updated: 2016-07-14

Locations

39 sites across 1 country: United States