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

Purpose

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.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: AVP-923	Phase III

MedlinePlus related topics:

Multiple Sclerosis

ChemIDplus related topics:

Avp 923

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Avanir Pharmaceuticals:

Primary Outcome Measures:

emotional control

Estimated Enrollment:	96
Study Start Date:	December 2002
Estimated Study Completion Date:	December 2004

Eligibility

Ages Eligible for Study:	18 Years to 68 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050232

Locations


United States, Arizona
	Barrow Neurological Institute
	Phoenix, Arizona, United States, 85013

United States, District of Columbia
	George Washington University Medical Faculty Associates
	Washington, District of Columbia, United States, 20037

United States, Florida
	Neurological Associates
	Ft. Lauderdale, Florida, United States, 33334

United States, Georgia
	Neurology & Headache Specialist of Atlanta, L.L.C.
	Decatur, Georgia, United States, 30033

United States, Illinois
	Consultants in Neurology LTD
	Northbrook, Illinois, United States, 60062
	Radiant Research Alexian Brothers
	Elk Grove Village, Illinois, United States, 60007

United States, Montana
	Advanced Neurology Specialists
	Great Falls, Montana, United States, 59405

United States, Nebraska
	Neurological Associates, P.C.
	Lincoln, Nebraska, United States, 68506

United States, New York
	Hospital for Joint Diseases - MS Care Center
	New York, New York, United States, 10003
	Upstate Clinical Research
	Albany, New York, United States, 12205
	Institute for Human Performance
	Syracuse, New York, United States, 13210
	DENT Neurologic Group L.L.P.
	Amherst, New York, United States, 14266

United States, North Carolina
	Raleigh Neurology Associates, P.A.
	Raleigh, North Carolina, United States, 27607

United States, Ohio
	NeuroCare Center, Inc.
	Canton, Ohio, United States, 44718

United States, Pennsylvania
	Leheigh Valley Neurosciences and Pain Research Center
	Allentown, Pennsylvania, United States, 18103
	Neurological Associates of Delaware Valley
	Upland, Pennsylvania, United States, 19013
	Westmorland Neurology
	Greensburg, Pennsylvania, United States, 15601

United States, Vermont
	FACH-UHC Department of Neurological Services
	Burlington, Vermont, United States, 05401

United States, Washington
	Swedish Medical Center
	Seattle, Washington, United States, 98122
	Neurology and Neurosurgery Associates of Tacoma
	Tacoma, Washington, United States, 98405

Sponsors and Collaborators

Avanir Pharmaceuticals

More Information

National Multiple Sclerosis Society This link exits the ClinicalTrials.gov site

Study ID Numbers:	02-AVR-106
First Received:	December 2, 2002
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00050232
Health Authority:	United States: Food and Drug Administration

Keywords provided by Avanir Pharmaceuticals:

Pseudobulbar Affect

Uncontrolled

Laughing

Crying

Study placed in the following topic categories:

Autoimmune Diseases

Multiple Sclerosis

Demyelinating Diseases

Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases

Sclerosis

Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes

Immune System Diseases

Nervous System Diseases

ClinicalTrials.gov processed this record on July 03, 2008

Sponsored by:	Avanir Pharmaceuticals
Information provided by:	Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00050232