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) - Full Text View

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)

This study has been completed.

Sponsored by:	Avanir Pharmaceuticals
Information provided by:	Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00056524

Purpose

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).

Condition	Intervention	Phase
Alzheimer's Disease Stroke Parkinson's Disease Traumatic Brain Injury	Drug: AVP-923	Phase III

Genetics Home Reference related topics:

Alzheimer disease Parkinson disease Stroke

MedlinePlus related topics:

Alzheimer's Disease Head and Brain Injuries Parkinson's Disease

ChemIDplus related topics:

Dextromethorphan Dextromethorphan hydrobromide Levomethorphan Racemethorphan Avp 923

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

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

Further study details as provided by Avanir Pharmaceuticals:

Primary Outcome Measures:

emotional control

Estimated Enrollment:	600
Study Start Date:	February 2003

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00056524

Show 39 Study Locations

Sponsors and Collaborators

Avanir Pharmaceuticals

More Information

Click here for more information about Involuntary Emotional Expression Disorder (also known as pseudobulbar affect, emotional lability, or uncontrolled laughter and crying) This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Study ID Numbers:	02-AVR-107, AVP-923
First Received:	March 15, 2003
Last Updated:	December 17, 2007
ClinicalTrials.gov Identifier:	NCT00056524
Health Authority:	United States: Food and Drug Administration

Keywords provided by Avanir Pharmaceuticals:

ALS

CNS

TBI

Dextromethorphan

IEED

Emotional

Study placed in the following topic categories:

Craniocerebral Trauma

Ganglion Cysts

Cerebral Infarction

Basal Ganglia Diseases

Alzheimer Disease

Stroke

Wounds and Injuries

Central Nervous System Diseases

Trauma, Nervous System

Brain Diseases

Neurodegenerative Diseases

Cognition Disorders

Delirium, Dementia, Amnestic, Cognitive Disorders

Movement Disorders

Parkinson Disease

Dextromethorphan

Parkinsonian Disorders

Brain Injuries

Dementia

Delirium

Additional relevant MeSH terms:

Mental Disorders

Nervous System Diseases

Disorders of Environmental Origin

Tauopathies

ClinicalTrials.gov processed this record on July 03, 2008