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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 39 Study Locations
Sponsors and Collaborators
Avanir Pharmaceuticals
  More Information

Additional Information:
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
Brain Injuries
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Tauopathies
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014