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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.
Sponsor:
Information provided by:
Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00056524
First received: March 15, 2003
Last updated: August 4, 2009
Last verified: August 2009
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

Drug Information available for: Nuedexta
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

No publications provided

ClinicalTrials.gov Identifier: NCT00056524     History of Changes
Other Study ID Numbers: 02-AVR-107, AVP-923
Study First Received: March 15, 2003
Last Updated: August 4, 2009
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:
Alzheimer Disease
Parkinson Disease
Stroke
Brain Injuries
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
 Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013