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

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	Related Studies

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.
Information provided by Avanir Pharmaceuticals

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	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 ^†	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 ^†	Interventional
Study Design ^†	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Primary Outcome Measure ^†	emotional control
Secondary Outcome Measure ^†
Condition ^†	Alzheimer's Disease Stroke Parkinson's Disease Traumatic Brain Injury
Intervention ^†	Drug: AVP-923
MEDLINE PMIDs
Links	Click here for more information about Involuntary Emotional Expression Disorder (also known as pseudobulbar affect, emotional lability, or uncontrolled laughter and crying)

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	600
Start Date ^†	February 2003
Completion Date
Eligibility 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
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00056524
Organization ID	02-AVR-107
Secondary IDs ^††	AVP-923
Study Sponsor ^†	Avanir Pharmaceuticals
Collaborators ^††
Investigators ^†
Information Provided By	Avanir Pharmaceuticals
Verification Date	December 2007
First Received Date ^†	March 15, 2003
Last Updated Date	December 17, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.