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)

Avanir Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Traumatic Brain Injury; Alzheimer's Disease; Stroke; Parkinson's Disease

Treatments: Drug: AVP-923

Study type: Interventional

Funder types: Industry

Identifiers

NCT00056524

02-AVR-107

AVP-923

Details and patient eligibility

About

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).

Full description

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

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)