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)

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).

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Basal Ganglia Diseases Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Dementia Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinson Disease Parkinson's Disease Parkinsonian Disorders Stroke Synucleinopathies Tauopathies Trauma, Nervous System Traumatic Brain Injury Vascular Diseases Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Barrow Neurological Institute, Phoenix, Arizona, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AVP-923

Drug

Primary outcomes

emotional control

Sponsors and collaborators

Lead sponsor

Avanir Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2007
Study completion: 2007
First posted: Mar 18, 2003
Registry last updated: Jul 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed