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Completed Phase 3 Interventional

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)

ClinicalTrials.gov ID: NCT00056524

Public ClinicalTrials.gov record NCT00056524. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 4:20 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00056524
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Avanir Pharmaceuticals
Industry
Enrollment
600 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 2003 (Type not available)
Primary completion
Jun 2007 (Actual)
Completion
Jun 2007 (Actual)
Last update posted
Jul 14, 2016

2003 – 2007

United States locations

U.S. sites
39
U.S. states
18
U.S. cities
34
Facility City State ZIP Site status
Barrow Neurological Institute Phoenix Arizona 85013 —
Center for Neurologic Study La Jolla California 92037 —
UCLA School of Medicine Los Angeles California 90095 —
UCSF San Francisco California 94117 —
Research Center for Clinical Studies, Inc. Darien Connecticut 06820 —
George Washington University Medical Faculty Assoc. Washington D.C. District of Columbia 20037 —
Neurological Associates Fort Lauderdale Florida 33334 —
University of Miami Dept. of Neurology Miami Florida 33136 —
Miami Jewish Home & Hospital for the Aged Miami Florida 33137 —
Allied Clinical Trials Miami Florida 33181 —
Renstar Medical Research Plantation Florida 33324 —
Suncoast Neuroscience Associates Inc. St. Petersburg Florida 33701 —
Not listed Tampa Florida 33606 —
Neurology & Headache Specialist of Atlanta, L.L.C. Decatur Georgia 30033 —
Consultants in Neurology LTD Northbrook Illinois 60062 —
Advanced Neurology Specialists Great Falls Montana 59405 —
Neurological Associates, P.C. Lincoln Nebraska 68506 —
Upstate Clinical Research Albany New York 12205 —
DENT Neurologic Group L.L.P. Amherst New York 14266 —
Hospital for Joint Diseases MS Care Center New York New York 10003 —
SUNY Upstate Medical University Syracuse New York 13210 —
Carolinas Medical Center Charlotte North Carolina 28203 —
Raleigh Neurology Associates, PA Raleigh North Carolina 27607 —
NeuroCare Center, Inc. Canton Ohio 44718 —
MetroHealth Medical Center Cleveland Ohio 44109 —
University Memory and Aging Center Cleveland Ohio 44120 —
The Cleveland Clinic Foundation Cleveland Ohio 44195 —
Clinical Pharmaceutical Trials, Inc. Tulsa Oklahoma 74104 —
Lehigh Valley Neurosciences and Pain Research Center Allentown Pennsylvania 18103 —
Westmoreland Neurology Greensburg Pennsylvania 15601 —
Not listed Jenkintown Pennsylvania 19046 —
MCP-Hahnemann University Philadelphia Pennsylvania 19107 —
Penn Neurological Institute Philadelphia Pennsylvania 19107 —
Neurological Associates of Delaware Valley Upland Pennsylvania 19013 —
Claghorn-Lesem Research Clinic Bellaire Texas 77401 —
Methodist Neurological Institute Houston Texas 77030 —
Fletcher Allen Health Care Burlington Vermont 05401 —
Neurology and Neurosurgery Associates of Tacoma Tacoma Washington 98405 —
University of Wisconsin Madison Wisconsin 53792 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00056524, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 14, 2016 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00056524 live on ClinicalTrials.gov.

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