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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
 

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  
MS  
CNS  
AD  
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




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