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.

First Received: March 15, 2003 Last Updated: August 4, 2009 History of Changes

Sponsor:	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

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.

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Alzheimer's Disease Parkinson's Disease Traumatic Brain Injury

Drug Information available for: Avp 923

U.S. FDA Resources

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

Additional 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

No publications provided

Study ID Numbers:	02-AVR-107, AVP-923
Study First Received:	March 15, 2003
Last Updated:	August 4, 2009
ClinicalTrials.gov Identifier:	NCT00056524 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Avanir Pharmaceuticals:

ALS
MS
CNS
AD

TBI
Dextromethorphan
IEED
Emotional

Additional relevant MeSH terms:

Craniocerebral Trauma
Alzheimer Disease
Nervous System Diseases
Basal Ganglia Diseases
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System
Brain Diseases

Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Movement Disorders
Parkinson Disease
Mental Disorders
Parkinsonian Disorders
Brain Injuries
Dementia
Tauopathies

ClinicalTrials.gov processed this record on November 09, 2009