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

July 13, 2016 updated by: Avanir Pharmaceuticals
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

96

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurological Institute
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University Medical Faculty Associates
    • Florida
      • Ft. Lauderdale, Florida, United States, 33334
        • Neurological Associates
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Neurology & Headache Specialist of Atlanta, L.L.C.
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Radiant Research Alexian Brothers
      • Northbrook, Illinois, United States, 60062
        • Consultants in Neurology Ltd
    • Montana
      • Great Falls, Montana, United States, 59405
        • Advanced Neurology Specialists
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Neurological Associates, P.C.
    • New York
      • Albany, New York, United States, 12205
        • Upstate Clinical Research
      • Amherst, New York, United States, 14266
        • DENT Neurologic Group L.L.P.
      • New York, New York, United States, 10003
        • Hospital for Joint Diseases - MS Care Center
      • Syracuse, New York, United States, 13210
        • Institute For Human Performance
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology Associates, P.A.
    • Ohio
      • Canton, Ohio, United States, 44718
        • NeuroCare Center, Inc.
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Leheigh Valley Neurosciences and Pain Research Center
      • Greensburg, Pennsylvania, United States, 15601
        • Westmorland Neurology
      • Upland, Pennsylvania, United States, 19013
        • Neurological Associates of Delaware Valley
    • Vermont
      • Burlington, Vermont, United States, 05401
        • FACH-UHC Department of Neurological Services
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center
      • Tacoma, Washington, United States, 98405
        • Neurology and Neurosurgery Associates of Tacoma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
emotional control

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avanir Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

June 1, 2004

Study Completion (Actual)

June 1, 2004

Study Registration Dates

First Submitted

December 2, 2002

First Submitted That Met QC Criteria

December 2, 2002

First Posted (Estimate)

December 3, 2002

Study Record Updates

Last Update Posted (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 13, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-AVR-106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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