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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:
ClinicalTrials.gov Identifier:
NCT00056524
First Posted: March 18, 2003
Last Update Posted: July 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Avanir Pharmaceuticals
  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
Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Avanir Pharmaceuticals:

Primary Outcome Measures:
  • emotional control

Estimated Enrollment: 600
Study Start Date: February 2003
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056524


  Show 39 Study Locations
Sponsors and Collaborators
Avanir Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00056524     History of Changes
Other Study ID Numbers: 02-AVR-107
AVP-923
First Submitted: March 15, 2003
First Posted: March 18, 2003
Last Update Posted: July 14, 2016
Last Verified: July 2016

Keywords provided by Avanir Pharmaceuticals:
ALS
MS
CNS
AD
TBI
Dextromethorphan
IEED
Emotional

Additional relevant MeSH terms:
Parkinson Disease
Alzheimer Disease
Brain Injuries
Brain Injuries, Traumatic
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Dementia
Tauopathies
Neurocognitive Disorders
Mental Disorders
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries