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

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

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 and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients
Official Title ^†
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 ^†	Interventional
Study Design ^†	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measure ^†	emotional control
Secondary Outcome Measure ^†
Condition ^†	Multiple Sclerosis
Intervention ^†	Drug: AVP-923
MEDLINE PMIDs
Links	National Multiple Sclerosis Society

Recruitment Information Fields
Recruitment Status ^†	Completed
Enrollment ^†	96
Start Date ^†	December 2002
Completion Date	December 2004
Eligibility Criteria ^†	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 ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00050232
Organization ID	02-AVR-106
Secondary IDs ^††
Study Sponsor ^†	Avanir Pharmaceuticals
Collaborators ^††
Investigators ^†
Information Provided By	Avanir Pharmaceuticals
Verification Date	June 2007
First Received Date ^†	December 2, 2002
Last Updated Date	December 26, 2007

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