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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00050232
Recruitment Status : Completed
First Posted : December 3, 2002
Last Update Posted : July 14, 2016
Information provided by:
Avanir Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: AVP-923 Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : December 2002
Actual Primary Completion Date : June 2004
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Nuedexta

Primary Outcome Measures :
  1. emotional control

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00050232

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
Radiant Research Alexian Brothers
Elk Grove Village, Illinois, United States, 60007
Consultants in Neurology LTD
Northbrook, Illinois, United States, 60062
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
Upstate Clinical Research
Albany, New York, United States, 12205
DENT Neurologic Group L.L.P.
Amherst, New York, United States, 14266
Hospital for Joint Diseases - MS Care Center
New York, New York, United States, 10003
Institute for Human Performance
Syracuse, New York, United States, 13210
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
Westmorland Neurology
Greensburg, Pennsylvania, United States, 15601
Neurological Associates of Delaware Valley
Upland, Pennsylvania, United States, 19013
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

Additional Information:
Publications of Results: Identifier: NCT00050232     History of Changes
Other Study ID Numbers: 02-AVR-106
First Posted: December 3, 2002    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016

Keywords provided by Avanir Pharmaceuticals:
Pseudobulbar Affect

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases