Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients - Tabular View

Tracking Information
First Received Date ^ICMJE	December 2, 2002
Last Updated Date	August 4, 2009
Start Date ^ICMJE	December 2002
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 NCT00050232 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients
Official Title ^ICMJE
Brief Summary	Pseudobulbar Affect is a condition characterized by frequent episodes of laughing and crying out of proportion. Other terms used to describe this condition include emotional lability, emotionalism, emotion incontinence, emotional discontrol, excessive emotionalism and pathological laughing and crying. AVP-923 is a new experimental drug that may assist in the reduction of uncontrolled episodes. This study will test the safety and efficacy of AVP-923 in the treatment of MS patients suffering from pseudobulbar affect.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Multiple Sclerosis
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
Enrollment ^ICMJE	96
Completion Date	December 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: 18 to 68 years of age Confirmed diagnosis of Multiple Sclerosis Clinical history of pseudobulbar affect Exclusion Criteria: Sensitivity to quinidine or opiate drugs Recent diagnosed within 2 months with Multiple Sclerosis Patient on anti-depressants Patient with liver or kidney disease Patient with hypotension
Gender	Both
Ages	18 Years to 68 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	NCT00050232
Responsible Party
Study ID Numbers ^ICMJE	02-AVR-106
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