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) - Tabular View

Tracking Information
First Received Date ^ICMJE	March 15, 2003
Last Updated Date	August 4, 2009
Start Date ^ICMJE	February 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	emotional control
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00056524 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	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)
Official Title ^ICMJE	An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients With Pseudobulbar Affect.
Brief Summary	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).
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.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Condition ^ICMJE	Alzheimer's Disease Stroke Parkinson's Disease Traumatic Brain Injury
Intervention ^ICMJE	Drug: AVP-923
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	600
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00056524
Responsible Party
Study ID Numbers ^ICMJE	02-AVR-107, AVP-923
Study Sponsor ^ICMJE	Avanir Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Avanir Pharmaceuticals
Verification Date	August 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP