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)

July 13, 2016 updated by: Avanir Pharmaceuticals

An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients With Pseudobulbar Affect.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

600

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
    • California
      • La Jolla, California, United States, 92037
        • Center for Neurologic Study
      • Los Angeles, California, United States, 90095
        • UCLA School of Medicine
      • San Francisco, California, United States, 94117
        • UCSF
    • Connecticut
      • Darien, Connecticut, United States, 06820
        • Research Center for Clinical Studies, Inc.
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University Medical Faculty Assoc.
    • Florida
      • Ft. Lauderdale, Florida, United States, 33334
        • Neurological Associates
      • Miami, Florida, United States, 33136
        • University of Miami Dept. of Neurology
      • Miami, Florida, United States, 33137
        • Miami Jewish Home & Hospital for the Aged
      • Miami, Florida, United States, 33181
        • Allied Clinical Trials
      • Plantation, Florida, United States, 33324
        • Renstar Medical Research
      • St. Petersburg, Florida, United States, 33701
        • Suncoast Neuroscience Associates Inc.
      • Tampa, Florida, United States, 33606
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Neurology & Headache Specialist of Atlanta, L.L.C.
    • Illinois
      • 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
        • SUNY Upstate Medical University
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology Associates, PA
    • Ohio
      • Canton, Ohio, United States, 44718
        • NeuroCare Center, Inc.
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44120
        • University Memory and Aging Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Clinical Pharmaceutical Trials, Inc.
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Neurosciences and Pain Research Center
      • Greensburg, Pennsylvania, United States, 15601
        • Westmoreland Neurology
      • Jenkintown, Pennsylvania, United States, 19046
      • Philadelphia, Pennsylvania, United States, 19107
        • Penn Neurological Institute
      • Philadelphia, Pennsylvania, United States, 19107
        • MCP-Hahnemann University
      • Upland, Pennsylvania, United States, 19013
        • Neurological Associates of Delaware Valley
    • Texas
      • Bellaire, Texas, United States, 77401
        • Claghorn-Lesem Research Clinic
      • Houston, Texas, United States, 77030
        • Methodist Neurological Institute
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care
    • Washington
      • Tacoma, Washington, United States, 98405
        • Neurology and Neurosurgery Associates of Tacoma
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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

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

February 1, 2003

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

March 15, 2003

First Submitted That Met QC Criteria

March 17, 2003

First Posted (Estimate)

March 18, 2003

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-107
  • AVP-923

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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