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: May 5, 2014
Last verified: May 2014
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00050232     History of Changes
Other Study ID Numbers: 02-AVR-106
Study First Received: December 2, 2002
Last Updated: May 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Avanir Pharmaceuticals:
Pseudobulbar Affect
Uncontrolled
Laughing
Crying

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

ClinicalTrials.gov processed this record on August 18, 2014