Safety Study of AVP-923 in the Treatment of IEED (Involuntary Emotional Expression Disorder) Also Known as Pseudobulbar Affect (Episodes of Uncontrolled Crying and/or Laughter)

Last updated: July 13, 2016
Sponsor: Avanir Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Parkinson's Disease

Stroke

Alzheimer's Disease

Treatment

N/A

Clinical Study ID

NCT00056524
02-AVR-107
AVP-923
  • Ages 18-80
  • All Genders

Study Summary

The purpose of this study is to evaluate the long-term safety of AVP-923 in the treatment of Involuntary Emotional Expression Disorder (IEED) also known as Pseudobulbar Affect (episodes of uncontrolled crying and/or laughter).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 to 75 years of age, inclusive

  • Clinical diagnosis of PBA (pseudobulbar affect)

  • If female, must not be pregnant or breast feeding

Exclusion

Exclusion Criteria:

  • Sensitivity to quinidine or any opiate drugs

  • Current or prior history of major psychiatric disturbance

  • Currently participated in a trial within the past 30 days

Study Design

Total Participants: 600
Study Start date:
February 01, 2003
Estimated Completion Date:
June 30, 2007

Study Description

This is an "open label" study which means there is no placebo group. Each subject enrolled into the study will receive AVP-923.

Connect with a study center

  • Barrow Neurological Institute

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Center for Neurologic Study

    La Jolla, California 92037
    United States

    Site Not Available

  • UCLA School of Medicine

    Los Angeles, California 90095
    United States

    Site Not Available

  • UCSF

    San Francisco, California 94117
    United States

    Site Not Available

  • Research Center for Clinical Studies, Inc.

    Darien, Connecticut 06820
    United States

    Site Not Available

  • George Washington University Medical Faculty Assoc.

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • Neurological Associates

    Ft. Lauderdale, Florida 33334
    United States

    Site Not Available

  • Allied Clinical Trials

    Miami, Florida 33181
    United States

    Site Not Available

  • Miami Jewish Home & Hospital for the Aged

    Miami, Florida 33137
    United States

    Site Not Available

  • University of Miami Dept. of Neurology

    Miami, Florida 33136
    United States

    Site Not Available

  • Renstar Medical Research

    Plantation, Florida 33324
    United States

    Site Not Available

  • Suncoast Neuroscience Associates Inc.

    St. Petersburg, Florida 33701
    United States

    Site Not Available

  • Tampa, Florida 33606
    United States

    Site Not Available

  • Neurology & Headache Specialist of Atlanta, L.L.C.

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Consultants in Neurology LTD

    Northbrook, Illinois 60062
    United States

    Site Not Available

  • Advanced Neurology Specialists

    Great Falls, Montana 59405
    United States

    Site Not Available

  • Neurological Associates, P.C.

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • Upstate Clinical Research

    Albany, New York 12205
    United States

    Site Not Available

  • DENT Neurologic Group L.L.P.

    Amherst, New York 14266
    United States

    Site Not Available

  • Hospital for Joint Diseases MS Care Center

    New York, New York 10003
    United States

    Site Not Available

  • SUNY Upstate Medical University

    Syracuse, New York 13210
    United States

    Site Not Available

  • Carolinas Medical Center

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Raleigh Neurology Associates, PA

    Raleigh, North Carolina 27607
    United States

    Site Not Available

  • NeuroCare Center, Inc.

    Canton, Ohio 44718
    United States

    Site Not Available

  • MetroHealth Medical Center

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University Memory and Aging Center

    Cleveland, Ohio 44120
    United States

    Site Not Available

  • Clinical Pharmaceutical Trials, Inc.

    Tulsa, Oklahoma 74104
    United States

    Site Not Available

  • Lehigh Valley Neurosciences and Pain Research Center

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • Westmoreland Neurology

    Greensburg, Pennsylvania 15601
    United States

    Site Not Available

  • Jenkintown, Pennsylvania 19046
    United States

    Site Not Available

  • MCP-Hahnemann University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Penn Neurological Institute

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Neurological Associates of Delaware Valley

    Upland, Pennsylvania 19013
    United States

    Site Not Available

  • Claghorn-Lesem Research Clinic

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Methodist Neurological Institute

    Houston, Texas 77030
    United States

    Site Not Available

  • Fletcher Allen Health Care

    Burlington, Vermont 05401
    United States

    Site Not Available

  • Neurology and Neurosurgery Associates of Tacoma

    Tacoma, Washington 98405
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 53792
    United States

    Site Not Available

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