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

This study has been completed.

Sponsor:

Information provided by:

Avanir Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00050232

First received: December 2, 2002

Last updated: August 4, 2009

Last verified: August 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	December 2, 2002
Last Updated Date	August 4, 2009
Start Date ^ICMJE	December 2002
Primary Completion Date	Not Provided
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	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy of AVP-923 for Pseudobulbar Affect in Multiple Sclerosis Patients
Official Title ^ICMJE	Not Provided
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	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Multiple Sclerosis
Intervention ^ICMJE	Drug: AVP-923
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	96
Completion Date	December 2004
Primary Completion Date	Not Provided
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 Number ^ICMJE	NCT00050232
Other Study ID Numbers ^ICMJE	02-AVR-106
Has Data Monitoring Committee	No
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Avanir Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
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

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